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

October 23, 2016 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 142884
        • Recruiting
        • National Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smart glove system with functional electrical stimulation
game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity
Device: Smart glove system with functional electrical stimulation
Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity
Active Comparator: Functional electrical stimulation
functional electrical stimulation on upper extremity
Device: Functional electrical stimulation
Functional electrical stimulation on distal upper extremity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wolf Motor Function Test
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Box and Block Test
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
global assessment of upper extremity impairment
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke Impact Scale
Time Frame: baseline, 4 weeks after baseline
baseline, 4 weeks after baseline
Motor Activity Log
Time Frame: baseline, 4 weeks after baseline
baseline, 4 weeks after baseline
Medical research council scale of elbow flexion/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Medical research council scale of wrist flexion/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range Of Motion of elbow flexion/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range Of Motion of wrist flexion/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Brunnstrom stage
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale of elbow flexor/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale of wrist flexion/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Tardieu scale of elbow flexor/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Tardieu scale of wrist flexion/extension
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Adverse events
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Any adverse events
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Rehabilitation Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2015-01-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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