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

This study is currently recruiting participants.
Verified January 2014 by National Rehabilitation Center, Seoul, Korea
Sponsor:
Collaborators:
Republic of Korea, Ministry of Trade, Industry & Energy
Republic of Korea, National IT Industry Promotion Agency
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier:
NCT02029651
First received: January 1, 2014
Last updated: January 18, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Stroke
Device: E-glove system
Procedure: Conventional occupational therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by National Rehabilitation Center, Seoul, Korea:

Primary Outcome Measures:
  • Fugl-meyer assessment_upper extremity [ Time Frame: Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Jebsen hand function test [ Time Frame: Change from baseline in Jebsen hand function test at 4 weeks after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 59
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02029651

Contacts
Contact: Joon-Ho Shin, MS 82-10-3168-7043 asfreelyas@gmail.com

Locations
Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS         
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Republic of Korea, Ministry of Trade, Industry & Energy
Republic of Korea, National IT Industry Promotion Agency
  More Information

No publications provided

Responsible Party: Joon-Ho Shin, Manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT02029651     History of Changes
Other Study ID Numbers: NRC-2013-04-035
Study First Received: January 1, 2014
Last Updated: January 18, 2014
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs
United States: Federal Government

Keywords provided by National Rehabilitation Center, Seoul, Korea:
Stroke
Hand
Rehabilitation
Game

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014