Trial record 8 of 78 for:    Open Studies | "Occupational Therapy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 23, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Joon-Ho Shin National Rehabilitation Center
  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: August 23, 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 August 28, 2014