The Use of Functional Electrical Stimulation in Adult Stroke Patients to Improve Functional
Outcomes: A Case Report
Bob Graham, SPT
Abstract –
Study Design – Case report.
Background/purpose – Stroke is a leading cause of death in the United States. About 795,000 people have
a stroke each year in the United States. Functional Electrical Stimulation cycling is a method of using
electrical stimulation therapy while cycling on a stationary cycle to improve motor and sensory pathways to
improve functional outcomes. The case study quantitatively evaluates the extent that the use of FES
cycling may improve functional outcomes in stroke patients with hemiplegia or hemiparesis.
Case Description – A 53-year-old male who was initially admitted to a local hospital with a chief complaint
of severe headache, left facial weakness, left-sided hemiweakness and slurred speech after hitting his
head from a fall in his home. His exam was significant for NIH stroke scale of 16, initial blood pressure of
193/117 mm Hg, and a diagnostic CT positive for stroke. The patient was transferred for a neurosurgery
consult to a 2nd local hospital. Imaging showed a large ischemic hemispheric stroke in the perfusion
territory of the right middle cerebral artery affecting the basal ganglia, frontal, parietal, temporal lobe.
Outcomes and Discussion – At the time of discharge the patient remained a fall risk with a Berg Balance
score of 5/56, was impulsive, and had decreased safety awareness and decreased cognition. He still
needed moderate assistance with bed mobility, transfers, sit to stand task and ambulation. The patient did
not meet any of his long-term goals including bed mobility, transfers, gait ambulation or wheel chair
ambulation.
1 Level of Evidence – Therapy, level 4.
Key Words – stroke, functional electrical stimulation
Section 1 – Background and purpose – The client was a 53 y/o male diagnosed with a large acute
nonhemorrhagic right middle cerebral artery (MCA) infarct from a head trauma on December 30, 2012.
Follow up MRI showed it affect to the basal ganglia, frontal, parietal, temporal lobes. The client had left
hemiparesis and severe neglect of the left side. He had a past medical history of alcoholism, hypertension,
hypercholesterolemia, and long standing tobacco abuse. There is a family history of stroke on his mother’s
side. He was admitted to sub-acute inpatient rehab on January 7, 2013. The patient presented on
evaluation as max assist to dependent for all bed mobility, transfers, gait and ADLs with poor static &
dynamic sitting and standing static balance. While working with the patient I became interested in methods
to help facilitate return of motor function to the affected side of the body and ways to improve functional
outcomes. There was a functional electrical stimulation cycling device available at the facility where I was
working and we chose it for some of the treatment interventions. I began to wonder what the research was
saying about such treatment for the use of stroke rehabilitation in patients with motor deficits.
Background – Stroke is a leading cause of death in the United States and about 795,000 people have a
stroke each year.(1) The effects can range from minor problems to major impairments with paralysis of one
side of the body, changes in speech, and impaired cognition with lasting disability. Ischemic stroke
accounts for about 87% of all strokes. Some of the common disabilities observed in ischemic stroke
survivors at 6 months post incident are: hemiparesis in 50%, inability to walk without assistance in 30%,
dependence in activities of daily living 26%, and institutionalization in a nursing home for 26%. These
2 disabilities can leave physical, psychological and economic strain on the patient and family. Finding
effective rehabilitation interventions to help the patient gain back their independence is of utmost
importance.
Common interventions used are posture retraining, functional mobility, gait training, different types of
handling techniques and Neurodevelopment Technique (NDT), motor re-learning approach, body weight
supported treadmill training, strength training, and treadmill training to name a few. A newer tool for stroke
rehabilitation is the functional electrical stimulation cycle that allows lower extremity and upper extremity to
perform cycle ergometry either alone or together with electrical stimulation. One of the benefits of using
this device is that less physical handling is needed by the therapist. The patient can be brought up to the
device in a wheel chair, connected to it and exercised without need for transfer or facilitation of movement.
The cycling type of device allows movement of bilateral extremities in a rhythmic and reciprocal fashion,
similar to that which is needed for human gait. In a study by Yan T, Hui-Chan C, and Li L in 2005 they
used functional electrical stimulation to the quadriceps, hamstrings, tibialis anterior, and gastrocnemius to
the involved leg while it was suspended in a sling from the ceiling and mimicked a walking gait pattern to
the involved side. Results showed that 84.6% of the FES intervention group was able to walk after the 8
week treatment period while 60% of the placebo FES group and 46.2% of the control group were able to
walk after the intervention. In addition, the FES intervention group had 84% of the patients return home as
compared to 53% of the placebo FES group and 46% of the control group. They theorized that this
repetitive movement intervention might have positive neuroplasticity affects and aid in skill acquisition.(2)
There may be additional benefits to using FES to help promote cortical adaptations similar to those of
learning a new task. This occurs primarily in the pre-motor cortex and primary motor cortex.(3)
These findings compelled me to search the literature to identify the role that functional electrical stimulation
cycling could play in stroke rehabilitation. I came up with the PICO question of: In adult stroke patients
3 with hemiparesis/hemiplegia, will the use of functional electrical stimulation cycling improve their functional
outcomes?
CASE DESCRIPTION
A 53-year-old male who was initially admitted to a local Albuquerque hospital and later transferred for a
neurosurgery consult to a 2nd local hospital. The patient woke up on December 30th in his normal state of
health. He had a fall in the home and hit his head; he did not lose consciousness but believed he had a
concussion. He had a chief complaint of severe headache, left facial weakness, left-sided hemiweakness
and slurred speech. His exam was significant for NIH stroke scale of 16, initial blood pressure of 193/117
mm Hg, and a diagnostic CT positive for stroke. The patient was transferred for a neurosurgery consult to
a 2nd local hospital. Imaging showed a large ischemic hemispheric stroke in the perfusion territory of the
right middle cerebral artery affecting the basal ganglia, frontal, parietal, temporal lobe. After monitoring it
was determined that a hemicraniectomy to decompress the intracranial pressure was not indicated. He
was stabilized and transferred to a local inpatient rehab hospital on January 7, 2013.
Examination
History –
The initial evaluation and examination took place on January 8, 2013. The patient lives in Albuquerque
with his wife and works full time in maintenance. The patient experienced the onset of his symptoms after
a fall on December 30th where he hit his head and did not lose consciousness but believed he suffered a
concussion. He presented to the local hospital and had a NIH stroke scale score of 16 and was given TPA.
His symptom onset was at 7:30 AM and his TPA administered at 8:55 AM. He was admitted to
neurosurgery at which time a midline shift was noted which prompted transfer to the 2nd area hospital for
neurosurgery consult. MRI performed on December 30 showed a large hemispheric stroke in the perfusion
4 territory of the right middle cerebral artery affecting the basal ganglia, frontal, parietal, temporal lobe. A CT
of the head showed no interval intracranial hemorrhage, no hydrocephalus, and no abnormal extra-axial
fluid collection.
Current complaints and symptoms: headache, left hemiparesis, neglect, and inability to walk
Medical Diagnosis: Ischemic Cerebrovascular accident (CVA) with left hemiparesis and severe neglect,
Traumatic brain injury (TBI)
Past medical history:
1. Alcoholism (ETOH)
2. Questionable hypertension
3. Questionable hypercholesterolemia
4. Long-standing tobacco abuse since the age of 10.
Past surgical history:
None.
Allergies:
Penicillin.
Family History:
His mother had a stoke at the age of 55; his grandfather also had a stroke at an unknown age.
Social history:
5 He lives with his wife and many pets in a single story home in Albuquerque. He drinks one pint of tequila
and a six-pack of beer twice a week. He smokes a pack and a half a day for 40 years.
Goals:
The patient would like to get back to being independent in all aspects of his life.
Systems Review
Cardiovascular/pulmonary: vital signs are stable
Integumentary: unremarkable
Musculoskeletal: hemiparesis on Left
Neuromuscular: impaired sensation, proprioception and coordination on Left
Cognitive: combative, impulsive, and confused.
Tests and Measures:
At the time of the initial evaluation on January 8 he was found to have hemiparesis of the left side of the
body with MMT scores of 0/5 of the UE, and hip flexion & hip extension of 1/5, hip abduction and adduction
of 2+/5, with knee and ankle motor of 0/5 on the left; UE of 4+/5 and LE 4/5 on right. PROM was WFL
bilaterally. He had impaired coordination, sensation and proprioception on left side, with normal
examination on the right. The patient was max assist for bed mobility, all transfers and dependent for
tub/shower and ambulation as well as wheelchair mobility. The patient was dependent for toileting,
dressing, bathing, mod assist for grooming and min assist for eating. The patient was noted to be
impulsive, combative and confused. Communication/cognition FIM scores of 2 to 4. No pain was noted on
evaluation.
Berg Balance Test: 0/56 administered on 1/09/13
6 Berg Balance Test: 5/56 administered on 1/29/13
Evaluation
Diagnosis - Medical Diagnosis: ICD 9 code: 434.01 Middle cerebral artery infarction (stroke), thrombotic.
Physical therapy diagnosis: Pattern 5D: Impaired Motor Function and Sensory Integrity Associated With
Nonprogressive Disorders of the Central Nervous System - Acquired in Adolescence or Adulthood
Narrative Assessment – The patient is a 53 year-old male who suffered a cerebral vascular accident on
December 30, 2012 with left sided hemiparesis and severe left neglect. The patient demonstrates
decreased functional mobility, gait and impairments in muscle strength and sensation. The patient would
benefit from skilled physical therapy intervention at this time to address left side weakness, inability to
ambulate, and decreased ability in bed mobility and transfers. The patient has a good rehabilitation
potential and shows enthusiasm to proceed.
Clinical judgments and problem list –
Impairments:
Left sided weakness
Impaired sensation left side
Left side neglect
Functional limitations:
Walking
Wheelchair mobility
Bed mobility
7 Transfers
Participation restrictions:
Role as a husband
Employment as a maintenance person
Discussion This is a fairly complex patient with chronic long-standing tobacco and alcohol abuse, a family history of
stroke, and questionable ability of his spouse to care for the patient upon his return home. The fact that he
is only 53 years old should benefit his recovery. The patient has severe neglect, decreased sensation and
strength making all functional mobility difficult, also impeding recovery is the fact he lacks insights into the
severity of his impairments. He will likely need further long-term care to address ongoing deficits.
Prognosis –
Long Term Goals:
1. Patient will be modified independent with all bed mobility in 30 days.
2. Patient will be supervision level in all bed to chair transfers in 30 days.
3. Patient will be minimum assist in gait x 50 feet with appropriate level of assistive device in 30 days.
4. Patient will be modified independent in all wheel chair mobility x 200 feet, including set up and tear
down in 30 days.
Short Term Goals:
1. Patient will be modified assist in all bed mobility in 7 days.
8 2. Patient will be modified assist in all bed to chair transfers in 7 days.
3. Patient will be modified assist in gait x 10 feet at counter in 7 days.
4. Patient will be minimum assist in all wheel chair mobility x 150 feet in 7 days.
Plan of Care:
Physical Therapy 5-7 days a week for 1 hour per day for a period of 30 days.
Based on the algorithm 1.801 x NIHSS = Length of stay (LOS) = 1.801 x 16 = 28.816 days.(4) It would be
expected that the patient be discharged to a skilled nursing home for further long-term care. The patient
would be expected to reach a level of modified independent to independent in all activities of daily living
and return his prior level of function.
Using the NIHSS-time score formula allowed me to predict the outcome of this patient and come up with a
percentage for likelihood of coming out with a good or poor outcome.(5) This was calculated as:
NIHSS-time score formula: NIHSS – time score = initial NIHSS score x OTT (h).
NIHSS – time score = 16 x 1.42 h
NIHSS – time score = 22.72 then you round off to 1 decimal place
NIHSS – time score = 22.7
Utilizing this NIHSS – time score of 22.7 we find from their table that the likelihood of a good outcome
(mRS 0-1) = 38.9%, and the likelihood of a poor outcome (mRS 4-6) = 31.9%.
Using these numbers indicates this patient would have a 61.1% probability of an mRS score of between 26, which would range from slight disability to severe disability or death. Multivariate logistic regression
analysis revealed NIHSS-time score as an independent predictor of both good (OR, 0.587; 95%CI, 1.2272.514; p=0.002) and poor outcome (OR, 1.756; 95%CI, 1.227–2.514; p = 0.002).
The NIHSS score was found to be significantly associated with clinical outcomes, supporting the findings
from sub-analysis of the NINDS rt-PA trial.(6) The proportion of patients with a modified Rankin Scale
9 scores of 0-1 at 3 month follow up was 23.3% among patients with a NIHSS score of > 15. A modified
Rankin scale score of 0 = no symptoms at all, and a score of 1 = no significant disability despite symptoms;
able to carry out all usual duties and activities. Based on the NIHSS – time score = 22.7 it appears there is
~ 60% chance that this patient will have at least a slight disability, which would require some help. Based
on the patient’s NIHSS of 16, his likelihood of a mRS score of 2-6 is 76.7%. There is a strong chance this
patient will have slight to severe disability and need assistance with aspects of his life.
INTERVENTIONS
Safety education, family/care giver training, gait training, gait training with FES cycling training, transfer
training, bed mobility training, aerobic training using nu-step, w/c mobility training, therapeutic exercise,
neuromuscular re-education, sensory stimulation, and biofeedback.
The intervention plan was to provide functional training to realign midline orientation, training in
compensatory strategies to perform functional mobility tasks, education to patient and family for safety and
assistance with self care, gait training, aerobic training for conditioning, neuromuscular re-education to help
regain functional movement and balance, and education about lifestyle modifications to aid recovery.
Outcomes – The patient was being recommended for discharge to SNF for ongoing rehabilitation as he
remained a fall risk, was impulsive, and had decreased safety awareness and decreased cognition. He still
needed assistance with bed mobility, transfers, sit to stand task and ambulation. The patient was
discharged home secondary to limited insurance benefits, no SNF benefit, as well as denied Medicaid
benefit. The patient did not meet any of his long-term goals including bed mobility, transfers, gait
ambulation or wheel chair ambulation. The patient still needed assistance due to his strength, sensory and
cognitive deficits. The patient had a Berg Balance score of 5/56 on 1/29/2013, which demonstrated that he
10 was a 100% fall risk. He was able to walk with moderate assistance and use of a counter with his right
upper extremity for a distance of 30 feet before fatigue.
EVIDENCE BASE ANALYSIS:
Methodologies of Search:
Pico Question: In adult stroke patients with hemiparesis/hemiplegia will the use of functional electrical
stimulation cycling improve their functional outcomes?
Databases used:
Pedro, Pubmed, CINHAL, Science Direct, Hooked on Evidence, & Cochrane
Search terms: functional electrical stimulation cycling, stroke, hemiparesis, hemiplegia, and functional
outcomes.
From this search I was able to find 21 articles that matched my search criteria. From here 13 were
excluded because they were not closely enough related to my PICO question, which left me with 8 articles
to evaluate.
See Table 1 for search methodologies and selection criteria.
I read and analyzed each article using a standard analysis worksheet that is attached in the appendix. A
summary of each article has been provided with an overall impression of the study.
See Table 2 for a table summarizing the studies outcomes and whether they helped answer the PICO
question.
Discussion – The use of Functional Electrical Stimulation cycling for stroke rehabilitation is a newer area of
neurological rehabilitation that has not had a lot of research focused on its effectiveness to date. I was able
to find 8 articles of varying levels of evidence analyzing its effectiveness. An RCT of n = 20 stroke patients
by Lo HC, et al(7) findings supported a positive effect using 1 session of cycling with or without FES to
11 improve postural control and help reduce spasticity in hemiplegia patients. Greater benefit was found for
patients with higher levels of spasticity using the FES assisted cycling. This Oxford level 2b evidence did
have threats to internal and external validity and a small sample that made it more difficult to generalize to
my patient but there was little risk to try the intervention.
An RCT of n = 30 patients with hemiparesis by Ambrosini E, et al.(8) found that a 4 week treatment of FES
cycling helped to improve motor recovery and walking ability in subacute stroke patients. This Oxford level
2b evidence had good control and was a high quality study with a 3 to 5 month follow-up showing a main
effect in favor of the treatment. This would be an intervention worth using in the clinic.
An RCT of n = 30 patients with hemiparesis by Ambrosini E, et al.(9) found that a 4 week treatment FES
cycling helped to improve muscle activation and symmetry of pedaling, suggesting improved involvement of
the hemiparetic leg. This Oxford level 2b evidence was of high quality and good control with a 3 to 5 month
follow-up showing a main effect in favor of the treatment. This would be an intervention worth using in the
clinic.
An RCT of n = 20 patients with subacute hemiplegia by Ambrosini E, et al.(10) found that a 4 week
intervention of FES cycling had significant improvements in motor strength and motor recovery than
physical therapist assisted standard rehabilitation only. The entire intervention group recovered the ability
to perform the sit to stand task at 3 different rising speeds while 0 of the standard rehab group did. This
Oxford level 2b evidence was of high quality and control but did have a small sample size. It is hard to
generalize the results because of this, but it would be an intervention worth trying in the clinic.
An RCT of n = 16 patients with chronic hemiparesis by Janssen TW, et al.(11) found that a 6 week bout of
cycling training can significantly improve cycling performance, aerobic capacity, and functional
performance. Significant improvements for both FES cycling and non FES cycling group for increases in
VO2 max, Berg Balance test scores, 6MWT times, with non significant increases in muscular strength. This
12 Oxford level 2b evidence was of moderate quality and control showing that there was good effect of cycling
training for chronic stroke with little additional benefit for the FES assisted cycling.
A within subject comparison study of n = 16 sub acute stroke patients by Yeh C-U, et al.(12) found that a
single session of cycling with or without FES helped to reduce muscle tone. The use of FES to the affected
leg was more effective at reducing tone. This Oxford level 3 evidence did not have a control group, was a 1
time intervention with no follow up to evaluate what the lasting effects were. The small sample limits the
power of the study and the generalization of its use across populations. There is very little risk of using this
treatment in the clinic for someone with spasticity.
A cross-sectional study of n = 39 sub-acute hemiparesis patients by Szecis J, et al.(13) found that the main
effect of a single session of FES assisted cycling was an improvement in smoothness of cycling more than
an increase in muscle power. This Oxford level 3 evidence did not have a control group was not random
and was a short term 1 day intervention so I did not find this study to be very compelling. It contradicted
some of the other studies of higher quality with control groups and randomized design. The authors
theorize that over time a strengthening could occur but without a longer intervention and follow up for
treatment effect they could not see this trend.
A case series design study of n = 12 chronic hemiparetic patients by Alon G, et al.(14) found that an 8 week
intensive FES cycling training protocol significantly improved the get up and go test times, gait velocity, and
peak pedaling power. This is Oxford level 4 evidence without a control group and with a small sample size
of 12, which limits our ability to generalize the outcomes. The patients were between 2 – 37 years post
stroke and utilized an intensive training protocol that would not be appropriate for a sub-acute population so
I would not feel that it is safe to use for my subject. The findings are compelling because they achieved
good results using this high intensity format but there should really be a larger randomized clinical trial to
verify results.
13 Conclusion - The 8 studies that I reviewed did provide me with enough insight as to answering my PICO
question: In adult stroke patients with hemiparesis/hemiplegia will the use of functional electrical
stimulation cycling improve their functional outcomes? From the above evidence I feel there is ample
evidence to use this intervention clinically as it does improve functional outcomes. There is higher quality
Oxford level 2b evidence supporting the use of FES cycling for increasing functional outcomes in sub-acute
stroke patients with hemiplegia or hemiparesis. In general, there was low risk of trying the suggested
interventions with good outcomes for cycling and FES assisted cycling for improvements in areas such as
motor strength, symmetry, postural control, motor recovery, balance, sit to stand tasks, 6MWT, get up and
go times, and decreasing muscle tone. As a clinician I would use this as a one of my interventions to assist
the client in their rehabilitation. It is not clear from the research what the therapeutic dose is to see these
results, it seems 2-3 times a week for 20 minutes for 4 to 6 weeks was an average. In the future I would try
to use this tool more frequent then I did with this patient, up to 2-3 times a week, and for a longer period of
time, up to 6 weeks. I would also apply the electrodes to the gluteal, quadriceps, hamstrings and tibialis
anterior muscles as that is what most of the protocols called for. We were not stimulating the gluteal
muscles during our training sessions. So with these modifications to dose and application I would utilize
this tool as one of my interventions for rehabilitation of a stroke patient with hemiparesis/hemiplegia.
14 References:
1. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and
stroke statistics—2012 update: a report from the American Heart Association. Circulation.
2012;125(1):e2–220. (this is the AHA’s paper about hd and stroke.)
2. Yan T, Hui-Chan CW, Li LS. Functional electrical stimulation improves motor recovery of the lower
extremity and walking ability of subjects with first acute stroke- a RCT placebo controlled trail.
Stroke. 2005;36(1):80-5
3. Velasques B, Cunha M, Machado S, Minc D, Abrumhosa A, Silva A, et al. Changes in slow and
fast alpha bands in subjects submitted to different amounts of functional electrostimulation.
Neurosci Lett. 2008;441(2):149-52.
4. Elwood D, Rashbaum I, Bonder J, Pantel A, Berliner J, Yoon S, et al. Length of stay in
rehabilitation is associated with admission neurologic deficit and discharge destination. PM R.
2009;1(2):147-51.
5. Aoki J, Kimura K, Koga M, Kario K, Nakagawara J, Furui E, et al. NIHSS-time score easily predicts
outcomes in rt-PA patients: the SAMURAI rt-PA registry. J Neurol Sci. 2013;327(1-2):6-11.
6. Saver JL, Yafeh B. Confirmation of tPA treatment effect by baseline severity-adjusted end point
reanalysis of the NINDS-tPA stroke trials. Stroke. 2007;38(2):414-6
7. Lo HC, Hsu YC, Hsueh YH, Yeh CY. Cycling exercise with functional electrical stimulation
improves postural control in stroke patients. Gait Posture. 2012;35(3):506-10.
8. Ambrosini E, Ferrante S, Pedrocchi A, Ferrigno G, Molteni F. Cycling induced by electrical
stimulation improves motor recovery in postacute hemiparetic patients. Stroke. 2011;42(4):106873.
9. Ambrosini E, Ferrante S, Ferrigno G, Molteni F, Pedrocchi A. Cycling induced by electrical
stimulation improves muscle activation and symmetry during pedaling in hemiparetic patient. IEEE
Trans Neural Syst Rehabil Eng. 2012;20(3):320-30.
10. Ferrante S, Pedrocchi A, Ferrigno G, Molteni F. Cycling induced by functional electrical stimulation
improves the muscular strength and the motor control of individuals with post-acute stroke. Eur J
Phys Rehabil Med. 2008:44(2):159-67.
11. Janssen TW, Beltman JM, Elich P, Koppe PA, Konijnenbelt H, de Haan A, Gerrits KH. Effects of
electrical stimulation-assisted cycling training in people with chronic stroke. Arch Phys Med
Rehabil 2008;89(3):463-9
12. Yeh C-U, Tsai KH, Su FC, Lo HC. Effect of a bout of leg cycling with electrical stimulation on
reduction of hypertonia in patients with stroke. Arch Phys Med Rehabil. 2010;91(11):1731-6.
15 13. Szecis J, Krewer C, Muller F, Straube A. Functional electrical stimulation assisted cycling of
patients with subacute stroke: kinetic and kinematic analysis. Clin Biomech. 2008;23(8):1086-94.
14. Alon G, Conroy VM, DonnerTW. Intensive training of subjects with chronic hemiparesis on a
motorized cycle combined with FES: A feasibility and safety study. Physiother Res Int.
2011;16(2):81-91.
16 Table 1: Methodology of Search
Pubmed 810: 2 search terms Cochrane CINHAL Science Direct 4: 2 search terms 214: 2 search terms 65: 3 search terms 20 4 9 60 93 Total Articles (Relevant to Topic) 11 0 2 8 8 studies used with outcomes of: Tone & postural control Motor recovery Strength Balance & Gait = 17 See Table 2 18 See Table 2 19 See Table 2 20 Appendix:
Cycling exercise with functional electrical stimulation improves postural control in
stroke patients. Lo HC, Hsu YC, Hsueh YH, Yeh CY. Gait Posture. 2012 Mar;35(3):506-10.
Oxford Level of evidence: 2b
Pedro Score: 4/10
Purpose: to determine if a short-term FES-cycling program can improve the postural control of stroke
subjects, and to verify that the application of FES in cycling programs is more effective than without such
application.
Methods: RCT, comparative study, n =20, 20 stroke patients, randomly assigned to FES cycling group
(FES-CG) n = 10, gender M/F 7/3, age 47.62+3.28, type of stroke H/I 6/4, time since stroke (months) 25.54
+12.95, side of hemiplegia R/L 5/5; or cycling group (CG) gender m/f 9/1, age 51.64 + 3.41 yrs. old, 167.74
+ 2.67 cm, h/I 5/5, 29.64+ 10.36 months since stroke, side of hemi R/L 6/4.
Each training protocol was 20 mins duration. The target cycling cadance was set at 45 RPM. FES-CG had
electrodes applied to effected limb to quads and hamstrings. The intensity of stim was until a good level of
muscle contraction was visible while maintaining the subject's comfort. The parameters for FES cycling
protocol were the same as the previous study (Chen JJ, 1997 Rehab Eng). Subjects in the CG - 20 mins of
cycling (no FES). Neither group was allowed voluntary cycling.
Postural Control Measurement: used the Limits of Stability protocol for Smart Balance Master System. Pts
were instructed to stand on both legs in a standardized region on the force plate, with their arms held in a
relaxed posture. Move their COG to 8 peripheral targets on a computer screen, as quickly and accurately
as possible within 8 sec. The muscle tone measurement was done with the subjects sitting with the
affected leg straight and ankle in a neutral position to measure the H reflex of the soleus. The H reflex was
elicited by using a single rectangular 1 ms electrical pulse from an electrical stimulator. Two electrodes
were placed on the soleus. A higher H/M ratio indicates higher muscle tone.
The pendulum test was conducted using a electrogoniometer to the effected knee joint. The effected leg
was lifted to max knee extension then dropped until it rested naturally, this was defined as the resting
position. Two successive trials were analyzed. The relaxation index (RI) was defined as the first flexion
angle divided by the 1.6 x (resting position – starting angle). The mean value of RI is one for normal
muscles and a lower RI value represented higher muscle tone.
Statistical significance p < 0.05, The Wilcoxon signed rank test to compare pre- and post test data from
each group. The Mann-Whitney U test was applied to compare the difference between each group.
Results: In the balance test: forward direction was found to have significant interventional effect (MXE p =
.008, and DCL p = .028) in FES-CG. For CG MVL p=. 011, and EPE p =. 022). Backwards direction = no
significant difference between two groups. After cycling training: significant differences for FES-CG: MVL
p=. 028, EPE p=. 032, MXE = .008, and DCL .049; CG = EPE p=. 008, MXE = .005, and DCL =. 017. The
H/M ratio: FES-CG: p = .005; CG group: p = .005. RIs p= .005 and .047 demonstrated significant
difference between pre and post tests. These results show that regardless of FES or no FES reduction of
tone noted.
Critique/Bottom line: Oxford level 2b evidence for increase of postural control with FES assisted cycling
& cycling with or without FES can reduce tone in stroke patients, those with higher muscle tone get greater
benefits with FES added. A 20 minute session of cycling training improved postural control and reduced
tone. Lower quality of study evaluated by PEDro score of 4/10 due to lack of blinding of subjects,
21 therapists and assessors which can increase bias. Many threats to internal and external validity and a
small sample make it difficult to generalize results, but low risk to try intervention.
22 Cycling induced by Electrical Stimulation Improves Motor Recovery in Postacute
Hemiparetic patients. Ambrosini E, Ferrante S, Pedrocchis A, Ferrigno G, Molteni F. Stroke. 2011
Apr;42(4):1068-73.
Oxford Level of evidence: 2b
Pedro Score: 8/10
Purpose: This study assessed whether cycling induced by FES was more effective than passive cycling
with placebo stim in promoting motor recovery and walking ability in postacute hemiparetic patients.
Methods: double blind, CT, clinical trail. n = 35, f/u 22/35 = 63%, but did an intention-to-treat analysis and
analyzed n=30. Placebo group n = 18 having n =15 finishing the study, FES intervention group n =17 with
n = 15 finish the study. Etiology placebo group: ischemic/hemorrhagic/BI = 8/5/2. FES group: 11/3/1.
Subacute stroke < 6 mos: mean: placebo 48 group (36) days, FES group 48 (43) days; Mean age: placebo
56(14) yrs, FES 59(10) yrs.
Placebo group: placebo FES cycling (passive cycling) & intervention group: FES-induced cycling training.
4 week treatment consisted of 20 sessions lasting 25 mins each for 5 times a week. In addition subjects
performed their own standard rehab program for 3 hours a day of PT including stretching, muscular
conditioning, exercises for trunk control, standing and walking training. Seated on a chair in front of a Cycle
ergometer (motomed: Reck GmbH), a current controlled 8-channel stimulator (rehaStim: Hasomed GmbH)
and surface electrodes to quads, hamstrings, glute max, and tibialis anterior of both legs. a bipolar
configuration on quads, hamstrings, glute max, and tib ant., of bilateral legs. Rectangular biphasic pulses
with pulse width of 300 us and stim freq. of 20 Hz were adopted.
For FES group the stim intensity was set on each muscle at a tolerated value producing visibly good
muscle contractions. The stimulation timing was synchronized to the cycling movement accoring to
physiological stereotype activation patterns. All sessions consisted of a 5 min. warm up passive cycling, 15
mins of FES (or placebo), and 5 min. cool down with passive cycling. Pts were required to not pedal
voluntary but instead keep concentrating on the exercise. During passive cylcing the legs were moved
solely by the ergometer's motor, which guaranteed a constant speed of 20 rpms throughout the training
session.
Results: Repeated ANOVA (P<0.05) revealed significant increases in Motricity Index, Trunk Control Test,
Upright motor control test, gait speed and mean work of the paretic leg after training and at follow-up. A
main effect favoring FES-treated patients was demonstrated by repeated-measures ANCOVA for Motricity
Index (P<0.001), Trunk control test (P=0.001), Upright motor control test (P=0.005), and pedaling
unbalance (P=0.038).
Critique/Bottom line: Oxford level 2b evidence that a 4 week FES cycling program improves motor
recovery and walking ability post acute hemiparetic patients. Improvements are maintained for at least 3 to
5 months after the end of treatment. A high PEDro score of 8/10 demonstrating less risk to internal &
external validity and bias. The design had a unique approach to apply stim to both legs compared to most
other studies applying to the involved side only. Also did get follow-up results between 3-5 months post
completion of treatment allows us to determine carry over of treatment. High level of evidence and high
quality trial suggest using this intervention in the clinic.
23 Cycling induced by electrical stimulation improves muscle activation and symmetry
during pedaling in hemiparetic patients. Ambrosini E, Ferrante S, Pedrocchis A, Ferrigno G,
Molteni F. IEEE Trans Neural Syst Rehabil Eng. 2012
Oxford Level of evidence: 2b
Pedro Score: 6/10
Purpose: To Investigate whether improvements in motor function induced by FES-cycling training were
related to changes in muscle strength and EMG activation patterns.
Methods: A double blind, RCT, clinical trail. n = 35 post-acute hemiparesis patients admitted to the
inpatient unit of Villa Veretta Rehab Ctr. f/u 22/35 = 63%, but did an intention-to-treat analysis and
analyzed n=30. Placebo group n = 18 having n =15 finishing the study, FES intervention group n =17 with
n = 15 finish the study. Etiology placebo group: ischemic/hemorrhagic/BI = 8/5/2. FES group: 11/3/1.
Subacute stroke < 6 mos: mean: placebo 48 group (36) days, FES group 48 (43) days; Mean age: placebo
56(14) yrs, FES 59(10) yrs.
Intervention: Placebo group: placebo FES cycling (passive cycling) & intervention group: FES-induced
cycling training. 4 week treatment consisted of 20 sessions lasting 25 mins each for 5 times a week. In
addition subjects performed their own standard rehab program for 3 hours a day of PT including stretching,
muscular conditioning, exercises for trunk control, standing and walking training. Seated on a chair in front
of a Cycle ergometer, a current controlled 8-channel. A bipolar configuration on quads, hamstrings, glute
max, and tib ant., of bilateral legs. Rectangular biphasic pulses with pulse width of 300 us and stim freq. of
20 Hz were adopted. For FES group the stim intensity was set on each muscle at a tolerated value
producing visibly good muscle contractions. The stimulation timing was synchronized to the cycling
movement according to physiological stereotype activation patterns. All sessions consisted of a 5 min.
warm up passive cycling, 15 mins of FES (or placebo), and 5 min. cool down with passive cycling. Pts
were required to not pedal voluntary but instead keep concentrating on the exercise. During passive
cycling the legs were moved solely by the ergometer's motor, which guaranteed a constant speed of 20
rpms throughout the training session. In addition to assigned treatment, subjects performed daily 3 hours
of std rehab program.
Results: A sample of n = 35, f/u 22/35 = 63% f/u rate. Placebo group n = 18 having n =15 finishing the
study, FES intervention group n =17 with n = 15 finish the study. 4 from each group lost at follow-up so only
n=11 assessed for each grouped. They did an intention-to-treat analysis and analyzed n=15 for each. MI
scores: a repeated measures ANCOVA with baseline as covariate showed a sig. time-by-group interaction
in terms of MI scores (p<0.001). Mean differences (95% CI) in favor of FES-treated patients were equal to
19 after training and to 21 at f/u. Gait speed: not statistically significant (p=.037), although gait speed for
FES group was better at post-training and f/u assessment (mean differences 95%CI: 0.10 m/s after
training; .09 at f/u. Pedaling unbalance: repeated measures ANCOVA with baseline as covariate showed a
sig. time-by-group interaction in terms of pedaling unbalance (p=0.04) in favor of the FES group. Post-hoc
analysis revealed a main effect of group in favor of FES-treated patients immediately after treatment
(p=0.03) and while a statistically significant difference between the two groups was not present anymore at
f/u (p=0.07). No significant difference found between groups in terms of works. Although the total work and
work produced during knee extension, were higher for the FES group than for the placebo group, both at
post training and f/u, not statistically significant though. Muscle activation: post hoc analysis revealed a sig.
improvement only between baseline and follow-up scores for CoACT Rectus femoris right vs. left (p<0.01),
24 while sig. changes were found both after training (p=0.012) and at follow-up (p <0.01) in terms of CoAct
Rectus femoris paretic vs. ablebodied.
Critique/Bottom line: Oxford level 2b evidence that a 4 week FES cycling training session applied in the
same manner will improve motor recovery in hemiparetic subjects in the subacute phase. In this study
FES cycling led to an improved motor activation timing of both quadriceps and hamstrings, and a more
symmetrical involvement of the two legs. A strong PEDro score of 6/10, no blinding of subjects, therapists
or assessors assumed and leads to internal validity threat. They did use a commercial FES cycle device
which means it is accessible in the clinical setting.
25 Cycling induced by functional electrical stimulation improves the muscular strength
and the motor control of individuals with post-acute stroke. Ferrante S, Pedrocchi A,
Ferringo G, Molteni F. Eur J Phys Rehabil Med. 2008 Jun;44(2):159-67.
Oxford Level of evidence: 2b
Pedro Score: 6/10
Purpose: The aim of this study was to evaluate the clinical efficacy of FES cycling as a rehabilitation
treatment supplementary to the standard rehabilitation (SR) for sub-acute stroke patients.
Methods: RCT, n = 20; control group n =10 gets SR (56+9.2 yrs old) & time elapsed since ictus
(50.8+24.5 days); intervention group n = 10 (51+12 y/o)&(time since ictus 56.1+22.8 days) gets SR + FES
cycling. 2 groups comparable in age & time since ictus. Intervention: Control group: standard rehab (SR):
performed with therapist: stretching, muscular conditioning with active or passive mobility, exercises to
recover the trunk control, the standing position and walking training. Intervention group: SR as above +
FES cycling for 35 mins: to quads, hamstrings, glute max, tib anterior, bilaterally, per day for 4 weeks.
Speed was maintained at 40 rpms during all trials. both groups underwent about 3 hours treatment per
day, with Standard Rehab. The cyclers did not actively pedal during intervention, no volitional contractions.
Results: Results obtained for 20 subjects for a 100% f/u rate. Control group: TCT: pre-test = 49.0 and
post-test 74.0; MI pre-15.0 and post test 48.0; UMC flex: pre 0.0 and post 1.0; UMC ext. pre 0.0 and post
1.0. FES cycling group: TCT: 43.0 and post 67.5; MI pre=29.0 and post 49.0; UMC flex pre 0.0 and post
1.5; UMC ext pre=.0.0 and post 1.0. The active PO for inter-subjective results obtained during the FES
cycling treatment are difficult to understand, they state they are significantly different from first to last day.
MVC: The MVC for the FES group had a 10 times greater improvement than the control group and this
change for both the paretic leg and healthy leg was significantly different. All the patients in the FES group
recovered the ability to sit to stand and in particular to discriminate between different speed of execution of
the task, All the patients in the control group instead remained still unable to do it after 4 weeks of SR.
%ratio: between the slow and self-selected rising speed obtained for the FES patients was significantly
better than the one obtained by the control group (p = 0.02). 70% of the FES group learned how to perform
the sit to stand with 3 different rising speeds, while no control group learned to perform the task properly.
50m walking test: both groups only had 2 people that could walk 50m pre-test, on post test all 10 of FES
group walked 50m and only 8/10 of the control recovered the ability. There was not significant difference
however between # of steps taken and the walking speed obtained by the 2 groups.
Critique/Bottom line: Oxford level 2b evidence that a 4 week course of SR and FES cycling can
significantly improve muscular strength (10x’s that of the control) and motor recovery (as all the intervention
group could perform the sit to stand task at 3 control speeds where as none of the control group could do
this. PEDro score of 6/10 demonstrates a high quality RCT. It would be helpful to see a follow up analysis
for treatment effect over time, and a larger sample size to be more confident in generalizing this treatment.
I think there is good evidence to use this intervention in the clinic as there is little risk and promising return
on it’s use.
26 Effects of electrical stimulation-assisted cycling training in people with chronic
stroke. Janssen TW, Beltman M, Elich P, Koppe PA, Konihnenbelt H, de Haan A, Gerritis KH. Arch Phys
Med Rehabil 2008;89(3):463-469
Oxford Level of evidence: 2b
Pedro Score: 4/10
Purpose: To evaluate whether leg cycling training in subjects with chronic stroke can improve cycling
performance, aerobic capacity, muscle strength, and functional performance and to determine if electrical
stimulation (ES) to the contralateral (paretic) leg during cycling has additional effects over cycling without
ES.
Methods: RCT, w/partial double-blind design, n=16 outpatients from Rehabilitation Center Amsterdam.
n=4 lost, 3 due to not being able to fit training into their weekly schedule, 1 excluded due to health
problems not related to cycling. N=6 in electrical stimulation-leg cycling exercise (ES-LCE) and n=6 for
control group (LCE). Mean age ES group 54.2+10.7, leg cycling group 55.3+10.4 yrs, type of cva I/H: ES
group = 5/1, leg cycling group = 6/0. Side of lesion L/R: ES group 5/1, leg cycling group 2/4. Time since
stroke: ES group mean 12.3+5.4 mos, control mean 18.3+9.9 mos. Intervention: Trained twice a week for
6 weeks for a total of 12 sessions, due to relatively sedentary patients and needed much time to come to
outpatient setting. The goal was at least 3 bouts, was to achieve 25 to 30 mins of exercise. The target
time was for each bout was 5 to 10 mins, followed by a 5 min rest interval, The resistance was
systematically increased every 2 mins during the exercise bout. The initial level was determined by the pre
GXT. The level was adjusted for each subsequent session by trying to maintain the 5 to 10 min target,
ensuring continuous overload as exercise capabiility increased. Electrical stimulation was applied to
quadricpes, gluteal, and hamstring muscles of involved side only, Stim level was set as high as tolerated.
During each session the highest POpeak (power output) was calculated with a moving average (again
using a 30 second window). The Max exercise intensity of each training was estimated by the highest HR
(HRpeak) during training. expressed as an percent of the individual HR reserve. (HRpeak - resting
HR)/maxHR - restingHR x 100%. The max and resting HR were definded as the highest and lowest levels
measured during all sessions and the GXT.
Results: n=16, 4 lost to follow-up, n = 12, f/u rate of 75%. VO2peak (L/min) significantly increased for the
total group by 13.8%+19.1% (p=.039) The majority of subjects n=9 showed an increase and this increase
was similar for both groups (p=.758); POmax (W) increased in all subjects, with average increase of
38.1%+19.8% (p=.000) and with similar increases for both groups (p=.534); MVC torque contralateral leg
(Nm) not significantly changed p=524; MVC torque ipsilateral leg (Nm) trended to be somewhat increased
(by 9.5%)(p=.151) with no differences between the ES and non ES group (p=.834); BBS the Berg balance
showed improvement in all but 1 subject with ave. increase of 6.9%+5.8% (p=.000) furthermore the score
tended to be larger ES group (10.4% vs. 4.1%), 6MWT (m) the mean difference in the 6MWT was
14.5%+14.1% (p=.035) and this increase was not significant (p=.994), RMI score – remained unaltered
after the training (p=.165)
Significant correlations were found between improvements in VO2max and POmax (r=.91, p=.000) and
between improvements on the 6MWT and the BBS (r=.64, p=0.26).
Critique/Bottom line: Oxford level 2b evidence that 12 sessions of cycling training improved cycling
performance, aerobic capacity, and functional performance in patients with chronic stroke. Low PEDro
27 score of 4/10, a lack of blinding could lead to threats to internal validity, a small subject size means there is
low power, a 75% f/u rate so we have many reasons not to generalize the findings. There was no follow up
to see if there was carry over of effect over time. This was investigating chronic stroke and they did not find
a reason to add the FES to intervention. It would be interesting to see the effects.
28 Effect of a Bout of Leg Cycling with Electrical Stimulation on reduction of hypertonia
in patients with stroke. Yeh C-Y, Tsai K-H, Su F-C, Lo H-C. Arch Phys Med Rehabil. 2010
Nov;91:1731-6.
Oxford Level of evidence: 3, no control group, small power
Pedro Score: not an RCT
Purpose: To evaluate whether a bout of leg cycling in patients with stroke reduces muscle tone and to
determine whether neuromuscular FES to the affected leg during cycling is more effective than cycling
without FES.
Methods: Design: within-subject comparison, n=16, 10 male, 6 female, mean age 54.6+8.3 yrs, time post
stroke 4.4+2.2 weeks, lesion site 10 right, 5 left, lesion type, 7 hemorrhagic, 9 ischemia, recruited from a
university hospital participating in this study, onset of stroke 2 to 8 weeks before the study began.
Intervention: 1) leg cycling with FES & 2) leg cycling no FES. Pretest muscle tone taken 10 min before,
then cycled for 20 mins, then 10 mins after again tone test measures taken. At least 1 day rest, then 2nd
session (opposite of first session) pretest tone 10 mins before, 20 mins cycling (with or w/o FES), and 10
mins after post test measures taken on tone. Stimulation intensity was adjusted by the therapist's visual
observation on an individual basis to elicit muscle contraction without introducing pain. Mean intensities of
the quads and hamstrings were 47.7+5.7 and 52.5+5.2 mA.
Results: All subjects completed both sessions, f/u rate of 100%. Mean speed of assisted- and
nonassisted- cycling: 32.7+8.5 and 32.1+9.1 m/min. No significant difference (p = .629) was found between
groups. Modified Ashworth scale: decreased after both sessions. Statistical analysis show sig. differences
between pre- and posttest of assisted (Z = -3.035; P=.002) and nonassisted sessions (Z=-2.500; P=.012).
The modified Ashworth score decreased from 4 to 2 after assisted, and 4 to 3 in non assisted cycling.
Comparison of change in both intervention values resulted in statistical differences (Z=-2.000; P=.046)
Pendulum Test: significant differences were found between both sessions. Sig. increases in relaxation
index (t=-4.808; P<.001) and peak velocity values (t--5.344; P<.001) in the assisted cycling session. Sig.
increases were present for relaxation index (t=-2.557; P=.022) and peak velocity values (t=-4.492; P<.001)
in the nonassisted-cycling session. Results showed that Changes in relaxation index and peak velocity
values were significantly different P=.021 for relaxation index, P=.035 for peak velocity between both
interventions. Relax index and peak velocity values for the assisted-cycling session were 189% and 197%
higher than the nonassisted session.
Critique/Bottom line: Oxford level 3 evidence that during a single bout of FES cycling or cycling w/o FES
helped to reduce muscle tone of affected leg in subacute stroke patients. Applying FES to the effected leg
was more effective at reducing tone than non FES assisted cycling. This was not a RCT nor did the study
have a control group which are limitations in design. This was over the course of one treatment with no
follow up so they did not investigate for lasting effects. This was a small sample size so there is a lack of
statistical power in the results. This is only moderate level evidence that FES cycling is an effective
intervention for reducing tone in subacute stroke patients. There is low risk of using this intervention to
reduce tone so it would be something that I would try in the clinic.
29 Functional Electrical Stimulation assisted cycling of patients with subacute strokeKinetic and kinematic analysis. Szecsi J, Krewer C, Muller F, Straube A. Clinical Biomechanics.
2008 Oct;23(8):1086-94.
Oxford Level of evidence: 3, it is a cross-sectional study design. A type of quasi-experimental design
without a control.
Pedro Score: not an RCT
Purpose: 1. To determine the quantifiable biomechanical parameters of cycling which FES can improve in
patients with subacute hemiparesis. 2. To explain why patients with hemiparesis are able to improve their
kinematic and kinetic parameters of cycling with the support of FES.
Methods: Cross-sectional study, each participant underwent first static then a dynamic measurement
during one experimental session. N=39, (15f/24m; age; mean 68.7 years (SD 10.9)) with subacute
hemiparesis (mean 10.9 weeks post stroke (SD 5.9)) took part in the study. Severely disabled stroke
patients (Barthel index mean 28.1 (SD 19.0)), mobility = greatly impaired to confined to a w/c, functional
mobility category mean 0.8 (SD 1.1)). Most not able to stand independently. All had mod. increased
muscle tone during knee extension. Sensibility was preserved: but reduced or disturbed in all but 1 subject,
who was completely anesthetic.
Intervention: FES: the quads and hamstrings muscle groups of the affected side were electrically
stimulated during ergometric cycling. For isometric measurements only the affected quads group was
stimulated. Electrodes 4.5 x 9.5 cm sq. were placed on the skin over the proximal and distal fourth of each
muscle bulk. An 8 channel stimulator (motionstim) provided the stim. (rectangular, biphasic, charged
balanced pulses; freq. 20 hz; max pulse amplitude, 127 mA; constant pulse width 300 us). (Glutes nor
contralateral side musculature not FESed).
Results: 0 lost subjects so f/u rates of 100% 39/39. The asymmetry between affected and non-affected
legs in hemiparetic subjects was mean 39% (SD 25, range 0-88%). Voluntary torque generated by affected
mean 21Nm (SD 16) and the non-affected legs (mean 57 Nm (SD27). The electrically evoked torque
amounted to mean of 4.0 Nm (SD 4.1, range 0-13.6 Nm) it was achieved at the max tolerated stim
intensities of mean 60.8 mA (SD 30.0). Sig. correlations were found between the FES evoked and the
maximum of volitional torque generated by the affected as well as the non-affected legs (p=0.01 and
p=0.02). These correlations were moderate (Spearman’s 0.37 and 0.44) Therefore the variance of the
volitional torques could not explain the variance of the electrically evoked torques (that of the affected and
the nonaffected legs amounted to only 16% and 13%). A larger correlation was found between the max
FES torque and the max tolerated stimulation intensity (rs=0.63, p<0.001). The electrically evoked torque
was better explained by the maximal tolerated stimulation intensity (58%) than by the volitional torques.
Ergometric measures: Power: mean for all pooled data: 51 W (SD 21) and 53 W (SD 26) for purely
volitional and combined. The individually measured power sig. increased in only 3 subjects when FES was
added. Smoothness: Pooling of smoothness data shows: roughness in crank speed in only the volitional
contraction decreased from 43.8 (SD 20.4) to 37.6 (SD 16.8) during stim supported volitional contraction.
The mean improvement was change in RI 6.2 (SD 11.7). 10 of 39 (26%) subjects sig. increased
smoothness significantly (p < 0.05) improved with FES (mean 83 mA intensity, SD 27)). While other 29 did
not show sig. change. Sig. improvements generally occurred with the subjects who had larger electrically
evoked torques; 8 of 10 of these subjects generated torques exceeding 5.5 Nm. No sig. improvements
found in 29 subjects. Symmetry: Mean side-related symmetry of the torques amounted to 0.13 (SD 0.11)
30 and 0.18 (SD 0.14) in the case of volitionally and FES stim supported cycling. Change in SI was
correspondingly 0.04 (SD0.15) using FES. Only 4 of 39 subjects sig. (p< 0.05) increased their cycling
symmetry. Dependence of improvement of smoothness (change RI) on electrically evocable torque
(Change Torque). Pooled data analysis of all subjects revealed sig. correlations between the improvement
of smoothness (change RI) of the cycling movement and the electrically evocable isometric torque (change
torque): the Spearmann correlation coefficient was 0.66 with p = 0.001 and statistical power = 0.998. The
corresponding linear regression showed that 70% of the change in RI variance could be explained well by
change in isometric torque variance.
Critique/Bottom line: Oxford level 3 evidence for main effect of FES-assisted cycling in subacute
hemiparesis is an improvement of smoothness of pedaling more than an increase in muscle power. Power
and symmetry were improved in only a small fraction of patients 8 and 10%. This study had many
limitations as there was no control group, it consisted of only a 1 day treatment, and their measuring
system lacked the sophistication of the Chen et al., 2005 study that they compare their work to. The
authors suggest over time a strengthening could occur. RCTs that have followed this date have had better
outcomes which leads me to not hang my hat on this research.
31 Intensive training of subjects with chronic hemiparesis on a motorized cycle
combined with functional electrical stimulation (FES): A feasibility and safety study.
Alon G, Conroy VM, Donner TW. Physiother Res Int. 2011 Jun;16(2):81-91.
Oxford Level of evidence: Level 4, case series design of 10 subjects. This design is good for basis for
future research.
Pedro Score: not an RCT
Purpose: To test if a diverse subjects with chronic stroke could tolerate an intensive training on a
motorized cycle combined with FES system? And to test if selected variables of locomotion will change as
a result of the intense training protocol.
Methods: n =12, case series design, lost 2 for a follow up of n =10 out of 12, 83.3% f/u, rate 1 lost to fall
with injury to shoulder, the other one c/o shortness of breath with training. Chronic strokes: 2 yrs to 37 yrs
post, (only 1 at 37, 2-9 range otherwise. Mean age 59 (SD 13.2), range 36-80 years. Use of lower limb
orthosis: 3=no, 1=KAFO, 2=AFO, 34=A-AFO.
Intervention: FES cycling 3 x's a week for 8 weeks = 24 total training sessions. Muscles stimed: quads,
hamstrings, dorsiflexors and plantar flexors of involved side only. 31 mins 45 secs of FES, included 45 sec
warm up as crank speed increased to 40 rpms (motor only), 30 mins FES at a min of 45 RPM and 1-min.
cool down (motor only) at 35 rpm. Parameters: waveform symmetric biphasic, phase duration 250
microsec, and pulse rate of 50 pulses per second. For intensity: set at beginning, the after 10 mins asked if
they tolerate more and if agreed the researcher increased the intensity of each channel to the pts tolerance.
Changes stored in the pts electronic file.
Results: 10 subjects completed study out of 12, f/u rate of 83.3%. Completed 24 sessions of training. 0
adverse rxns to training or FES. All but 2 pts were able to increase the intensity over time. Group means
for: Stimulus amplitude represent and average of all 4 muscle groups. Each mean was sig. higher
comparing sessions 1, 12, and 24 (p = 0.004). kCal used during each session also increased significantly
(p = 0.0003). Increase in energy consumption: 1~ 2.1, session 12~4.1, and 24 ~7.1 ; Resistance to
pedaling increased sig. (p=0.005) between first session (1 Nm of resistance) and session 12. Session 24
sig. higher than session 12. Mean HR at the beginning of session 1 69.8+11.2 bpm, and rose to 85.2+14.5
at the end of the session. (p = 0.007). HR at the beginning of session 24 (last) was 72.0+11.8, and
reached 101.4+12.4 (p = 0.007). The HR at end of last session was 18.5% higher than at the end of
session 1. Though the difference between HRs between session 1 and 24 were not statistically different.
Peak pedaling power of the lower limbs also increased sig. (p=0.01) after training. GUGO testing:
increased significantly (p = 0.03) and gait velocity (p=0.01) improved sig. after 24 sessions of cycling
training. Two variables of locomotion that did not change significantly were cadance and single limb stance
time on paretic limb. Group mean cadence increased from 61.5+ 26.5 and 65.4 + 30.3 steps per min, and
paretic single limb stance time changed from 0.33 +0.14 to 0.40+ 0.06.
Critique/Bottom line: Oxford level 4 evidence that intensive training on an FES cycle aided chronic stroke
patients to significantly improve GUGO test and gait velocity, as well as peak pedaling power of lower
limbs, and kCal utilized during training. This shows promise but we can’t generalize the findings as this
was implemented on patients 2 to 37 years post stroke. This type of intervention would carry more risk for
a sub acute patient and I would not want to adopt this training protocol due to risk. It does open the door
32 for trying to design a large random control trial looking at the effects for chronic stroke patients with
hemiparesis.
33 Name: Bob Graham___________________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Lo HC, Hsu YC, Hsueh YH, Yeh CY. Cycling exercise with functional electrical stimulation improves postural control in stroke patients. Gait Posture. 2012 Mar;35(3):506-­‐10. Level of Evidence (Oxford scale): 2B, small sample of n=20, Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Yes, the aims of this study were to determine Stated clearly? if a short-­‐term FES-­‐cycling program can Usually stated briefly in abstract and in greater improve the postural control of stroke detail in introduction. May be phrased as a subjects, and to verify that the application of question or hypothesis. FES in cycling programs is more effective than A clear statement helps you determine if topic without such application. is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Relevant backround info has been provided. Literature Cycling has been shown to be beneficial to Relevant background presented? assist with functional gait training in stroke A review of the literature should provide patients. Repetitive passive movements have background for the study by synthesizing been shown to decrease spasticity. FES has relevant information such as previous been shown to improve walking ability in post research and gaps in current knowledge, along stroke patients. FES cycling has been shown to with the clinical importance of the topic. increase muscle strength and endurance, Describe the justification of the need for this cardiopulmonary improvement, bone density study and psychosocial aspects. Does the research design have strong internal validity? Appraisal Criterion  Discuss possible threats to internal validity in the research design. Include: Reader’s Comments Assign: random Attrition: none, immediate follow up test same day History: none, same day 34 Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression 
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Instrumentation: no mention of calibration Maturation: no (no time passed) Testing: follow up balance test might have some learning involved. Compensatory equalization of treatments: no blinding. A protocol was used for FES intervention, therapist set the contraction intensity (difficult to control or possibly not bias this) Compensatory rivalry: subjects not blinded, no sure if subjects were kept separate, it does not say. Statistical regression: looks ok Are the results of this therapeutic trial valid? Appraisal Criterion 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? Reader’s Comments yes No it was blind Yes, they did report, some differences noted, they do not publish a analysis to say if statistical or not. FES-­‐CG n=10 CG n=10 Type of stroke Hem./Ischem. 6/4 5/5 Time since stroke (mos): 25.54+12.95 29.64+10.36 Side of hemiplegia (R/L) 5/5 6/4 35 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 5. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 7. Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 8. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 9. Were all patients analyzed in the groups to which they were The big one here might be the type of stroke ischemic vs. hemorrhagic and how the recovery occurs. Yes, this can lead to a risk of internal validity as the patients might of altered their efforts on testing. Yes, this can lead to a risk of internal validity as well as the therapists might of altered the amount of FES looking for an effect. yes Yes/no, it answers the question in the short term, with a session of cycling or cycling with FES what are the effects on postural control and tone, which is the question they posed. It does not answer if the effect lasts however. Yes, there was no lapse between treatment and follow up the testing happened right after treatment. yes 36 randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Are the valid results of this RCT important? Appraisal Criterion 10. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here Reader’s Comments They used non-­‐parametric due to small sample size. Wilcoxon signed rank test used for between groups at start (correct). Mann-­‐
Whitney U test to compare each group (correct). In the balance test: forward direction were found to have significant interventional effect (MXE p = .008, and DCL p = .028) in FES-­‐CG. For CG MVL p=.011, and EPE p =.022). Backwards direction = no significant difference between two groups. After cycling training: significant differences for FES-­‐CG: MVL p=.028, EPE p=.032, MXE = .008, and DCL .049; CG = EPE p=.008, MXE = .005, and DCL =.017. The H/M ratio: FES-­‐CG: p = .005; CG group: p = .005. RIs p= .005 and .047 demonstrated significant difference between pre and post tests. These results show that regardless of FES or no FES reduction of tone noted. Lower muscle tone group: no significant differences for FES-­‐CG vs. CG in muscle tone reduction. In the higher muscle tone group FES-­‐CG (n=6) and CG (n=7) significant difference between groups concerning their forward cDCL (directional control) (p=.022). Lower muscle tone group no sig. differences in tone reduction between groups for cH/M and cRI. For the higher muscle tone group there was significant difference cH/M (p=.015) but not for cRI (p=.568) • No raw data given, means only. 37 11. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Cycling training decreased tone in stroke patients with hemiplegia with or without FES, but in the group with higher tone there was sig. difference in cH/m reduction and directional control with FES for postural control. It was not brought up and no raw data provided to calculate. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 13. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 16. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? Reader’s Comments Yes, it is available, I believe it is affordable (not sure) in this clinical. It can be worked in as a treatment, depends on the setting if they have an FES bike. Yes, stroke with L hemiplegia, age 40’s Yes, not much risk, pain and discomfort to FES stim due to hypersensitivity. It might reduce tone and increase postural stability which is good. Yes the client liked the treatment and had positive things to say about how it felt. 17. Are there any threats to external validity in this study? Yes, small sample size, also Pedro #1 eligibility criteria clearly stated? No, so this is a threat to external validity as we do not know where these subjects came from. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Reader’s Comments 4/10 [Eligibility criteria: No; Random
38 Summarize your findings and relate this back to clinical significance allocation: Yes; Concealed allocation: No;
Baseline comparability: Yes; Blind
subjects: No; Blind therapists: No; Blind
assessors: No; Adequate follow-up: No;
Intention-to-treat analysis: No; Betweengroup comparisons: Yes; Point estimates
and variability: Yes. Note: Eligibility criteria
item does not contribute to total score]
*This score has been confirmed* A short term bout of cycling training of 20 mins helped improve postural control and reduce tone in patients with hemiplegia in stroke patients that were greater than 1 year out from date of injury. Improving postural control and reducing tone could be beneficial for training in functional mobility during PT sessions. This study did not have a follow up to see if effects carried over in the long term, or if more than 1 session could have greater benefit. 39 Name:_Bob Graham_________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Ambrosini E, Ferrante S, Pedrocchis A, Ferrigno G, Molteni F. Cycling induced by Electrical Stimulation Improves Motor Recovery in Postacute Hemiparetic patients. Stroke. 2011 Apr;42(4):1068-­‐73. Level of Evidence (Oxford scale): 2B, follow up was 62.8% 35 allocated and 22 finished, although they analyzed 30 (15 in each group) but not sure how they did it. Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments This study assessed whether cycling Stated clearly? induced by FES was more effective than Usually stated briefly in abstract and in greater passive cycling with placebo stim in promoting motor recovery and walking detail in introduction. May be phrased as a ability in postacute hemiparetic patients. question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes, past studies show that FES cycling is Literature Relevant background presented? effective in improving muscle strength, cycling A review of the literature should provide smoothness, and peak pedaling power. A key background for the study by synthesizing question is whether FES-­‐mediated training on relevant information such as previous a cycling ergometer translates into improved research and gaps in current knowledge, along outcomes for overground locomotion. with the clinical importance of the topic. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion Reader’s Comments 40  Discuss possible threats to internal validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression Assignment was random Attrition-­‐ there was loss of subjects from 35 down to 22, so internal validity threat. History: a control group was used (a placebo group) Instrumentation: there is no mention of calibration, this is a threat to internal validity. Maturation: not an issue in this study, adults over a 3 to 5 mos window not that big of a deal. Testing: there could be some influence, it does not state they offered multiple learning training sessions prior to testing so the testing might of influenced abilities. Compensatory Equilization: there could be bias here, the therapist providing the FES might of manipulated the degree. Compensatory rivalry: the patients were blinded not an issue. Statistical regression: we don’t have raw data to know if there were outliers, so potential bias. Are the results of this therapeutic trial valid? Appraisal Criterion 18. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 19. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 20. Were the groups similar at the start of Reader’s Comments Yes, a computer generated random allocation was used, with automated assignment system was used to ensure allocation concealment. No, both patients and assessors were unaware of group assignment. Yes they were similar and yes they did report 41 the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 21. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 22. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 23. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 24. Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 25. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this the demographics. There were no significant differences between groups in terms of demographics variables and primary outcome measures prior to the start of the study. The placebo group showed a better score on Trunk Control Test (TCT) prior, although no significant difference was found. No, they were blinded to group assignment as well. Yes, the therapist had to be aware of whether to provide real FES to the patient or a placebo amount. This is a threat to internal validity there could have been an purposeful or non-­‐
purposeful influence on the outcomes by increasing/decreasing the FES levels. Yes, they were either applied the FES or placebo cycling 20 sessions of 25 mins per day and 5 days a week, on top of their rehab program for the same amount of time 3 hours per day. Yes , measures after treatment directly then on a follow-­‐up between 3 to 5 months later. No, 35 were assessed for eligibility and randomized, 30 were assessed at post training (1 femur fx, 1 had a heart attack, 3 discharged). 11 in each group for 22 total were analyzed at follow-­‐up. So 5 lost at finish of treatment, and 13 lost by 42 attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? follow up. This could lead to a threat of internal validity. The fx and heart attack we understand nothing could be done. We don’t know why the others were discharged. Again, there could be biasing here. 26. Were all patients analyzed in the Yes patients were analyzed in the groups into groups to which they were which they were randomized. There was no randomized (i.e. was there an intention to treat analysis provided. This intention to treat analysis)? could lead to biasing of data or inaccurate a. If not, what did the authors do reporting of results. with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Are the valid results of this RCT important? Appraisal Criterion 27. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here 28. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? Reader’s Comments Repeated ANOVA (P<0.05) revelaed significant increases in Motricity Index, Trunk Control Test, Upright motor control test, gait speed and mean work of the paretic leg after training and at follow-­‐up. A main effect favoring FES-­‐
treated patients was demonstrated by repeated-­‐measures ANCOVA for Motricity Index (P<0.001), Trunk control test (P=0.001), Upright motor control test (P=0.005), and pedaling unbalance (P=0.038). No significant differences in walking speed between groups were remarked. A subgroup analysis performed on ischemic stroke patients (n=11, FES group; n=8, placebo group) demonstrated reliably higher gait speed after treatment for FES-­‐treated patients when compared to the placebo group (p=0.014; mean differences based on pooled scores (95% CI), 0.54 m/s [0.12-­‐0.96]. Effect size: The significant improvements of the FES intervention group in the outcome measures of MI, TCT, and UMCT after treatment that were maintained at follow-­‐up. All show 43 29. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? improvements in functional impairments. Gait speed of this group also had a significant improvement after treatment that was maintained after follow-­‐up, where the placebo group did not a significant improvement after treatment but did at follow-­‐up. This shows some evidence that the FES intervention group has a quicker recovery in terms of locomotion. They did mention a MCID set for gait speed of 0.16 m/s with SD of 0.22 m/s. There was no sig. difference between groups in gait speed after tx or at f/u. They did a subgroup analysis on ischemic strokes only n = 11 in FES and n= 8 for placebo group and did find significantly higher gait speed for FES treated patients compared with placebo group (p=0.014; mean difference based on pooled scores [95% CI], 0.54 m/s [0.12 – 0.96]). Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 30. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 31. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 32. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? Reader’s Comments Yes with the proper tools this sounds like a treatment that would be helpful for this population. Yes the subjects fall within similar age ranges, time since injury, and type of stroke. 33. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? Yes, there does not seem to be harm from the therapy if the patient can tolerate the FES, my patient had no orthopedic limitations that would not allow him to cycle. Yes, cycling was accepted as a treatment therapy by my patient and he enjoyed using the therapy. He felt it was helping him progress in his recovery. 34. Are there any threats to external No, adequate sample of 35, clinical trial, 44 validity in this study? seems generalizable to me. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments 8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-­‐up: Yes; Intention-­‐to-­‐treat analysis: No; Between-­‐group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* This was a fairly strong study that seems generalizable to my patient population. The goals of the patient usually include functional outcomes, this study has some strong evidence for improving trunk control, paretic limb function, and tasks in standing as well as gait speed. I feel the results of this study are worth following. 45 Name:_Bob Graham____________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Ambrosini E, Ferrante S, Ferrigno G, Molteni F, Pedrocchi A. Cycling induced by electrical stimulation improves muscle activation and symmetry during pedaling in hemiparetic patients. IEEE Trans Neural Syst Rehabil Eng. 2012 May;20(3):320-­‐30. Level of Evidence (Oxford scale): Level 2B as the follow up rate was 22/35 patients 63% only. Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments To Investigate whether improvements in Stated clearly? motor function induced by FES-­‐cycling training Usually stated briefly in abstract and in greater were related to changes in muscle strength detail in introduction. May be phrased as a and EMG activation patterns. question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? The authors cite 25 studies in the introduction as for the need for the current study. Studies Literature show a decrease in motor units firing in a Relevant background presented? hemiparetic muscle after stroke, that strength A review of the literature should provide training can lead to functional improvements. background for the study by synthesizing It is controversial if improvements in strength relevant information such as previous will lead to improvements in clinical measures research and gaps in current knowledge, along of walking. Motor control and motor learning with the clinical importance of the topic. might play an important role in stroke rehab. Describe the justification of the need for this FES cycling potentially can play a crucial role in study this research. FES can induce both the afferent and efferent pathways which could lead to better outcomes. This current study is important to investigate if there is a link between FES cycling and improved muscle activation and symmetry. 46 Does the research design have strong internal validity? Appraisal Criterion  Discuss possible threats to internal validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression Reader’s Comments Assignment was random allocation Attrition: n=35 with only n=22 finishing the study, there is threat to internal validity with such a small follow up rate. History: there was a control group so not to concerned about history. Instrumentation: no mention of calibration of the tools used, this is a threat to internal validity. Maturation: this was study with subjects mean age of 56 and 59 over a short period of time of 3 to 5 months, I don’t think there is a threat to maturation. Testing: measures of overground walking speed and leg subscale of motricity index (MI) were used as well as mechanical work and muscle activation timing. I don’t feel these tests would lead to a threat to internal validity due to the nature of the tests, hard to imagine that someone learns muscle activation timing, or how to walk from the test these are items that more natural to us. Compensatory equalization of treatments: both groups got standard rehab (SR) and either FES or no FES during the cycling so I don’t think there is a threat to internal validity. Compensatory rivalry: they called this a double blind study but then did not tell us the blind method, PEDRO did not give them credit for the blinding. Both FES and placebo group had electrodes on so potentially they would not know. This is a potential threat to internal validity. Statistical regression: there is not a list of baseline measures for all to determine if their were outliers. The results section does say there were no sig. differences in terms of MI scores, gait speed, mechanical works and pedaling imbalances. Which I believe is 47 referring to the mean of the groups, so there is a potential threat to internal validity. Are the results of this therapeutic trial valid? Appraisal Criterion 35. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 36. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 37. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 38. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 39. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s Reader’s Comments yes Yes, this could lead to bias and skew the results of the treatment effect. Yes, demographics were reported and they stated there was no significant differences between groups in regards to age, time since disease onset, MI scores, gait speed, mechanical works, and pedaling unbalance. Yes, again this could lead to skewing of results, the subjects who did not get treatment might have decided to underperform due to not getting the treatment. Yes, again this can lead to bias as they might of wanted a certain outcome and encourage the treatment group to try harder during testing. 48 results 40. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 41. Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 42. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 43. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Sounds like they were, both groups got standard rehab as well as the cycling with either FES or no FES Yes 3 to 5 mos was a good amount of time. No, only 22 of the 35 finished. 13 were lost. The authors did do an intention to treat analysis and reported the reasons for lost subjects. This again is a threat to the validity of this study as there are some legitimate reasons a subject would be lost but also reasons from study design that they would be lost as well. yes Are the valid results of this RCT important? Appraisal Criterion 44. What were the statistical findings of this study? a. When appropriate use the calculation forms below to Reader’s Comments MI scores: a repeated measures ANCOVA with baseline as covariate showed a sig. time-­‐by-­‐
group interaction in terms of MI scores (p<0.001). Mean differences (95% CI) in 49 b.
c.
d.
e.
f.
determine these values Include: tests of differences With p-­‐values and CI Include effect size with p-­‐
values and CI Include ARR/ABI and RRR/RBI with p-­‐values and CI Include NNT and CI Other stats should be included here 45. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? favore of FES-­‐treated patients were equal to 19 after training and to 21 at f/u. Gait speed: not statistically significant (p=.037), although gait speed for FES group was better at post-­‐
training and f/u assessment (mean differences 95%CI: 0.10 m/s after training; .09 at f/u. Pedaling unbalance: repeated measures ANCOVA with baseline as covariate showed a sig. time-­‐by-­‐group interaction in terms of pedaling unbalance (p=0.04) in favor of the FES group. Post-­‐hoc analysis revealed a main effect of group in favor of FES-­‐treated patients immediately after treatment (p=0.03) and while a statistically significant difference between the two groups was not present anymore at f/u (p=0.07). No significant difference found between groups in terms of works. Although the total work and work produced during knee extension, were higher for the FES group than for the placebo group, both at post training and f/u, not statistically significant though. Muscle activation: post hoc analysis revealed a sig. improvement only between baseline and follow-­‐up scores for CoACT Rectus femoris right vs. left (p<0.01), while sig. changes were found both after training (p=0.012) and at follow-­‐up (p <0.01) in terms of CoAct Rectus femoris paretic vs. ablebodied. After treatment the FES treated group had a more symmetric involvement of the two legs and a significant improvement in terms of muscle activation. This suggests that changes in lower limb motor functions might be related to the relearning of a more physiological motor strategy. There was a sig. effect of treatment in terms of pedaling unbalance with a intervention of FES applied to both sides was able to induce a more symmetric involvement. A sig. effect of the mechanical work by the paretic leg was not found, however, after training the paretic limb could produce 7 Nm in total mechanical work in FES treated, while only 2 Nm in the placebo 50 46. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? group. The timing of healthy leg muscles was similar to that of corresponding muscle in the healthy groups showing that no compensatory strategy was adopted by the stroke patients. After intervention, FES-­‐treated patients sig. improved the activation timing of the paretic muscles (partial recovery of RF and complete recovery of BF), maintained or even furthered at follow up. The unique thing about this study was the biomimetic stimulation strategy of the FES, which might lead to better outcomes. The afferent inputs provided by FES are physiologically synchronized with the cycling movement, theoretically helping the patients in “reminding” how to pedal voluntarily. It does not say. This is an interesting study with some findings that seem applicable to my subject and I would still use the research. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 47. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 48. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 49. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 50. Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? Reader’s Comments I would use this intervention if the clinic already has the FES cycle and 3rd party is willing to pay for it. Yes the age, condition and impairments are similar. I think they do, again there is not a lot of risks to using this intervention with some good potential benefits of increasing the involved leg symmetry and muscle activation. Yes, he enjoyed using the device and stated he felt like it was aiding his recovery. 51 51. Are there any threats to external validity in this study? This was a clinical trial with little threats to external validity. I believe due to a small sample that it is difficult to generalize, they did a power analysis and said they needed 30 subjects which they started with 35 so perhaps there is some generalizability. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-­‐up: Yes; Intention-­‐to-­‐treat analysis: Yes; Between-­‐group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* This study is a Random Control trail in the clinical setting but had poor follow up at only 63%. There was a lot of threats to internal validity and potential bias which leads me to believe that the study holds less weight. There should be some follow up studies to validate the outcomes. There is not a lot of risk to trying the intervention with some potential good gains in muscle activation and increased symmetry between LE limbs which could lead to improvements in functional gains post stroke. I would try this in the clinic and see monitor for outcomes of my own. 52 53 Name:_Bob Graham____________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Ferrante S, Pedrocchi A, Ferringo G, Molteni F. Cycling induced by functional electrical stimulation improves the muscular strength and the motor control of individuals with post-­‐
acute stroke. Eur J Phys Rehabil Med. 2008 Jun;44(2):159-­‐67. Level of Evidence (Oxford scale): Level 2B, underpowered though. Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Yes, to evaluate the clinical efficacy of FES Stated clearly? cycling as a rehab treatment supplementary to Usually stated briefly in abstract and in greater the standard rehabilitation (SR) for sub-­‐acute detail in introduction. May be phrased as a stroke patients. question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes, the author goes into detail discussion of Literature the use of FES and cycling as a means to help Relevant background presented? stroke recovery listing 13 pieces of literature A review of the literature should provide in support of the reason to pursue this study. background for the study by synthesizing There is research showing that FES stimulated relevant information such as previous walking on paretic side only while side lying in research and gaps in current knowledge, along a non reciprocal fashion with improvements in with the clinical importance of the topic. motor recovery post first stroke. Cycling is a Describe the justification of the need for this reciprocal form of exercise that has similarities study kinematic patterns of extension and flexion movements. They hypothesized that during FES cycling the patient can have sensorial bio-­‐
feedback on the symmetry of the movement on the bilateral use of the legs. This leads to their research. Does the research design have strong internal validity? Appraisal Criterion Reader’s Comments 54  Discuss possible threats to internal validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression Assignment was random allocation Attrition: n=16 started and n=12 finished, f/u rate of 75%. History: use of a control group, mean age of about 56 years, and 4 week follow up, = not much risk Instrumentation: there is a threat here, no mention of calibration or reliability testing. Maturation: not much threat here due to the short follow up of 4 weeks and adults mean age of about 56. Testing: There was a pre-­‐test of all 6 items and a post test at end of 20 days of treatment. It does not mention practice, so potentially some learning could of occurred with the first test and improvements seen. This is a threat to internal validity. Compensatory equalization of treatments: no mention of blinding for any groups, this is a threat to internal validity. Compensatory rivalry: no mention of blinding for any groups, this is a threat to internal validity. Statistical regression: this is definitely a threat to In. Validity as there are outliers in their pre-­‐
test measures that were not eliminated nor were repeated baseline measures done. Are the results of this therapeutic trial valid? Appraisal Criterion 52. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 53. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what Reader’s Comments Yes with a computer program Not that I can tell, they were not blinded so there is a threat to internal validity and could result in bias. The investigators could of wanted to see the cyclers do better and 55 are the potential consequences of this knowledge for the study’s results? 54. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 55. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 56. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 57. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 58. Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 59. Did all the subjects originally enrolled adjusted the interventions accordingly. There is a sentence that states the two groups were comparable with respect to demographic and clinical data before treatment. Demographics were reported. Yes, They were not blinded from what I can tell so it sounds like they were knowledgeable of their treatment. The consequence again is that the group not getting the intervention might have been upset and not try as hard on the testing. Yes, again it does not say anything about blinding so we have to assume they know. This could lead to bias and trying to get the intervention group to perform higher on the tests. They both got a standard rehabilitation SR: performed with therapist: stretching, muscular conditioning with active or passive mobility, exercises to recover the trunk control, the stnading position and walking training. It was individually designed however. SO I would say they were not managed equally for control and this could lead to design bias. 4 week follow up is not long enough for looking at long term results. I am not sure we can extrapolate that this intervention will carry over for long term results. yes 56 complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 60. Were all patients analyzed in the Yes, there was no intention to treat analysis groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Are the valid results of this RCT important? Appraisal Criterion 61. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here Reader’s Comments control group: TCT: pre-­‐test = 49.0 and post-­‐
test 74.0; MI pre-­‐15.0 and post test 48.0; UMC flex: pre 0.0 and post 1.0; UMC ext. pre 0.0 and post 1.0. FES cycling group: TCT: 43.0 and post 67.5; MI pre=29.0 and post 49.0; UMC flex pre 0.0 and post 1.5; UMC ext pre=.0.0 and post 1.0. The active PO for inter-­‐subjective results obtained during the FES cycling treatment are difficult to understand, they state they are significantly different from first to last day. MVC: The MVC for the FES group had a 10 times greater improvement than the control group and this change for both the paretic leg and healthy leg was significantly different. All the patients in the FES group recovered the ability to sit to stand and in particular to discriminate between different speed of execution of the task, All the patients in the control group instead remained still unable to do it after 4 57 62. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 63. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? weeks of SR. %ratio: between the slow and self-­‐selected rising speed obtained for the FES patients was significantly better than the one obtained by the control group (p = 0.02). 70% of the FES group learned how to perform the sit to stand with 3 different rising speeds, while no control group learned to perform the tastk properly. 50m walking test: both groups only had 2 people that could walk 50m pre-­‐
test, on post test all 10 of FES group walked 50m and only 8/10 of the control recovered the ability. There was not significant difference however between # of steps taken and the walking speed obtained by the 2 groups. The active max Power output from pre to post test for the FES group was statistically significant. The FES group showed statistical significance for max PO output, as well as a significant increased in muscular strength (10 times greater than the control). The FES had a positive impact on motor recovery: all the FES patients recovered the ability to sit to stand with different speed controls while non of the control group did. All of the FES group could walk the 50m and 8/10 of the control. There was not statistical significant difference between the 2 groups for the TCT, MI or UMC tests. This was not brought up or discussed. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 64. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? Reader’s Comments This study does show some promise for the use of FES cycling for stroke intervention to improve max PO and change in muscular strength of the quadriceps, as well as motor control. The study was small with a total n =20 and under powered. I think I would use 58 this study intervention in my clinic with the appropriate patient if the cycle was available, and it would be covered for the patient. The subjects were similar to my patient with a stroke affecting his left side and having hemiparesis. 65. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 66. Do the potential benefits outweigh Yes, increasing strength in the quads, the potential risks using this increasing max PO and increasing motor intervention with your patient/client? control are all needed for LE recovery after stroke. The only risks I can think of are if the patient was sensitive to the stimulation and could not take the treatment. 67. Does the intervention fit within your Yes he liked this treatment and stated it patient/client’s stated values or helped him in his recovery. expectations? a. If not, what will you do now? 68. Are there any threats to external validity in this study? There are this was a small sample and limits the ability to generalize the outcomes. They have inclusion criteria but they don't say what the source of the subjects is, this can lead to external validity bias. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments 6/10 see below Bottom line: is this study although underpowered does have a high Pedro score of 7/10 and was a RCT so a higher level of evidence. Due to the small sample we are not able to generalize but there is little if any risk to try it with patients of similar characteristics and keep tabs on how effected it is in my clinic. Seeing improvements in muscular strength, max PO, and motor control of the paretic leg is very important for stroke recovery to improve functional outcomes. 59 Name:_Bob Graham____________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Janssen TW, Beltman M, Elich P, Koppe PA, Konihnenbelt H, de Haan A, Gerritis KH. Effects of electrical stimulation-­‐assisted cycling training in people with chronic stroke. Arch Phys Med Rehabil 2008;89(3):463-­‐469 Level of Evidence (Oxford scale): Level 2B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Yes, To evaluate whether leg cycling training in Stated clearly? subjects with chronic stroke can improve Usually stated briefly in abstract and in greater cycling performance, aerobic capacity, muscle detail in introduction. May be phrased as a strength, and functional performance and to question or hypothesis. determine if electrical stimulation (ES) to the A clear statement helps you determine if topic contralateral (paretic) leg during cycling has is important, relevant and of interest to you. additional effects over cycling without ES. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes, Cycling exercise is a method to improve Literature cardiovascular performance in stroke patients. Relevant background presented? Cycling can improve functional mobility. In A review of the literature should provide hemiplegic patients the hemi side might not background for the study by synthesizing be active and muscle atrophy may occur. The relevant information such as previous use of FES might lead to improvements in research and gaps in current knowledge, along cycling performance, aerobic capacity, and with the clinical importance of the topic. functional and muscle performance. Stroke Describe the justification of the need for this patients have limited ability to walk or study exercise to increase HR and improve aerobic capacity, muscle atrophy in the hemi side is often present and functional abilities are decreased. The use of FES cycling might be a way to improve functional outcomes and aerobic capacity. 60 Does the research design have strong internal validity? Appraisal Criterion  Discuss possible threats to internal validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression Reader’s Comments Assignment was random allocation Attrition: n=16 started and n=12 finished, f/u rate of 75%. History: 6 week training time period, probably no issues with history with random assignment. Instrumentation: there is no mention of calibration. Maturation: not an issue 6 weeks for adults is not concerning. Testing: a period of adjustment was given for the cycle ergometer. They used the same testing time frame with breaks in between 6MWT and Berg Balance have been validated, a graded exercise test was used and muscle strength for quads. Compensatory Equalization: they set a std for the amount of FES so no concern here. Compensatory rivalry: patients were blinded from treatment, so no worry. Statistical regression: no raw data to tell if there were outliers, they said there were no significant differences to start with, so we could have a risk to internal validity and bias. Are the results of this therapeutic trial valid? Appraisal Criterion 69. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 70. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences Reader’s Comments Yes They called it a partial double blind study but did not give information about the blinding. Pedro gave them a 4/10 with no credit for any of the blind subjects, blind therapists, or blind assessors. 61 of this knowledge for the study’s results? 71. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 72. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 73. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 74. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 75. Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 76. Did all the subjects originally enrolled Yes there were no significant differences with demographics at the start of the trial. no Yes, they either applied FES to the treatment level or to a low level just to cause some sensation so they knew the difference. There could be some bias and threat to internal validity as the therapists were to set the level of FES to “as high as tolerated” on intervention group, and ES that was not enough to evoke muscle contractions on the control group. Yes, because it was a chronic stroke the only training they got was this protocol, no other training was going on. No, 6 weeks follow up is likely not long enough to see lasting results, there should have been a follow-­‐up out about 6 months or so. We do not know if there is substantial carry over of the training which might be especially important in chronic stroke as if this does not last it is a waste of treatment money and time. No, n = 16 originally enrolled, 12 finished the 62 complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 77. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? study, 3 withdrew due to training not fitting into their schedule and 1 was excluded because of health related problems not related to cycling. This is a f/u rate of 75%. The authors did nothing about this attrition other than list the reasons. The implications are this study had a small n =16 to start with. A f/u rate of 75% is below what we want for level 2 evidence so it reduces the level of evidence. Yes, they kept the groups that they were randomized into the same for all statistical analysis. There was not an intention to treat analysis. There was technical problem and data was lost for 3 outcome measures these were left out of the analysis. Are the valid results of this RCT important? Appraisal Criterion 78. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here Reader’s Comments VO2peak (L/min) significantly increased for the total group by 13.8%+19.1% (p=.039) The majority of subjects n=9 showed an increase and this increase was similar for both groups (p=.758); POmax (W) increased in all subjects, with average increase of 38.1%+19.8% (p=.000) and with similar increases for both groups (p=.534); MVC torque contralateral leg (Nm) not significantly changed p=524; MVC torque ipsilateral leg (Nm) trended to be somewhat increased (by 9.5%)(p=.151) with no differences between the ES and non ES group (p=.834); BBS the Berg balance showed improvement in all but 1 subject with ave. increase of 6.9%+5.8% (p=.000) furthermore the score tended to be larger ES group (10.4% vs. 4.1%), 6MWT (m) the mean difference in the 6MWT was 14.5%+14.1% (p=.035) and this increase was not significant (p=.994), RMI score – remained unaltered after the training 63 79. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 80. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? (p=.165) Significant correlations were found between improvements in VO2max and POmax (r=.91, p=.000) and between improvements in 6MWT and the BBS (r=.64, p=.026). No correlations were found between relative changes in VO2max or POmax and relative changes in BBS and 6MWT. A relatively short cycling training program increased cycling performance, aerobic capacity and functional performance but not voluntary muscle strength in patients with chronic stroke and that ES of the contralateral leg during cycling had no marked additional beneficial effects. It was not discussed. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 81. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 82. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 83. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 84. Does the intervention fit within your patient/client’s stated values or expectations? Reader’s Comments Yes with the proper equipment it could be used, depending on what clinical setting I am in of course. Yes in some ways, the age range, the diagnosis all fit the profile of my patients. However, the time since stroke does not which is a huge difference, my client was sub-­‐acute, and this is for chronic stroke around 1 year for the mean. This study does not show much support for the use of ES while cycling, showing similar results with the control group of cycling with no ES. Again my patient is subacute and this would be more appropriate for that timeframe after stroke. Yes, my patient enjoyed the cycling and was willing to partake in therapies that we thought would help him progress. 64 a. If not, what will you do now? 85. Are there any threats to external validity in this study? Biased sample selection possibly. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments 4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-­‐up: No; Intention-­‐to-­‐treat analysis: No; Between-­‐group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* This study shows cycling for chronic stroke patients helps to improve cycling performance, aerobic capacity and functional performance but not voluntary muscle strength in patients with chronic stroke and that ES of the contralateral leg during cycling had no marked additional beneficial effects. There was a small sample size, lack of control, blinding, and potential bias and potential threats to internal validity, which lowers the level of evidence. 65 Name:_Bob Graham____________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Yeh C-­‐Y, Tsai K-­‐H, Su F-­‐C, Lo H-­‐C. Effect of a bout of leg cycling with electrical stimulation on reduction of hypertonia in patients with stroke. Arch Phys Med Rehabil. 2010 Nov;91:1731-­‐6. Level of Evidence (Oxford scale): Level 3 within-­‐subject design, no control group quasi-­‐experimental. Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Yes it was stated clearly in the abstract. To Stated clearly? evaluate whether a bout of leg cycling in Usually stated briefly in abstract and in greater patients with stroke reduces muscle tone and detail in introduction. May be phrased as a to determine whether neuromuscular FES to question or hypothesis. the affected leg during cycling is more A clear statement helps you determine if topic effective than cycling without FES. is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? 15 past studies were cited in the background Literature presented by the authors. They did a good job Relevant background presented? of explaining the need for this study. A review of the literature should provide Spasticity can affect stroke recovery in a background for the study by synthesizing negative way so finding a method to reduce it relevant information such as previous would be helpful for this patient population. research and gaps in current knowledge, along Patients who have undergone FES cycling have with the clinical importance of the topic. stated their spasticity has decreased. This Describe the justification of the need for this study sought to determine if the repetitive study nature of FES cycling would reduce hypertonia. Does the research design have strong internal validity? Appraisal Criterion  Discuss possible threats to internal Reader’s Comments Assignment was random allocation Attrition: n=20 started and n=20 finished, f/u 66 validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression rate of 100%. The time was only 1 treatment and retest right after. History: no effect due to re-­‐test the same day. Instrumentation: Maturation: not an issue, there was a very short treatment period and average age of subject of 54 y/o. Testing: not an issue, these were not tests that are influenced by learning. Compensatory equalization of treatments: the group received both a FES cycling and non FES cycling intervention. Compensatory rivalry: both groups received both. Statistical regression: does not seem to be a threat to internal validity, although they did not report raw data to verify. Are the results of this therapeutic trial valid? Appraisal Criterion 86. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? Reader’s Comments No this was not a Random controlled trial. All patients received both the FES and no FES on different days to evaluate the effect. This is a within subject design. The consequences are that we do not have a control group to evaluate against to determine if the FES actually made an impact compared to a control group or not. 87. Did the investigators know who was No, they investigator randomly assigned the being assigned to which group prior to subject to one of the interventions on the first the allocation? day, they then would do the other a. If they were not blind, what intervention following by a day. This are the potential consequences of this knowledge for the study’s results? 88. Were the groups similar at the start of 1 group only of n=20 was used for both the trial? Did they report the interventions, so they were similar. demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these 67 differences a threat to the research validity? How might the differences between groups affect the results of the study? 89. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 90. Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 91. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 92. Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 93. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? Yes, because they took part in both an FES assisted and a non assisted they knew which intervention they were getting. This could lead to a threat to internal validity and study bias. No, the therapist who assessed for modified ashworth scale was blinded from pre-­‐ to posttest and to the interventions. Also for the pendulum test. By design they were managed equally as there was only 1 group. Yes for the immediate question if a bout of leg cycling would reduce hypertonia, but it does not answer the a long term question if it could help over a long period. Yes, the follow up was immediate after treatment so all followed up. 68 94. Were all patients analyzed in the They were not randomized so they were groups to which they were analyzed into the group that they started, only randomized (i.e. was there an 1. intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Are the valid results of this RCT important? Appraisal Criterion 95. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here 96. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 97. Do these findings exceed a minimally Reader’s Comments Mean speeds of assisted 32.7+8.5 and nonassisted-­‐cycling exercise 32.1+9.1 m/min, no sig. difference (p=.629) was found between groups. Modified ashworth scale assisted cycling pretest 4 (2-­‐5), and posttest 2(1-­‐4), this is a sig. difference, p = .002. Non assisted cycling 4(2-­‐5), posttest 3(2-­‐5), sig. dif. P=.012. Relaxation index: assisted cycling: pretest: 0.66+0.11, posttest 0.76+0.12, sig. dif. p<.001. Nonassisted-­‐cyling 0.64+0.12 and posttest 0.69+0.12, sig. dif. p=.022. Peak velocity (°/s): assisted cycling: pretest: 353.0+51.7, posttest 409.3+50.3, sig. dif. p<.001. Nonassisted cycling: 347.6+55.5 and posttest 377.8+65.2, sig. dif. p < .001. Results of change between assisted to nonassisted: Modified Ashworth Scale p = .046, Change in relaxation index (%) p = .021, and change in peak velocity (°/s): p= .035 Cycling was effective at reducing tone in this group of subjects and assisted cycling with FES was more effective than non-­‐assisted cycling. What it means for my patient case is that if my patient had tone it would help reduce it, but my patient did not have increased tone. In my practice it suggests that if I have a stroke patient with increased tone and I feel the need to reduce it to increase his ability to treat I could use this strategy. It does not say. 69 important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 98. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 99. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 100.
Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 101.
Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? 102.
Are there any threats to external validity in this study? Reader’s Comments Again this does sound appropriate for use in the clinical setting. Where I am at now there is an FES cycle, if the 3rd party is willing to pay for it it would seem like good tool to reduce tone. Yes, in the same age range and time since stroke, side of stroke and lesion type are all represented. Yes they do, not a lot of risk for this intervention and for someone with increased tone it seems like a good tool to help reduce it. Yes, he enjoyed the use of the cycle and felt it made a positive impact on his recovery. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments It is not a RCT so no Pedro score. The way I interpret this study is if I have a stroke patient that fits in the demographics and has increased tone in the lower extremity it might be worth trying the FES cycling intervention to reduce tone. If I was able to reduce tone to allow me to work on better functional outcomes than this would be worth using. Again there does not seem to be much risk for the patient with potential benefit in 70 reducing tone which could aid therapy and possibly reduce secondary complications of high tone like pressure sores 71 Name:_Bob Graham____________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Szecsi J, Krewer C, Muller F, Straube A. Functional Electrical Stimulation assisted cycling of patients with subacute stroke-­‐ Kinetic and kinematic analysis. Clinical Biomechanics. 2008 Oct;23(8):1086-­‐94. Level of Evidence (Oxford scale): Level 3, it is a cross-­‐sectional study design. A type of quasi-­‐experimental design without a control. Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments 1. To determine the quantifiable Stated clearly? biomechanical parameters of cycling which Usually stated briefly in abstract and in greater FES can improve in patients with subacute detail in introduction. May be phrased as a hemiparesis. 2. To explain why patients with question or hypothesis. hemiparesis are able to improve their A clear statement helps you determine if topic kinematic and kinetic parameters of cycling is important, relevant and of interest to you. with the support of FES. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes the authors do a nice job of presenting Literature background information that is relevant to Relevant background presented? their area of investigation with citations from A review of the literature should provide about 22 previous studies. The use of FES background for the study by synthesizing cycling during the early phase of rehab relevant information such as previous facilitates the achievement of better research and gaps in current knowledge, along functional output in a shorter period of time. with the clinical importance of the topic. Evidence of cycling aiding the recovery of Describe the justification of the need for this walking ability in patients with hemiplegia to study help develop timing and reciprocal force. Does the research design have strong internal validity? Appraisal Criterion Reader’s Comments 72  Discuss possible threats to internal validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression Assignment: not Random this is not a RCT it is a cross-­‐sectional study. Attrition: non lost 1 day intervention and testing/retest History: no threat here same day testing. Instrumentation: They calibrated the testing of the cycle. Testing: they gave the subject 2 mins of warm-­‐
up to get used to it. Compensatory equalization of treatments: no threat, all treated the same way. Compensatory rivalry: again all got the same treatments so no threat. Statistical regression: there is not an analysis of before treatment differences, I think there is threat of outliers influencing here from the data provided. Are the results of this therapeutic trial valid? Appraisal Criterion 103.
Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 104.
Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? 105.
Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these Reader’s Comments No this was not a RCT all subjects received the FES intervention. All subjects did a static and then a dynamic measurement during one experimental session. Without a control group we can’t be certain that the intervention is solely responsible for the outcomes. This is a threat to internal validity. Yes, there is no blinding of investigators that I can tell. There was only 1 group so I don’t think it influences bias all that much as there was no “selecting” a patient for a desired quality. Only 1 group, similar. 73 differences a threat to the research validity? How might the differences between groups affect the results of the study? 106.
Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 107.
Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 108.
Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 109.
Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 110.
Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? Yes, they participated in both aspects of FES and non FES so no consequences. Yes, no mention of blinding. The could lead to bias. Yes. yes Yes, it looks like they did all measurements on the same day. 74 111.
Were all patients analyzed in There was no randomization, they were all the groups to which they were analyzed in one group. randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Are the valid results of this RCT important? Appraisal Criterion 112.
What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here Reader’s Comments 26% of subjects significantly improved the smoothness of cycling with FES. Only 8% and 10% significantly increased their power and symmetry, respectively. The improvement in smoothness significantly correlated with the capability of the individual to generate electrical torque (Spearman’s rank correlation coefficient = 0.66 at p=0.001) The asymmetry between affected and non-­‐
affected legs in hmeiparetic subjects was mean 39% (SD 25, range 0-­‐88%). Voluntary torque generated by affected mean 21Nm (SD 16) and the non-­‐affected legs (mean 57 Nm (SD27). The electrically evoked torque amounted to mean of 4.0 Nm (SD 4.1, range 0-­‐
13.6 Nm) it was achieved at the max tolerated stim intensities of mean 60.8 mA (SD 30.0). Sig. correlations were found betwen the FES evoked and the maximum of volitional torque getneraed by the affected as well as the non-­‐
affected legs (p=0.01 and p=0.02). These correlations were moderate (SPearman's 0.37 and 0.44) There fore the varance of the volitional torques could not explain the variance of the electrically evked torques (that of the affecte d and the nonaffected legs amounted to only 16% and 13%). A larger correlation was found between the max FES torque and the max tolerated stimulation 75 intensity (rs=0.63, p<0.001). The electrically evoked torque was better explained by the maximal tolerated stimulation intensity (58%) than by the volitional torques. Ergometric measures: Power: mean for all pooled data: 51 W (SD 21) and 53 W (SD 26) for purely volitional and combined. The individually measrued power sig. increased in only 3 subjects when FES was added. Smoothness: Pooling of smoothness data shows: roughness in cracnk speed in only the volitaionl contraction decreased from 43.8 (SD 20.4) to 37.6 (SD 16.8) during stim supported volitional contraction. THe mean improvement was change in RI 6.2 (SD 11.7). 10 of 39 (26%) subjects sig. increased smoothness significantly (p < 0.05) improved with FES (mean 83 mA intensity, SD 27)). while other 29 did not show sig. change. Sig. improvements generally occured with the subjects who had larger electrically evoked torques; 8 of 10 of these subjects generated torgques exceeding 5.5 Nm. No sig. improvements found in 29 subjects. Symmetry: Mean side-­‐related symmetry of the torques amounted to 0.13 (SD 0.11) and 0.18 (SD 0.14) in the case of volitionally andFES stim suppported cycling. Change in SI was correspondinly 0.04 (SD0.15) using FES. ONly 4 of 39 sujbets sig. (p< 0.05) increased their cycling symmetry. Dependence of improvement of smoothness (change RI) on electrically evokable torque (Change Torque). Pooled data analysis of all subjects revealed sig. correlations between the improvement of smoothness (change RI) of the cycling movement and the lectrically evokable isometric torque (change torque): the spearman cor. coef. 0.66 with p=0.001 and stat. power =0.998. Linear regression = 70% of the change RI variance could be explained well by change in Torque. If only the 10 subjects with sig. improvement analyzed for correlation and regression then spearman = 0.94 (p=0.001 76 113.
What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 114.
Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? and stat. power 0.995). The explainable variance then =94%. The smoothness of cycling was the most sensitive parameter improved by FES. The smoothness depended on the amount of torque evoked, and the torque achieved, in turn, correlated with the tolerated intensity of stimulation. This study showed that smoothness of cycling movements is the most sensitive and suitable parameter that could be influenced in patients with hemiplegia. Power and symmetry were improved in only a small fraction of patients 8 and 10%. There our data does not confirm the more optimistic predictions in the literature (Chen et al., 2006; Ferrante et al., 2006) about the biomechanical efficacy of FES cycling in hemiplegic subjects. The reason might be that these studies relied on partly a few patients with hemiplegia and partly on patients with chronic hemiparesis. The largest published study (Chen 2005) investigated volitional cycling of 13 patients (mean time since stroke was 25 mos (SD 19). Our study included only pts with subacute stroke (mean time since stroke 10.9 weeks (SD 5.9) They are an important target group for the proposed therapy. Our kinetic analysis of cycling showed less symmetry in volitional cycling (mean SI 0.13 (SD 0.11)) than observed by others (Chen et al., 2005). They do not discuss this, I don’t believe they do as it is not a RCT that can generalize. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion Reader’s Comments 115.
Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 77 3rd party coverage to provide this treatment? 116.
Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? According to this study only ¼ of patients will benefit from this therapy. If the patient fits the inclusion/exclusion criteria and can tolerate higher levels of electrical stimulation than it might be appropriate. My subject is similar to this study, similar age range, dx, subacute stroke. 117.
Do the potential benefits They do not mention any risks to the use of outweigh the potential risks using this FES cycling so I feel it is appropriate to use. intervention with your patient/client? 118.
Does the intervention fit Yes. within your patient/client’s stated values or expectations? a. If not, what will you do now? 119.
Are there any threats to external validity in this study? Yes there is no control group, it is a small sample (Although bigger then the others), What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments Not a RCT The authors bring up some great points about how their findings disputes some of the other studies findings, not seeing the same results in Power increases. This is a subacute sample population and some of the other studies are looking at stroke subjects with mean time since stroke of 25 months, while there study looks at mean time since stroke of 10.9 weeks. This is a lower level of evidence but has more subjects than the RCT so potential for more bias and threats to internal validity. Smoothness of cycling would still be beneficial for many stroke patients to help to increase function, with more than a one day treatment there is potential for long term strength gains as well. I believe there still is evidence to support the use of FES cycling in stroke rehab. 78 79 Name:_Bob Graham____________ Intervention – Evidence Appraisal Worksheet Citation (use AMA or APA format): Alon G, Conroy VM, Donner TW. Intensive training of subjects with chronic hemiparesis on a motorized cycle combined with functional electrical stimulation (FES): A feasibility and safety study. Physiother Res Int. 2011 Jun;16(2):81-­‐91. Level of Evidence (Oxford scale): Level 4, case series design of 10 subjects. This design is good for basis for future research. Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Reader’s Comments Yes. To test if a diverse subjects with chronic Stated clearly? stroke could tolerate an intensive training on a Usually stated briefly in abstract and in greater motorized cycle combined with FES system? detail in introduction. May be phrased as a And to test if selected variables of locomotion question or hypothesis. will change as a result of the intense training A clear statement helps you determine if topic protocol. is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes, the authors cited 27 articles in regards to Literature stroke impairments in walking, FES use in Relevant background presented? stroke recovery, past FES cycling studies and A review of the literature should provide outcomes and how these all lead to the need background for the study by synthesizing for further investigation of FES cycling in relevant information such as previous regards to stroke recovery. research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Does the research design have strong internal validity? Appraisal Criterion  Discuss possible threats to internal Reader’s Comments Assignment was not random, this was not a RCT it is a case series so all subjects got the 80 validity in the research design. Include:  Assignment  Attrition  History  Instrumentation  Maturation  Testing  Compensatory Equalization of treatments  Compensatory rivalry  Statistical Regression intervention. Attrition: n=12 started and n=10 finished, f/u rate of 83.333%. 2 lost due, 1 due to Shortness of breath, and 1 from a fall at home that hurt their shoulder. History: threat to internal validity, no control, over 8 weeks, potential influence of history, creating bias. Instrumentation: RT300, Gaitrite, GUGO tests using video analysis, but no mention of calibration, so threat to internal validity. Maturation: I think threat is low due to adults 36 and older over 8 week period, likely not a great deal of change. Testing: not a threat, tested at baseline, 12 & 24 weeks during training. Compensatory equalization of treatments: there was no control in this group, all treatment was tailored to the patient, I don’t think there was threat here. Compensatory rivalry: not different groups all received same treatment, no threat. Statistical regression: no raw data to compare if there were outliers, potential threat to IV and bias. Are the results of this therapeutic trial valid? Appraisal Criterion 120.
Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study’s results? 121.
Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study’s results? Reader’s Comments No, not a RCT, subjects were recruited by phone through a registry of stroke survivors. The investigators potentially have selected for characteristics to improve outcomes, creating bias. No groups, all in the treatment group so yes. Again this is a threat to internal validity creating bias. 81 122.
Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar – what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 123.
Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 124.
Did the investigators know to which treatment group subjects were assigned ? a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results 125.
Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study’s results? 126.
Was the subject follow-­‐up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study’s results? 127.
Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the No comparison done on the data, there is an outlier in time since stroke, with one at 37 years, otherwise the range is 2 – 9 yrs post stroke. Potential for bias. Yes, all subjects did same protocol, no blinding Yes, all subjects did same protocol, no blinding Yes although individual adjustment for the FES levels, potential differenc. Good times of baseline, session 12 and 24 so 4 and 8 weeks. No 10 out of 12 for a f/u rate of 83.3%, 1 dropped out due to fall injuring shoulder (not related to treatment), and 1 due to SOB with training. This is an ok f/u rate. 82 authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study’s findings? 128.
Were all patients analyzed in Looks like it. the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study’s results? Are the valid results of this RCT important? Appraisal Criterion 129.
What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-­‐values and CI c. Include effect size with p-­‐
values and CI d. Include ARR/ABI and RRR/RBI with p-­‐values and CI e. Include NNT and CI f. Other stats should be included here Reader’s Comments all 10 subs. Completed 24 sessions of training. 0 adverse rxns to training or FES. All but 2 pts were able to increase the intensity over time. Group means for: Stimulus amplitude represent and average of all 4 muscle groups. Each mean was sig. higher comparing sessions 1, 12, and 24 (p = 0.004). kCal used during each session also increased significantly (p = 0.0003). Increase in energy consumption: 1~ 2.1, session 12~4.1, and 24 ~7.1 ; Resistance to pedaling incrased sig. (p=0.005) between first session (1 Nm of resistance) and session 12. Session 24 sig. higher than session 12. MEan HR at the beginning of session 1 69.8+11.2 bpm, and rose to 85.2+14.5 at the end of the session. (p = 0.007). HR at the beginning of session 24 (last) was 72.0+11.8, and reached 101.4+12.4 (p = 0.007). The HR at end of last session was 18.5% higher than at the end of session 1. Though the difference between HRs between session 1 and 24 were not statistically different. Peak pedaling pwer of the lower limbs also increased sig. (p=0.01) after training. GUGO testing: increased 83 significantly (p = 0.03) and gait velocity (p=0.01) improved sig. afetr 24 sessions of cycling training. Two variables of locomoation that did not change significantly were cadance and single limb stance time on paretic limb. Group mean cadence increased from 61.5+ 26.5 and 65.4 + 30.3 steps per min, and paretic single limb stance time changed from 0.33 +0.14 to 0.40+ 0.06. 130.
What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice? 131.
Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Time to complete the GUGO test and gait
velocity increased significantly, mean HR
increases by 18%, Peak pedaling power
of lower limbs also increased
significantly. kCal utilized during training
increased sig., Resistance to pedaling
increased sig.,
Does not say, not brought up or discussed. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 132.
Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment? 133.
Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 134.
Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 135.
Does the intervention fit within your patient/client’s stated values or expectations? a. If not, what will you do now? Reader’s Comments This had good functional outcome increases noted, not all but some of them, gait speed and GUGO test, so it sounds like a good intervention to use, although low level evidence with a lot of potential threat to internal validity. In age yes, but time from original injury no. You could still try the intervention but with a subacute stroke the when they are ready for this treatment might be a factor and change outcomes. This shows promise but we can’t generalize the findings too much, we have to be careful utilizing this training protocol as it would carry risk to the patient as it is fairly intensive. yes 84 136.
Are there any threats to external validity in this study? Potential for threat to external validity as no random sample, selection bias could of occurred, hard to generalize this out of this study. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Summarize your findings and relate this back to clinical significance Reader’s Comments No an RCT. Again I think this intervention could be used due to low risk to the patient and that it fits into his accepted forms of intervention, this is low level evidence with potential for bias, so I might be hesitant to use based off of this. 85 Table 2. Results/Article Summaries Study # & origin Oxford level of evidence PEDro score 1 Lo HC, 2b 4/10 2 Ambro
2b 8/10 3 Ambro
2b 6/10 et al. (2012) Taiwan sini E, et al. (2011) Italy sini E, et al. (2012) Italy Purpose of study To determine if a short-­‐term FES-­‐cycling program can improve the postural control of stroke subjects, and to verify that the application of FES in cycling programs is more effective than without such application. This study assessed whether cycling induced by FES was more effective than passive cycling with placebo stim in promoting motor recovery and walking ability in postacute hemiparetic patients. Outcome measures -­‐Balance test -­‐Hoffman’s Reflex/motor response ratio (H/M ratio) test -­‐Pendulum test, to quantify the muscle tone Answer to Results clinical question -­‐balance test: forward direction were found to yes have significant interventional effect. -­‐The H/M ratio: FES-­‐CG: p = .005; CG group: p = .005. -­‐Pendulum Test: RIs p= .005 and .047 demonstrated significant difference between pre and post tests -­‐Primary: leg subscale of the -­‐Repeated ANOVA (P<0.05) revealed significant yes increases in Motricity Index, Trunk Control Test, Upright motor control test, gait speed and mean work of the paretic leg after training and at follow-­‐up. -­‐A main effect favoring FES-­‐treated patients was demonstrated by repeated-­‐measures ANCOVA for Motricity Index (P<0.001), Trunk control test (P=0.001), Upright motor control test (P=0.005), and pedaling unbalance (P=0.038). -­‐leg s
ubscale o
f t
he m
otricity To Investigate whether -­‐ MI scores: showed a sig. time-­‐by-­‐group yes index (MI), improvements in motor interaction in terms of MI scores (p<0.001). -­‐gait speed timed over a 50 function induced by FES-­‐
Mean differences (95% CI) in favor of FES-­‐
m walk; cycling training were related -­‐EMG activity of Rectus treated patients were equal to 19 after training to changes in muscle and to 21 at f/u. femoris and biceps femoris, and strength and EMG activation -­‐ Gait speed: not statistically significant -­‐mechanical w
ork p
roduced patterns. (p=.037) by each leg during voluntary -­‐ Pedaling unbalance: showed a sig. time-­‐by-­‐
cycling. group interaction in terms of pedaling unbalance (p=0.04) in favor of the FES group. -­‐ Muscle activation: significant changes were Morticity Index -­‐Gait speed during a 50-­‐
meter walking test. -­‐Secondary: Trunk control test -­‐Upright Motor Control Test -­‐
mean work produced by paretic leg, -­‐unbalance paretic vs non-­‐
paretic 18 Table 2. Results/Article Summaries 4 Ferrant 2b 6/10 5 Jansse
2b 4/10 6 Yeh C-­‐
3 Not RCT e S, et al. (2008) Italy n TW, et al. (2008) Nether
lands U, et al. (2010) found both after training (p=0.012) and at follow-­‐up (p <0.01) in terms of CoAct Rectus femoris paretic vs. able-­‐bodied. The aim of this study was to -­‐max isometric -­‐ The MVC for the FES group had a 10x greater evaluate the clinical efficacy voluntary contraction improvement than the control group and this of FES cycling as a (MVC) of quads change for both the paretic leg and healthy leg rehabilitation treatment -­‐walking test of 50 m was significantly different. supplementary to the -­‐sit-­‐to-­‐stand ability -­‐70% of the FES group learned how to perform standard rehabilitation (SR) -­‐motricity index the sit to stand with 3 different rising speeds, for sub-­‐acute stroke -­‐upright motor control while no control group learned to perform the patients. -­‐ test task properly. -­‐trunk control test -­‐50m walking test: both groups only had 2 people that could walk 50m pre-­‐test, on post test all 10 of FES group walked 50m and only 8/10 of the control recovered the ability. -­‐VO2peak (L/min) To evaluate whether leg -­‐ VO2peak (L/min) significantly increased for -­‐POmax (
W) cycling training in subjects the total group by 13.8%+19.1% (p=.039) -­‐MVC torque contralateral with chronic stroke can -­‐ POmax (W) increased in all subjects, with ave. leg (Nm) -­‐MVC torque improve cycling increase of 38.1%+19.8% (p=.000 ipsilateral leg (Nm) performance, aerobic -­‐ MVC torque contralateral leg (Nm) not -­‐BBS -­‐6MWT (
m) capacity, muscle strength, significantly changed p=524 and functional performance -­‐RMI score -­‐ MVC torque ipsilateral leg (Nm) trended to be -­‐Changes in aerobic capacity and to determine if electrical -­‐maximal power output, somewhat increased (by 9.5%)(p=.151) with no stimulation (ES) to the differences between the ES and non ES group -­‐functional performance contralateral (paretic) leg -­‐lower limb muscle strength -­‐ BBS showed improvement in all but 1 subject during cycling has additional with ave. increase of 6.9%+5.8% (p=.000) effects over cycling without -­‐ the mean difference in the 6MWT was ES. 14.5%+14.1% (p=.035) and this increase was not significant (p=.994) -­‐RMI score – remained unaltered after the training (p=.165) -­‐Modified A
shworth s
cale f
or To evaluate whether a bout -­‐Modified Ashworth scale: decreased after spasticity, of leg cycling in patients with both sessions. Statistical analysis show sig. -­‐Pendulumn Test for stroke reduces muscle tone relaxation index (RI) and differences between pre-­‐ and posttest of yes ? yes it answere
d that there was no significa
nt benefit for FES addition 19 Table 2. Results/Article Summaries Taiwan and to determine whether neuromuscular FES to the affected leg during cycling is more effective than cycling without FES. 7 Szecis 3 Not To determine the J, et al. RCT quantifiable biomechanical (2008) parameters of cycling which Germa
FES can improve in patients ny with subacute hemiparesis. To explain why patients with hemiparesis are able to improve their kinematic and kinetic parameters of cycling with the support of FES. To test if a diverse subjects 8 Alon G, 4 Not et al. with chronic stroke could RCT (2011) tolerate an intensive US training on a motorized cycle combined with FES system? And to test if selected variables of locomotion will change as a result of the intense training protocol. peak velocity assisted (Z = -­‐3.035; P=.002) and nonassisted sessions (Z=-­‐2.500; P=.012). -­‐ Pendulum Test: significant differences were found between both sessions with assisted cycling and non assisted cycling. -­‐voluntary torgue generated -­‐smoothness of cycling movements is the most by affected and non-­‐affected sensitive and suitable parameter that could be leg influenced in patients with hemiplegia -­‐Power -­‐Power and symmetry were improved in only a -­‐smoothness small fraction of patients 8 and 10%. -­‐symmetry of cycling -­‐stimulation intensity (uc) -­‐pedaling energy utilization (kcal) -­‐Resistance to pedaling (Nm) -­‐Heart rate (beats/min) % of age adjusted max heart rate -­‐peak pedaling power (W) -­‐Get up and Go time (seconds) -­‐Gait velocity (m/sec) using gait rite -­‐ Stimulus amplitude mean was sig. higher comparing sessions 1, 12, and 24 (p = 0.004) -­‐ kCal used during each session also increased significantly -­‐ Resistance to pedaling increased significantly -­‐ The difference between HRs between session 1 and 24 were not statistically different -­‐ Peak pedaling power of the lower limbs also increased sig. (p=0.01) after training -­‐ GUGO testing: increased significantly -­‐ gait velocity (p=0.01) improved significantly yes 20