Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

Study Overview
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Brief Summary
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Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough. Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign participants to standard treatment plus virtual reality group (N=30) and standard treatment only group (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month).Investigators will also record the pleasure scale and adverse event after every training session. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.

Detailed Description
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Many stroke survivors suffered postural and balance problems. Decreased mobility limits their daily life activities. Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. The mechanism is multi-sensory feedback and repeated practices that could facilitate motor learning and brain neuroplasticity. Compared to conventional rehabilitation, VR rehabilitation could increase subjects' motivation and pleasure. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough. The study will use Kinect for Xbox games for balance intervention. Kinect for Xbox doesn't need additional controller held by subjects and can detect the movement in real time to give subjects visual and auditory feedback immediately. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign them to standard treatment plus virtual reality group (N=30) and standard treatment only group (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month). The outcome measures include Force plate, Functional reach test, Berg Balance Scale, Time up and go for balance evaluations, Modified barthel index for ADL ability, Activities-specific Balance Confidence scale for balance confidence, and Stroke Impact Scale for quality of life. Investigators will also record the pleasure scale and adverse event after every training session. Collected data will be analyzed with repeated measures 2-way analysis of variance (ANOVA), Turkey test post hoc and independent T sample test. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.

Official Title
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Evaluation of the Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games for Patients With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Virtual reality
* Behavioral: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic stroke person (onset>6m) Could understand game command Could stand unsupported or stand with advice at least 15 minute Brunnstrom stage of LE ≥Ⅲ Exclusion Criteria: Age >75 years old or <20 years old Severe visual or auditory impairment Modified Ashworth Scale of LE ≥ 3 The Montreal Cognitive Assessment<16 Other medication(neural, cardio-pulmonary, musculoskeletal) that influence motor command during the game

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Virtual reality group<br>45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench. | Behavioral: Virtual reality<br>* 12 training sessions (90 minutes a time, 2 times a week) IG:45 minute of Kinect for Xbox games and 45 minute of standard treatment.<br>Behavioral: Standard treatment<br>* CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)<br>|
| Active Comparator: Standard treatment only group<br>90 min standard treatment. Depended on patient's ability, principle used by motor learning, sensory process, motor control, task oriented training, symmetry w't bearing. | Behavioral: Standard treatment<br>* CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | balance function | Change from Baseline at 6 weeks and 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified barthel index | Activity of daily live ability | Change from Baseline at 6 weeks and 3 month follow up | 
| Activities-specific Balance Confidence scale | balance confidence | Change from Baseline at 6 weeks and 3 month follow up | 
| Stroke Impact Scale | quality of life | Change from Baseline at 6 weeks and 3 month follow up | 
| Modified Physical Activity Enjoyment Scale | pleasure scale | Every training session during 6 weeks (total 12 sessions (2 times weekly)) | 
| Adverse event times |  | Every training session during 6 weeks (total 12 sessions (2 times weekly)) | 
| Force plate | balance function for Weight bearing symmetry and dynamic standing balance | Change from Baseline at 6 weeks and 3 month follow up | 
| Functional reach test | balance function | Change from Baseline at 6 weeks and 3 month follow up | 
| Timed up and go-cognition | balance function | Change from Baseline at 6 weeks and 3 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Virtual reality