Effects of Virtual Reality Game on Upper Extremity Function for Stroke

Study Overview
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Brief Summary
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Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the systems require a continuous sightline or enough active range of motion which may increase risk of compensatory movement. Few of studies had investigated the rehabilitation effects on upper extremity with Pablo for patients with stroke.The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.

Detailed Description
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PURPOSE: The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke. METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to VR plus standard rehabilitation group(n=19), and standard rehabilitation group (n=19). After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS version 20.0, and alpha level was set at 0.05.

Official Title
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Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: virtual reality game traning
* Behavioral: standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First stroke with hemiplegia, Chronicity of >6 months Could understand instructions Brunnstrom stage of UE ≥IV. Exclusion Criteria: Patients who were aged <20 years and >75 years Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly Montreal Cognitive Assessment <16 Modified Ashworth Scale score of >2 Patients with other medical symptoms that can affect movement were excluded.

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>Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks. | Behavioral: virtual reality game traning<br>* The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.<br>Behavioral: standard treatment<br>* The program included bilateral hand, grasp/release, and pinch activities.<br>|
| Active Comparator: standard treatment group<br>Standard treatment 60 minutes, twice a week for 9 weeks. | Behavioral: standard treatment<br>* The program included bilateral hand, grasp/release, and pinch activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment-upper extremity | The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66. | Change from Baseline at 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and block test | The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s. | Change from Baseline at 9 weeks | 
| Dynanometer | The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position. | Change from Baseline at 9 weeks | 
| Active range of motion of shoulder and elbow | The active range of motion of shoulder and elbow were measured through pablo system. | Change from Baseline at 9 weeks | 
| Stroke Impact Scale | The Stroke Impact Scale (SIS) is a quality of life measure designed specifically for patients with stroke. The instrument is a self-report questionnaire assessing eight domains: strength, hand function, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and social participation. | Change from Baseline at 9 weeks | 
| Modified Physical Activity Enjoyment Scale | It is an scale that assesses enjoyment for physical activity by asking participants to rate how you feel at the moment about the physical activity you have been doing using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). | Every training session during 18 sessions, total sessions continued to 9 weeks | 
| Adverse effect times | To record the adverse effect times during the therapy. | Every training session during 18 sessions, total sessions continued to 9 weeks |