928
Original Contributions
The Significance of Intensity of Rehabilitation of Stroke —
A Controlled Trial
JUHANI SIVENIUS, M . D . , * KALEVI PYORALA, M . D . , t OLLI P. HEINONEN, M . D . , t JUKKA T. SALONEN, M . D . , §
AND PAAVO RIEKKINEN, M . D . *
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SUMMARY Of the 373 stroke patients 95 were admitted to the feasibility study of stroke rehabilitation.
The patients were divided into two groups, an intensive and a normal treatment group. In this study, the
functional recovery of stroke, measured by ADL and motor function was significantly better in the intensive
treatment group. There was no difference in institutionalization or incidence of death between the groups.
The gain of ADL and motor function was greatest during the first three months after stroke in the
intensive treatment group. The conclusion is that intensified physiotherapy seems to improve the functional
recovery of stroke patients.
Stroke Vol 16, No 6, 1985
INTENSIVE REHABILITATION as a tool to reduce
disability and dependency has been criticized on the
basis that much of the return could be attributed to
spontaneous recovery. '~2 Lehmann et al3 showed that
significant permanent functional gains could be made
in a rehabilitation center in patients admitted even a
year after the onset of stroke. It could be assumed that
the improvement was not solely due to spontaneous
recovery.
Garraway et al4 compared the management of elderly patients with acute stroke randomized to a stroke
unit or to medical units. A significantly higher proportion of patients discharged from the stroke unit were
assessed as independent compared with patients discharged from the medical units. In the follow-up to this
study5 the difference in functional outcome had disappeared after a year, however.
Smith et al6 allocated stroke patients at random to
one of three different courses of outpatient rehabilitation. Improvement was greatest in those receiving intensive treatment and least in those receiving no routine treatment.
Wood-Dauphinee et al7 examined the effect of interdisciplinary team care versus traditional care in a randomized controlled trial. For motor performance and
functional abilities, male survivors performed better
with team care. Female survivors performed better
with the traditional method for motor performance,
whereas in terms of functional abilities there was no
difference in women between the treatment groups.
This paper compares the effectiveness of two intensities of physiotherapy attempting to assess its importance in stroke rehabilitation.
From the Departments of Neurology* and Medicine,t University
Hospital of Kuopio; the National Public Health Institute, Helsinki;t and
the Research Institute of Public Health,§ University of Kuopio.
Address correspondence to: Juhani Sivenius, M.D., Department of
Neurology, University Hospital of Kuopio, SF-70210 Kuopio, Finland.
Received September 27, 1984; revision # 1 accepted March 15,
1985.
Patients
The Department of Neurology at the University of
Kuopio started a stroke register for the Kuopio area in
east central Finland on October 1st, 1978, and it operated until May 31st, 1980. During that time period 373
stroke patients were found.
After the stroke, all patients were candidates of the
rehabilitation study. At one week the following criteria
were used in excluding patients from this study:
(1) Patient had SAH.
(2) Patient did not have hemiparesis or it was very
mild, patient did not need any help from others.
(3) Prior to the stroke, the patient was already bedridden or dependent on others.
(4) Because of a previous stroke, the disability after
this new stroke was impossible to measure.
(5) Malignant disease, because of which the benefit
of rehabilitation would be short. Malignant disease
was defined as "moribund" patients with advanced
cancer or severe organic insufficiency (heart, kidney,
liver).
(6) Previous psychiatric disease, which would not
allow effective rehabilitation.
(7) The patient was unconscious (in coma or semicoma).
(8) The patient had not been seen by the study physician during the first week after the onset of the stroke.
A total of 95 patients were included into the study.
The patients were then randomized using sealed envelopes at one week's initial registration into an intensive
treatment and a normal treatment group (IT and NT).
The distribution of the diagnosis of the patients was:
brain infarction 89% and intracerebral haemorrhage
(ICH) 11%. The mean ages of the patients in IT and
NT were 71.5 ± 10.5 (SD) and 70.1 ± 9.1, respectively. 17% of the patients had had a previous stroke.
The distribution of working capacity, sex and living
conditions in the two groups were similar (table 1).
There was no statistically significant difference between study groups relative to vascular disease (pre-
INTENSITY OF STROKE REHABILITATION/5ive/i/«i et al
TABLE 1 Sex, Type of Stroke, Living Conditions, Working Capacity and Cardiovascular Diseases in the History of Patients in the
Intensive and Normal Treatment Groups
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Sex*
male
female
Living conditions*
alone
with spouse or family
Working capacity*
engaged in work
sick-leave or retired
Type of stroke*
brain infarction
ICH
Diabetes*
Previous stroke*
Myocardial infarction*
Angina pectoris*
Cardiac failure*
Hypertonia*
Intensive
(%)
No
Normal
Treatment
(%)
No
18
32
(36)
(64)
18
27
(40)
(60)
15
35
(30)
(70)
14
31
(31)
(69)
9
41
(18)
(82)
3
42
(7)
(93)
43
7
7
6
13
17
25
20
(86)
(14)
(14)
(12)
(26)
(34)
(50)
(40)
41
4
8
11
11
24
27
21
(91)
(9)
(18)
(24)
(24)
(53)
(60)
(47)
*n.s., p > 0.05.
vious stroke, myocardial infarction, angina pectoris,
cardiac failure and hypertonia) and diabetes mellitus.
Methods
Methods Measuring Functional Recovery
The technique for assessment of ADL and ambulation described by Lehmann et al3 was modified by the
authors. The following eight activities were assessed:
self-feeding, dressing, bowel and bladder control,
walking, bathing, toilet transfers and rising from a
sitting position. A four point scale was used for all
activities other than walking and bladder and bowel
control as follows:
(1) Totally in need of help.
(2) Marked need for help.
(3) Special equipment of devices are essential,
needs only a little help from others.
(4) Performs without aid of special equipment or
help from others.
The maximum ADL score was 27. The interviews
and observations were made by the study nurse or by
physiotherapists who were specially trained and supervised. The physiotherapist who was responsible for
measuring outcome, acted independently and was not
involved in treating the patients.
A test of range of motion and strength was used to
define the severity of neuromuscular disability and the
presence or absence of neuromuscular recovery. In
these tests, formulated by Katz and Ford, 8 the patient
was asked to perform a series of seven manoeuvres
with the upper limb and five with the lower limb on the
929
affected side. All manoeuvres were tested using defined positions for evaluating motion.
Each movement was assessed with patients in a supine position, as first demonstrated by the examiner.
Every manoeuvre was scored with a 4-point scale as
follows:
(1) No movement at all.
(2) Only a little movement.
(3) Partial movement.
(4) Full movement.
Treatment of Patients in the Study and Measuring
the Amount of Therapy
The patients in NT received the normal physical
therapy in the conventional medical wards, the duration and amount of which was determined by the internists. The patients were discharged from these departments to their homes or, if it was not possible, to
old age homes or chronic care departments of community hospitals, where some of them were able to obtain
physiotherapy. The guiding principle was, however,
that no patient's therapy was worsened as a result of
the study.
The patients in IT were also initially treated in medical wards of the local University Hospital. After this
initial period the majority of patients was admitted to
Vaajasalo Hospital. This hospital is a former epilepsy
hospital which is now a part of the regional neurological health care organization. Its one department was
redesigned into a rehabilitation unit with the purpose
especially to treat stroke patients. The rest of patients
in IT were treated in neurological wards of the University Hospital. The principle was that physiotherapy
should be given as long as functional recovery was
taking place or the patient could perform independently at home. The amount of therapy was measured as
the number of sessions of therapy given by physical,
occupational or speech therapist. Usually one physiotherapy session lasted half an hour. When a patient in
IT was in the medical ward of University Hospital,
she/he was treated by a physiotherapist twice a day.
Statistical Methods
The significance of the difference between the
means of two independent groups was calculated with
student's t-test. The analysis of covariance was applied
in the study, when the material could be corrected in
regard to the confounding factors.
Results
The Amount of Treatment
There was no statistically significant difference between the groups according to the length of stay in
hospital, six and twelve months after the stroke.
At the three-month follow-up, patients in IT had
significantly more rehabilitation days than NT (p <
0.05). However, at 6 and 12 months after the stroke
there was no difference (table 2). At the three-month
follow-up, there was a statistically significant difference between study groups in terms of the frequency of
treatment by a physical therapist (p < 0.01) and assis-
STROKE
930
TABLE 2 Mean Length of Rehabilitation (Days + SE) in the
Intensive and Normal Treatment Group 3, 6 and 12 Months after
the Stroke
Time
period
from the
stroke
3 months
6 months
12 months
Rehabilitation days
Intensive
treatment
Normal
treatment
45.7 + 2.7
(n = 50)
68.2 + 5.0
(n = 48)
85.4 + 7.7
(n = 47)
37.1+3.5
(n = 43)
63.0 + 6.9
(n = 41)
84.3 ±11.3
(n = 39)
Significance of
difference
p < 0.05
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TABLE 3 Mean Frequency (+ SE) of Treatment Given by Physical Therapist, Assistant Physical Therapist, Occupational Therapist and Speech Therapist in the Intensive and Normal Treatment
Group 3, 6 and 12 Months after the Stroke
Therapist
3 months
physical
assistant
physical
occupational
6 months
physical
assistant
physical
occupational
12 months
physical
assistant
physical
occupational
speech
Intensive
treatment
Normal
treatment
Significance of
difference
45.7±2.7
32.3±3.5
p < 0.01
22.3 ±3.4
1.1 ±0.4
(n = 50)
14.0±2.6
0.9±1.4
(n = 43)
p < 0.05
n.s.
66.2±7.3
50.6±6.7
n.s.
33.9 + 5.7
1.1 ±0.4
(n = 47)
28.7±6.1
1.2±0.5
(n = 39)
n.s.
n.s.
85.7±11.3
66.9±9.6
39.1±7.6
1.1 ±0.4
43.6±10.5
0.9±0.4
2.4± 1.5
(n = 35)
1.3±0.5
(n = 42)
Time
from the
stroke
One week
6 months*
Effect of Rehabilitation on Functional Recovery arid
Outcome of Patients
In the analysis of covariance there was a difference
of 28% (p < 0.01) between study groups for ADL
scores at 3 month follow-up (table 4) in favour of IT.
The difference persisted also at 6 and 12 months, but
was not statistically significant. In this analysis the
difference in the initial ADL score between the study
groups was taken into consideration, and a covariance
adjustment was made to allow for this difference. The
initial ADL score was lower in IT (p < 0.05), but after
three months the situation was reversed. The effect of
12 months*
1985
Intensive
treatment
10.5± 1.3
(n = 50)
21.0+1.3
(n = 41)
21.6±1.2
(n = 42)
21.1 + 1.3
(n = 42)
ADL score
Normal
treatment
13.6± 1.7
(n = 45)
16.3± 1.7
(n = 33)
18.6± 1.5
(n = 35)
18.4± 1.6
(n = 35)
Relative
difference
23t
291:
16
15
•Difference between means in relation to normal treatment group
mean, statistical significance by ANCOVA with covariance adjustment for age (p < 0.01) and one-week ADL score (p < 0.001) and
with sex as another factor (n.s.), indicated as tp < 0.05 and \p <
0.01.
age was statistically significant (p < 0.001), while that
of sex and interaction of sex and study groups was not
at any time point of follow-up.
There was significant difference between study
groups in gain of motor function at 3 and 6 months (p
< 0.01), and 12 months (p < 0.05) (table 5). As was
the case with ADL, the initial motor function score
was also significantly (p < 0.001) different in the two
groups. Age, sex and interaction of sex and study
group had no statistically significant effect.
Outcome of Patients
There were only five recurrences of stroke, three of
them in IT. There was no statistical difference between
the groups. Six months after the stroke the mortality
was slightly higher in NT, arid at the 12-month followup the patients of this group were more often in an
TABLE 5 Age, Sex and Initial ADL Score Adjusted Means (± SE)
of Motor Function Test Score at 3,6 and 12 Months after the Stroke
in the Intensive and Normal Treatment Group. Adjustment by Analysis of Covariance
Time
period
from the
stroke
One week
3 months*
6 months*
12 months*
n.s.
n.s.
n.s.
16, No 6, NOVEMBER-DECEMBER
TABLE 4 Age, Sex and Initial ADL Score Adjusted Means ( ± SE)
of ADL Score at 3, 6 and 12 Months after the Stroke in the Intensive and Normal Treatment Group. Adjustment by Analysis
of Covariance
3 months*
tant physical therapist (p < 0.05) in favor of IT (table
3). At later follow-up there were no statistically significant differences.
Frequency of therapy
VOL
Motor function test score
Normal
Relative
Intensive
difference
treatment
treatment
15.7+1.7
(n = 50)
26.4±2.5
(n = 38)
26.9±2.4
(n = 40)
26.0±2.9
(n = 40)
19.0 + 2.1
(n = 45)
20.2 ±2.2
(n = 32)
21.0±2.1
(n = 35)
21.1 ±2.3
(n = 35)
17t
31*
28$
23t
•Difference between means in relation to normal treatment group
mean, statistical significance by ANCOVA with covariance adjustment for age (n.s.) and one-week motor function test score (p <
0.001) and with sex as another factor (n.s.), indicated as tp < 0.05
and tp < 0.01.
INTENSITY OF STROKE REHABILITATION/Sivemiw et al
institution. However, these differences were not statistically significant.
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Discussion
On the basis of historical data, the groups were
comparable in terms of age, diagnostic distribution,
social class, working capacity, ADL, prevalence of
primary cardiovascular diseases and diabetes mellitus.
However, the ADL and motor function scores differed
at the time of one week follow-up between the two
groups so that IT had lower scores. This fact was
equalized in the analysis of covariance. Length of therapy was considered as the number of days including
skilled physiotherapy, while the frequency as the number of sessions of therapy was given.
Three months after the stroke patients in IT had
received statistically more physiotherapy and more
frequent treatment by a physical therapist and an assistant physical therapist. At the 6- and 12-month followups the differences were not statistically significant.
The amount of occupational therapy was quite low,
and there was no difference between the groups.
In the study of Smith et al6 patients in the intensive
care group received twice as much physio- and occupational therapy as those in conventional rehabilitation.
Garraway et al4 reported that patients in medical units
had significantly longer and more frequent treatment
than those in the stroke unit although these latter patients had received more occupational therapy.
One problem in controlled rehabilitation studies is
that many of the control patients begin the rehabilitation on their own initiative. Furthermore, the general
level of stroke care and the attitudes of staff may improve as a result of the study.
The amount of speech and occupational therapy was
quite low among patients, and there was no difference
in the amounts between the study groups. In addition
to physiotherapy, the result may have been influenced
by two confounding factors, namely the possible difference in general care of the IT and NT groups and the
difference in atmosphere and attendance of the staff in
the hospitals the patients were treated. These things
can rarely be avoided in any rehabilitation study, since
the therapy can never be "blind" and the patient groups
often are treated in separate wards.
Patients with the best improvement were discharged
home, so that active therapy was usually no longer
possible. Patients with slower recovery were more often institutionalized and thus continued to receive
physical therapy. The proportion of patients of both
groups in institution after six and twelve months was
approximately equal. Garraway et al4 and Brocklehurst
et al9 have stated that the quantity of therapy was greatest in the groups of patients who were most disabled.
These factors may also have affected the amount of
931
therapy given to IT and NT patients and may partly
explain the disappearance of statistical significance
after the three month follow-up.
Rehabilitation seems to improve the prognosis of
functional recovery of stroke patients. The motor function scores of the intensively treated patients were significantly higher than that of those who received only
routine treatment. The improvement was greatest during the first three months after stroke. The impact of
rehabilitation on activities of daily living appears
smaller than on motor function. The utilization of occupational therapy at the time of the study was relatively small because of the lack of qualified personnel. The
significance of occupational therapy to the ADL has
been clearly shown.4 In the present data an effect of
rehabilitation was detected only during the three first
months. There was a difference in length and frequency of physical therapy between groups at three months,
but not later on. It seems that the first three months are
of special importance in the rehabilitation of stroke
patients.
No effect on the outcome of patients was detected in
terms of death or institutionalization in this study, even
if percentially both these outcomes were slightly more
common among the patients who received normal
treatment. In two recent studies4-7 there was similarly a
trend towards better survival in the intensively treated
group of patients. The small sample size makes it rather difficult throughout the study to reach statistically
significant differences between the groups. Probably
some part of negative results or disappearance of differences is due to type II error.
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The significance of intensity of rehabilitation of stroke--a controlled trial.
J Sivenius, K Pyörälä, O P Heinonen, J T Salonen and P Riekkinen
Stroke. 1985;16:928-931
doi: 10.1161/01.STR.16.6.928
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