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

April 13, 2015 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

59

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: E-glove system
E-glove rehabilitation system for upper extremity
Device: E-glove system
Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke
Active Comparator: Conventional occupational therapy
conventional occupational therapy
Procedure: Conventional occupational therapy
conventional occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-meyer assessment_upper extremity
Time Frame: Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention
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
Time Frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Jebsen hand function test
Time Frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Purdue pegboard
Time Frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Stroke impact scale
Time Frame: Baseline, after 20th intervention
Baseline, after 20th intervention
Modified Ashworth scale of affected upper extremity
Time Frame: Baseline, after 20th intervention
Baseline, after 20th intervention
Medical research council scale of muscle strength of affected upper extremity
Time Frame: Baseline,after 20th intervention
Baseline,after 20th intervention
Satisfaction about intervention
Time Frame: after 20th intervention
only for the participants of E-glove intervention
after 20th intervention

Collaborators and Investigators

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

Sponsor

National Rehabilitation Center, Seoul, Korea

Collaborators

Ministry of Trade, Industry & Energy, Republic of Korea
National IT Industry Promotion Agency, Republic of Korea

Investigators

  • Principal Investigator: Joon-Ho Shin, National Rehabilitation Center

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

January 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

January 1, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2013-04-035

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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