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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02029651
First Posted: January 8, 2014
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Trade, Industry & Energy, Republic of Korea
National IT Industry Promotion Agency, Republic of Korea
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Joon-Ho Shin, 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 ]

Secondary Outcome Measures:
  • Fugl-meyer assessment_upper extremity [ Time Frame: 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 ]
  • Purdue pegboard [ Time Frame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention ]
  • Stroke impact scale [ Time Frame: Baseline, after 20th intervention ]
  • Modified Ashworth scale of affected upper extremity [ Time Frame: Baseline, after 20th intervention ]
  • Medical research council scale of muscle strength of affected upper extremity [ Time Frame: Baseline,after 20th intervention ]
  • Satisfaction about intervention [ Time Frame: after 20th intervention ]
    only for the participants of E-glove intervention


Estimated Enrollment: 59
Study Start Date: January 2014
Estimated Primary Completion Date: April 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029651


Locations
Korea, Republic of
National Rehabilitation Center
Seoul, Korea, Republic of, 142884
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 1, 2014
First Posted: January 8, 2014
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
Stroke
Hand
Rehabilitation
Game

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


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