Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy

Official Title
-----------------
Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: E-glove system
* Procedure: Conventional occupational therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiplegic stroke patients Medical research council scale >= 2 of finger or wrist flexor/extensor Medical research council scale >= 2 of elbow pronation/supination Exclusion Criteria: Bilateral weakness of upper extremities Uncontrolled medical or surgical illness Predisposing psychological or neurological disorders Severe aphasia unable to communicate Severe cognitive impairment not to cooperate Severe pain impeding upper extremity rehabilitation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-glove system<br>E-glove rehabilitation system for upper extremity | Device: E-glove system<br>* Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke<br>|
| Active Comparator: Conventional occupational therapy<br>conventional occupational therapy | Procedure: Conventional occupational therapy<br>* conventional occupational therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-meyer assessment_upper extremity |  | Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-meyer assessment_upper extremity |  | Baseline, after 10th intervention, after 20th intervention, 1 month after intervention | 
| Jebsen hand function test |  | Baseline, after 10th intervention, after 20th intervention, 1 month after intervention | 
| Purdue pegboard |  | Baseline, after 10th intervention, after 20th intervention, 1 month after intervention | 
| Stroke impact scale |  | Baseline, after 20th intervention | 
| Modified Ashworth scale of affected upper extremity |  | Baseline, after 20th intervention | 
| Medical research council scale of muscle strength of affected upper extremity |  | Baseline,after 20th intervention | 
| Satisfaction about intervention | only for the participants of E-glove intervention | after 20th intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Hand, Rehabilitation, Game