Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients

Study Overview
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Brief Summary
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The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.

Official Title
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Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Smart glove system with functional electrical stimulation
* Device: Functional electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first-ever ischemic or hemorrhagic stroke wrist extensor of medical research council scale 1 3 No clinical evidence of limited passive range of motion of affected wrist Exclusion Criteria: age <18 years severe aphasia resulting in communication difficulties confounding intervention and outcome measures severe cognitive impairment resulting cooperation difficulties spasticity > modified Ashworth scale 1+

Ages Eligible for Study
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Minimum Age: 19 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: Smart glove system with functional electrical stimulation<br>game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity | Device: Smart glove system with functional electrical stimulation<br>* Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity<br>|
| Active Comparator: Functional electrical stimulation<br>functional electrical stimulation on upper extremity | Device: Functional electrical stimulation<br>* Functional electrical stimulation on distal upper extremity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test |  | 4 weeks from baseline | 
| Fugl-Meyer Assessment-hand & wrist |  | 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Box and Block Test | number of block transferred by hand from one box to other box. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Fugl-Meyer Assessment upper extremity | global assessment of upper extremity impairment | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke Impact Scale |  | baseline, 4 weeks after baseline | 
| Motor Activity Log |  | baseline, 4 weeks after baseline | 
| Medical research council scale of elbow flexion/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Medical research council scale of wrist flexion/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Range Of Motion of elbow flexion/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Range Of Motion of wrist flexion/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Brunnstrom stage | It represent the recovery status among stroke patients | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Jebsen-Taylor hand function test |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Modified Ashworth scale of elbow flexor/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Modified Ashworth scale of wrist flexion/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Modified Tardieu scale of elbow flexor/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Modified Tardieu scale of wrist flexion/extension |  | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Adverse events | Any adverse events | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, Hand, Game, Functional electrical stimulation, Virtual reality