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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
E-glove system
Conventional occupational therapy
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hand, Rehabilitation, Game

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E-glove system

Conventional occupational therapy

Arm Description

E-glove rehabilitation system for upper extremity

conventional occupational therapy

Outcomes

Primary Outcome Measures

Fugl-meyer assessment_upper extremity

Secondary Outcome Measures

Fugl-meyer assessment_upper extremity
Jebsen hand function test
Purdue pegboard
Stroke impact scale
Modified Ashworth scale of affected upper extremity
Medical research council scale of muscle strength of affected upper extremity
Satisfaction about intervention
only for the participants of E-glove intervention

Full Information

First Posted
January 1, 2014
Last Updated
April 13, 2015
Sponsor
National Rehabilitation Center, Seoul, Korea
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea, National IT Industry Promotion Agency, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02029651
Brief Title
Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke
Official Title
Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea, National IT Industry Promotion Agency, Republic of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Hand, Rehabilitation, Game

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-glove system
Arm Type
Experimental
Arm Description
E-glove rehabilitation system for upper extremity
Arm Title
Conventional occupational therapy
Arm Type
Active Comparator
Arm Description
conventional occupational therapy
Intervention Type
Device
Intervention Name(s)
E-glove system
Intervention Description
Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke
Intervention Type
Procedure
Intervention Name(s)
Conventional occupational therapy
Intervention Description
conventional occupational therapy
Primary Outcome Measure Information:
Title
Fugl-meyer assessment_upper extremity
Time Frame
Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention
Secondary Outcome Measure Information:
Title
Fugl-meyer assessment_upper extremity
Time Frame
Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Title
Jebsen hand function test
Time Frame
Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Title
Purdue pegboard
Time Frame
Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
Title
Stroke impact scale
Time Frame
Baseline, after 20th intervention
Title
Modified Ashworth scale of affected upper extremity
Time Frame
Baseline, after 20th intervention
Title
Medical research council scale of muscle strength of affected upper extremity
Time Frame
Baseline,after 20th intervention
Title
Satisfaction about intervention
Description
only for the participants of E-glove intervention
Time Frame
after 20th intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26911438
Citation
Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.
Results Reference
derived

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

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