Archives of Physical Medicine and Rehabilitation journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2015;-:------- ORIGINAL ARTICLE Computer-Assisted Training as a Complement in Rehabilitation of Patients With Chronic Vestibular DizzinessdA Randomized Controlled Trial Michael Smaerup, PT, MA,a Erik Grönvall, MScEng, PhD,b Simon B. Larsen, MScEng, PhD,c Uffe Laessoe, PT, PhD,d Jens-Jacob Henriksen, MD,e Else Marie Damsgaard, MDf From the aDepartment of Geriatrics, Aarhus University Hospital, Aarhus C; bComputer Games and Interaction Design, IT University of Copenhagen, Copenhagen S; cAlexandra Institute Ltd, Aarhus N; dDepartment of Health Science and Technology, Aalborg University, Aalborg; e Ear, Nose, and Throat Department, Aarhus University Hospital, Aarhus C; and fDepartment of Geriatrics, Aarhus University Hospital, Aarhus C, Denmark. Abstract Objective: To compare a computer-assisted home exercise program with conservative home-training following printed instructions in the rehabilitation of elderly patients with vestibular dysfunction. Design: Single-blind, randomized, controlled trial. Setting: Geriatric department of a university hospital. Participants: Patients with chronic dizziness due to vestibular dysfunction (NZ63) were randomly assigned to either rehabilitation in the clinic followed by computer-assisted home exercises (intervention group: nZ32) or rehabilitation in the clinic followed by home exercises according to printed instructions (control group: nZ31). Interventions: Patients in the intervention group received assisted rehabilitation by a computer program. Main Outcome Measures: Measurements at baseline and at 8 and 16 weeks were compared. These included the One Leg Stand Test, Dynamic Gait Index, Chair Stand Test, Motion Sensitivity Test, Short Form-12, Dizziness Handicap Inventory, and visual analog scale. Results: Both groups improved significantly during 16 weeks of rehabilitation. However, neither t tests nor repeated-measures analysis of variance demonstrated any significant differences between the 2 groups. The overall compliance rate to computer program exercises during 16 weeks was 57%. Conclusions: A computer-assisted program to support the home training of elderly patients with vestibular dysfunction did not improve rehabilitation more than did printed instructions. Archives of Physical Medicine and Rehabilitation 2015;-:------ª 2015 by the American Congress of Rehabilitation Medicine Dizziness is considered to be the most common complaint of patients 75 years and older.1 Sloane and Baloh2,3 reported that 46% of 116 patients older than 70 years referred to a neurootology clinic for dizziness presented with vestibular disorders. Also, a study of 6785 persons included in the U.S. National Health and Nutrition Examination surveys showed a significant increase in the prevalence of vestibular dysfunction with age.4 Supported by the Danish Health Foundation, Ejnar and Aase Danielsen Foundation, the Association of Danish Physiotherapists, the Department of Clinical Medicine, Aarhus University, and the Helene Elsass Center. Clinical Trial Registration No.: NCT01344408. Disclosures: none. A 2012 Cochrane review demonstrated that about 30% of people 65 years or older experience a fall, with a higher incidence among older people living in institutions.5,6 Ninety-five percent of all hip fractures resulting in hospitalization, disability, or death are caused by falls.7 Vestibular dysfunction is recognized as an intrinsic factor leading to falls,8 and vestibular rehabilitation (VR) has been shown to reduce the risk.8-10 A Cochrane review concluded that evidence for the efficacy of VR in patients with vestibular dysfunction was moderate to strong.11 Another review looked at the effects of VR in middle-aged and older adults and found evidence for a positive effect of VR in elderly patients with vestibular disturbances.12 Numerous studies of patients with 0003-9993/14/$36 - see front matter ª 2015 by the American Congress of Rehabilitation Medicine http://dx.doi.org/10.1016/j.apmr.2014.10.005 2 M. Smaerup et al chronic vestibular dysfunction indicate that individualized treatment strategies are more useful than general protocols; hence, VR planning is a specialized task.13,14 Several authors report that a reduction in dizziness by VR can be achieved only by combining rehabilitation at a clinic with daily home exercises.12,15 However, compliance with home exercises can be poor among elderly patients.16,17 The development of video games over the last decade has led to programs designed to rehabilitate or train their players.17,18 A generally accepted view is that video games may improve rehabilitation, but their practicality and benefits require validation. So far, the games have been used in clinical settings, but not in home environments where an important proportion of VR must occur to be successful.18 The objective of the study was to compare a computer training program with conservative home-training according to printed instructions in the rehabilitation of elderly patients with vestibular dysfunction. Methods A possible support for home rehabilitation may be the computer training program “Move It To Improve It” (Mitii).a It has been used to home-train patients with cerebral palsy. Its exercises are both motivating and guiding.19 Mitii represents a “low-tech” solution that simply requires a webcam-enabled computer. For the present study, the program was adapted for patients with vestibular dysfunction. The project took place in the Department of Geriatrics, The Falls Prevention Clinic, Aarhus University Hospital, Aarhus C, and in the ENT Department, Aarhus University Hospital, Aarhus C. Design This randomized study of patients with VR compared home exercises supported by the Mitii computer program with a control group given printed instructions. An assessor blinded to the exercise procedures examined all participants at baseline and after 8 and 16 weeks of exercises. The study was approved by the Danish National Committee on Health Research Ethics (project ID M-20090189) and the Danish Data Protection Agency (project ID 1-16-02-84-09). All participants gave informed and signed consent. Participants All patients (65y) presented with stable peripheral, central, and/or mixed vestibular dysfunction. Some were recruited from the Fall Clinic, Geriatric Department, Aarhus University Hospital, Denmark, after referral by their general practitioners or from the Emergency Department at Aarhus University Hospital. Others replied to a newspaper advertisement asking for volunteers. A geriatrician evaluated the causes of the patients’ falls. Those with vestibular dysfunction who agreed to participate in the project were referred to the Ear, Nose and Throat Department at Aarhus University Hospital to verify the diagnosis of vestibular dysfunction. Diagnostic tests comprised vestibular evoked myogenic potentials; subjective visual video head List of abbreviations: Mitii Move It To Improve It VR vestibular rehabilitation impulses (vertical and horizontal); spontaneous nystagmus; the bithermal caloric vestibular ocular reflex test (including visual suppression); an oculomotor test including saccades, smooth pursuit, and optokinetic responses; the Roll test; the Dix Hallpike, Hennebert gaze-induced nystagmus; and the Romberg nystagmus test. Exclusion criteria comprised unstable peripheral vestibular dysfunction, that is, Menière disease, benign paroxysmal positional vertigo, and acute neuronitis vestibularis. Other exclusion criteria were poor vision (6/60), contraindications to exercise therapy, significant cardiac problems, use of medicines with potential vestibular adverse effects (benzodiazepines and sedatives), dementia (Mini-Mental State Examination scores of <27, or a history suggesting dementia), stroke in the previous 6 months, other cognitive dysfunctions, and hip fracture within the last 3 months. Sample size and randomization Findings of a previous rehabilitation exercise trial in patients with dizziness showed a mean improvement of 6.68.4 seconds on the One Leg Stand Test for the intervention group compared with 0.46.9 seconds for the control group.20 On the basis of these figures, we expected a mean improvement of approximately 6 seconds for the intervention group compared with the control group in the present study. Hence, with a 2-tailed significance of 5%, 80% power, and an expectation of 15% dropouts, the sample size was estimated at 29 patients per rehabilitation group. Randomization after screening and before baseline assessments was provided by a central computer program with permuted block sizes and stratification according to peripheral, central, or mixed vestibular dysfunction. Accordingly, the computer program randomized patients to various blocks of 3, 6, or 9 patients and assigned a total of 32 patients to the intervention group and 31 to the control group (fig 1). Intervention Patients in the intervention and control groups received identical rehabilitation training at the hospital twice a week for 16 weeks. For both groups, rehabilitation at hospital was combined with home exercises. The intervention group was provided with a specifically adapted computer-based Mitii program, whereas the control group was given a printed home-training program. Rehabilitation aimed at (1) endurance training, (2) vestibular ocular reflex and cervical ocular reflex training for gaze stability, (3) resetting the vestibular ocular reflex gain, (4) enhancing smoothpursuit eye movements, and (5) using somatosensory and vestibular inputs for postural control. The Mitii training program was set up in the participants’ homes using an Internet-connected computer and a web camera connected to a cloud-based interactive training system using the Adobe Flash technology.b The system was developed by a collaboration between the Helene Elsass Centre, the Headfitted Software Development Company, and the University of Copenhagen.21-24 Participants logged into the Mitii website and accessed their individualized training program. The specific content and progression of the program were based on monthly evaluations of each patient’s performance. The level of difficulty was adjusted by increasing the task challenges (speed, number of repetitions, placing of target and pick-up area on the screen, size of objects, time to react, etc). A sequence of individual tasks and games was www.archives-pmr.org Computer-assisted training in rehabilitation Fig 1 3 Participants at each stage of the trial. Abbreviation: BPPV, benign paroxysmal positional vertigo. *Diagnosed after inclusion. arranged for a daily exercise program of 20 to 30 minutes (table 1). All exercises required patients to stand. Before each exercise, a short video showed the patient what to do. The program comprised drag-and-drop and follow-the-leader exercises. For drag-and-drop exercises, patients wore a headband with a green marker at the front. The computer webcam registered the position of the green marker and transferred this information to the screen cursor control (fig 2) for the cursor to be controlled by head movements. A virtual object on the screen was manipulated by grabbing and dragging it to a different location, or onto another virtual object. The exercises instigated head movements and challenged the vestibulo-ocular reflex (see table 1). Other exercises challenged the patients’ postural balance. A follow-theleader exercise uploaded a video sequence of a therapist’s movements that the patient was expected to follow visually. These exercises challenged the patient’s vestibulo-ocular reflex. After completing each exercise, a message, for example, “well done,” appeared on the screen. No other feedback was given concerning the manner or quality of performance. The duration of performance was registered and displayed for the hospital project physiotherapist who contacted participants if the program was not used for 7 days. The project physiotherapist (M.S.) gave intervention group patients oral and written instructions concerning Mitii home exercises. During the study period, the patients were contacted once a month by the physiotherapist to adjust the duration, speed, and difficulty of the exercises according to their progress. The physiotherapist and the patients also evaluated the compliance with Mitii. Home-training instructions for the control group were provided by hospital physiotherapists. Home exercises for the control group also addressed vestibulo-ocular reflex and balance training, as described and illustrated in their leaflet. No exercise follow-up was provided for the control group. Both groups were told to perform their exercises for 20 to 30 minutes at least once daily. www.archives-pmr.org Outcome measures The One Leg Stand Test20,25 for postural control measured the time (maximum, 30s) taken by the patients to move their feet from the start position. Both right and left leg stands were tested, and the best leg value was used in the analysis. The Dynamic Gait Index26 assessed dynamic postural stability as functional gait according to 8 tasks with varying demands, for example, walking at different speeds, walking with head turns, ambulation over and around obstacles, making a quick turn while walking, and ascending and descending stairs. Each item was rated on a 4-level ordinal scale, with a maximum score of 24. The Dizziness Handicap Inventory27 measured the effect of dizziness on quality of life. The Short Form-12 questionnaire28 assessed the quality of life. Responses to this questionnaire were summarized by independent Physical and Mental Composite scores. The Motion Sensitivity Test29 assessed the dizziness prompted by a series of 16 quick changes of head or body positions. The visual analog scale20 rated vertigo and unsteadiness on a 0 to 100mm scale, ranging from “no symptoms” to “worst possible.” The Chair Stand Test29,30 measured balance and strength of the lower extremities by recording the number of times (within 30s) a patient could rise from a chair. Baseline characteristics were also recorded: age, sex, duration of dizziness, and type of vestibular dysfunction (central, mixed, or peripheral). The number of hospital training sessions during the study period was registered manually. The number and duration of the Mitii sessions were recorded by the server. Statistical analysis Data were analyzed on intention-to-treat and per-protocol bases using STATA statistical software (version 12).c Two participants in the intervention group declined to participate but were assessed at baseline and at 8 and 16 weeks and were included in the intention-to-treat analysis. Groups were compared at baseline 4 M. Smaerup et al Table 1 Tasks and domains trained in the Mitii program and description of the corresponding actions* Task Task Description Action Domains Trained Flight simulator Ability to balance against series of lateral displacements Balance and postural control Follow the leader Follow a sequence of movements Shift weight from side to side with knee in w20 flexion and stabilize eyes on moving object Side-to-side head movement of w60 at a speed of 90 /s, 1.5Hz Move game Rotate head or flex/extend neck while focusing on a target Side-to-side head movement of w60 at a speed of 90 /s, 1.5Hz Follow game Ability to balance and activate larger muscle groups in lower extremities Shift weight from side to side with knee in w20 flexion and stabilize eyes on moving object Don’t move game Rotate head when fairy turns into green color Side-to-side head movement of w60 at a speed of 90 /s, 1.5hz Get up/get down Ability to balance and activate larger muscle groups in lower extremities Shift weight from side to side w20 knee flexion and get up and down from 90 knee flexion to full extension Vestibular ocular reflex and cervical ocular reflex for gaze stability Vestibular ocular reflex and cervical ocular reflex for gaze stability Saccadic eye movements for gaze stability Lower limb strength Balance Vestibular ocular reflex and cervical ocular reflex for gaze stability Lower limb strength Balance and postural control * The physiotherapist at the hospital is allowed to change the speed and the complexity of each task. using independent t tests. Repeated analysis of variance tests were used to analyze examinations at baseline and at 8 and 16 weeks. No significant differences were found between the 2 groups. The groups were also compared by paired and independent t tests (with confidence intervals). Exercise compliance in the intervention group was calculated by dividing the actual number of training sessions by the recommended number, that is, 16 weeks of once daily exercise training, which is 112 recommended sessions per patient. The Wilcoxon signed-rank test was used to analyze the change in compliance from baseline to 16 weeks of rehabilitation. Results The intervention and control groups did not differ significantly (>.05) on any variable at baseline (table 2). The mean duration of dizziness was >6 years. Central vestibular dysfunction was the most common diagnosis. The mean number of hospital sessions was 23 for the Mitii group and 24 for the control group contra 32 sessions recommended for both groups. Within-group rehabilitation effects were significant and showed improvement for both groups with respect to the Dynamic Gait Index and the Chair Stand Test. Also, the intervention group improved significantly with the Dizziness Handicap Inventory and Motion Sensitivity tests, but not significantly more than did the control group (table 3). Repeated analysis of variance tests at baseline and at 8 and 16 weeks did not show significant differences between the 2 groups. Also, analysis per-protocol did not show any significant difference between the intervention and control groups. During 112 possible days of home training, patients in the intervention group used the Mitii system once daily on 57% of the days (median, 51 sessions; 25th percentileZ19 sessions; 75th percentileZ65 sessions). The total duration of training sessions was not associated with outcome when tested using the Spearman rank correlation test (fig 3). Compliance with training peaked between 1 and 2 months of training (fig 4). Thereafter, compliance decreased and flattened for the rest of the study period. Discussion Overall effect of training on vestibular dysfunction The Dynamic Gait Index and the Chair Stand tests showed significant improvements for both groups. Thus, our results confirm the conclusions of other studies, that VR has an effect on patients with vestibular dysfunction.11 Effect of home training with a computer compared with written instructions Fig 2 Participant using Mitii. The computer training group did not improve significantly more than did the written instructions group. No significant betweengroup differences were observed with regard to any of the studied parameters. The intervention with Mitii showed a compliance rate of 57%. Other studies using more traditional home-training programs with instructions by physiotherapists www.archives-pmr.org Computer-assisted training in rehabilitation Table 2 5 We contacted patients only once a month and pointed out the data generated by the Mitii system to show their number of training sessions and total exercise times. Lange et al32 claimed that given the current level of technology, home exercise programs should be able to generate feedback to patients on both progress and compliance. The importance of feedback from physiotherapists could explain why studies using programs such as Nintendo Wii were effective with clinic patients aged approximately 40 years.33 Such results may not be transferable to older patients who collaborate less than do younger patients.34 The study showed that computer-assisted training and printed instructions were equally effective, and it appears that there is an overall need for improvement in home training of vestibular lesions. An earlier study of older patients stressed the importance of encouragement by an instructor,35 and another study concluded that therapists’ explanations and individually targeted exercises bear importantly on outcome.31 The program should also present patients with immediate feedback to motivate them to continue with their exercises.36 An alternative solution, demanding fewer resources, would be more frequent contact with the therapist to discuss rehabilitation goals plus, perhaps, more frequent exercise sessions. Exercise games and online contact with a physiotherapist should also be advantageous. Evidence suggests that rehabilitation is made more enjoyable and motivating when patients focus on a game (eg, Mitii) rather than on their impairment. Patients with vestibular dysfunction may then be more likely to continue with their exercises despite the many repetitions necessary to modulate neural function.32 Unfortunately, the current version of Mitii may not be the solution to this problem. Participant characteristics* Characteristic Women Age (y) Duration of dizziness (mo) Rehabilitation sessions at the hospital Types of vestibular dysfunction Peripheral Mixed Central Baseline score for outcome measures Dynamic Gait Index (points) Dizziness Handicap Inventory (points) Motion Sensitivity Test (points) Visual analog scale (mm) Chair Stand Test (rep) One Leg Stand Test (s) Short Form-12 Physical Composite Score (points) Short Form-12 Mental Composite Score (points) Mitii Group (nZ30) Control Group (nZ30) 18 (58) 76.657.56 58.0351.31 23.458.73 20 (65) 78.686.56 71.3551.08 24.238.09 2 (6) 4 (13) 25 (81) 2 (6) 6 (20) 23 (74) 16.354.02 41.6117.96 14.873.65 42.2618.81 25.4817.42 25.7423.14 37.8122.15 11.742.98 10.0610.06 38.8612.63 36.6522.20 10.712.82 8.278.97 35.1311.65 51.669.27 52.2512.76 NOTE. Values represent mean SD or n (%). * Wilcoxon signed-rank test, Student t test, and c2 test were used. yielded compliance rates of 30% to 57%.31 All studies found that compliance was highest at the start and decreases thereafter.31 We found the highest compliance in the first study period, but no significant difference in compliance from months 1 to 4. Hence, computer-based exercises at home cannot be claimed to produce better compliance than traditional hometraining exercises. Table 3 Study limitations Patients were recruited via general practitioners, from the Emergency Department at Aarhus University Hospital, or by newspaper advertisements. Hence, they may have had different motives for participating in the study. Patients responding to the advertisement may have been more fit than those referred by general practitioners who may have been less compliant. We did not measure the control Mean changes in outcome measures at baseline and at 16-wk follow-up* Mitii Group y Outcome Measures One Leg Stand test (s) Dynamic Gait Index (points) Dizziness Handicap Inventory (points) Motion Sensitivity Test (points) Visual analog scale (mm) Chair Stand Test (rep) Short Form-12 Physical Functioning (points) Short Form-12 Mental Functioning (points) Mean Change (CI) 2.09 (0.15 to 4.32) 1.37 (0.18 to 2.55) Control Group P Mean Change (CI) .066 .025 Difference Between Groups P Difference in Mean Change (CI) P 2.63 (0.17 to 5.44) 1.53 (0.44 to 2.63) .065 .007 0.55 (4.06 to 2.96) 0.17 (1.74 to 1.41) .755 .833 9.93 (15.27 to 4.60) <.001 5.20 (10.70 to 0.30) .063 4.73 (12.23 to 2.77) .212 10.50 (16.70 to 4.30) .002 7.17 (15.76 to 1.43) .099 3.33 (13.71 to 7.04) .523 5.93 (14.55 to 2.69) 1.33 (0.31 to 2.36) 2.70 (0.88 to 6.28) .170 .013 .134 6.30 (14.21 to 1.61) 1.33 (0.48 to 2.19) 3.18 (0.63 to 7.00) .114 .004 .098 0.37 (11.08 to 11.82) 0.00 (1.31 to 1.31) 0.48 (5.60 to 4.64) .949 1.000 .851 3.33 (0.72 to 7.38) .103 1.09 (2.66 to 4.84) .557 2.24 (3.16 to 7.64) .410 * For all measures except for Motion Sensitivity Test, Dizziness Handicap Inventory, and Visual Analog Scale higher values indicate better functioning. y Analysis are based on data from nZ30 in the Mitii group and n=30 in the control group. www.archives-pmr.org 6 M. Smaerup et al Fig 3 The association between exercise time and outcome in the intervention group. For all measures except Motion Sensitivity Test, Dizziness Handicap Inventory, and visual analog scale, higher values indicate better functioning. group compliance with printed instructions. Because no significant difference was detected between the intervention and the control groups, in contrast to significant within-group improvements, for certain outcome measures, we cannot exclude that it may have been VR at the clinic that produced the observed effects. A limitation to the validity of this study was its lack of “blinding” to treatments (participants and the therapists administering rehabilitation could not be blinded). An attempt was made to blind assessors measuring outcomes, but the fact that the measurements took place during 1-hour sessions introduced the risk of revealing the patients’ treatment groups. A further limitation is the Mitii system itself because it could not evaluate the quality of performance or indicate how the exercises were performed. Also, the system was unable to identify who performed the recorded exercises. Conclusions A computer-assisted program to support home training of elderly patients with vestibular dysfunction did not improve their VR more than did printed instructions given to a control group. Suppliers a. Mitii Development A/S. b. Adobe Systems. c. Stata, version 12; StataCorp. Keywords Patient compliance; Rehabilitation; Therapy, computer-assisted; Vestibular diseases Corresponding author Michael Smaerup, PT, MA, Department of Geriatrics, Research Division G, Aarhus University Hospital, P.P. Oerums Gade 11, Bldg 7, Aarhus C, Denmark. E-mail address: [email protected]. Acknowledgments Fig 4 Compliance in the rehabilitation period in the intervention group. Abbreviation: CI, confidence interval. 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