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

National Rehabilitation Center, Seoul, Korea1 site in 1 country54 target enrollmentFebruary 2015

ConditionsStroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stroke
Sponsor: National Rehabilitation Center, Seoul, Korea
Enrollment: 54
Locations: 1
Primary Endpoint: Fugl-Meyer Assessment-hand & wrist
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Rehabilitation Center, Seoul, Korea

Responsible Party

Principal Investigator

Joon-Ho Shin

Manager

National Rehabilitation Center, Seoul, Korea

Eligibility Criteria

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+

Outcomes

Primary Outcomes

Fugl-Meyer Assessment-hand & wrist

Time Frame: 4 weeks from baseline

Wolf Motor Function Test

Time Frame: 4 weeks from baseline

Secondary Outcomes

Box and Block Test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Stroke Impact Scale(baseline, 4 weeks after baseline)
Range Of Motion of wrist flexion/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)
Adverse events(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Wolf Motor Function Test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Brunnstrom stage(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Fugl-Meyer Assessment upper extremity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 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)
Modified Ashworth scale of elbow flexor/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)
Jebsen-Taylor hand function test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)