Home-based -Virtual Reality Intervention for Stroke Rehabilitation

Study Overview
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Brief Summary
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On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge. Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.

Detailed Description
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This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention. Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.

Official Title
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Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)

Conditions
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Stroke

Intervention / Treatment
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* Other: self-training using video-games
* Other: traditional self-training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 to 36 months after stroke onset lived in the community with family or a caregiver mild to moderate weakness the affected upper extremity without significant cognitive deficit able to walk at least 10-meters (with or without assistance). Exclusion Criteria: Other neurological conditions Epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-training using video-games<br>Participants will receive a video-game console and will be asked to play video-games for one hour a day X 6 days a week for 5 weeks. | Other: self-training using video-games<br>* Individuals will receive a video-game console and will be taught how to play the games. They will be requested to play 60 minutes a day for 5 weeks.<br>|
| Active Comparator: traditional self-training<br>Participants will receive a manual and kit of a traditional self-training program and will be asked to perform the program one hour a day X 6 days a week for 5 weeks. | Other: traditional self-training<br>* Individuals will receive a manual and equipment and will be taught how to perform the exercises. They will be requested to perform the exercises 60 minutes a day for 5 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-training time | Self-training time for the 5-week program as documented on a daily log sheet by the participants in both self-training programs. The mean weekly training hours per week will also be calculated. | week 9 | 
| Change in Action Research Arm Test | change in functional ability of the weaker upper extremity | week 0, week 4, week 9, week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Box and Block Test | Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test | week 0, week 4, week 9, week 13 | 
| Change in The Functional Reach Test | Change in standing balance | week 4, week 9, week 13 | 
| Daily enjoyment from the self-training | For each daily session participants rated their perceived enjoyment (1-5 points). | week 9 | 
| Change in the Motor Activity Log (MAL) | Change in daily use of the weaker upper extremity by using the MAL. This self-report questionnaire generates two seperate scores ranging from 0 to 5, regarding the amount and quality of the weaker upper extremity | week 0, week 4, week 9, week 13 | 
| Daily exertion from the self-training | For each daily session participants rated their perceived exertion (6-20 on the Borg scale). A mean score will be calculated per week. | week 9 | 
| Satisfaction from the self-training program | Satisfaction from the 5-week program and their perceived benefit from the program for improving their weaker upper extremity and balance on a 5-point Likert scale from not at all to very much. | week 9 |