The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients

Study Overview
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Brief Summary
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Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.

Detailed Description
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This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity [FMA-UE], Brunnstr¨om stage [B-stage] for the arm and the hand, manual muscle testing [MMT], modified Barthel index [MBI], EuroQol-5 Dimension [EQ-5D], and Beck Depression Inventory [BDI]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.

Official Title
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Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke

Conditions
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Upper Extremity Dysfunction After the Stroke

Intervention / Treatment
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* Other: Virtual reality program for upper extremity rehabilitation
* Other: standard occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic or hemorrhagic stroke confirmed by brain imaging study upper extremity dysfunction possible to use a simple device Exclusion Criteria: delirium, confusion or other evidence related to the consciousness uncontrolled medical or surgical disease unable to command to the order due to severe cognitive impairment visual impairment unable to sit
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality program<br>mobile device for virtual reality program | Other: Virtual reality program for upper extremity rehabilitation<br> <br> |
| Active Comparator: Control<br>standard occupuational therapy | Other: standard occupational therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer upper extremity scale | for motor evaluation | baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brunnström stage | for motor evaluation | baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks | 
| Modified Barthel Index | for ADL independence | baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks | 
| Medical Research Council (MRC) Scale for Muscle Strength | for motor evaluation | baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks | 
| Euroqol(EQ)-5D | EQ-5D | baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks | 
| Virtual reality kinematic data | Automatically recorded | everytime when the patient uses program (automatically all recorded) | 
| questionnaire | for user satisfaction | at the end of the treatment for 2 weeks |