The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT02013999
First received: December 3, 2013
Last updated: July 13, 2014
Last verified: July 2014
  Purpose

Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.


Condition Intervention
Upper Extremity Dysfunction After the Stroke
Other: Virtual reality program for upper extremity rehabilitation
Other: standard 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Fugl-Meyer upper extremity scale [ Time Frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • brunnström stage [ Time Frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks ] [ Designated as safety issue: No ]
  • Modified Barthel Index [ Time Frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks ] [ Designated as safety issue: No ]
  • Medical Research Council (MRC) Scale for Muscle Strength [ Time Frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks ] [ Designated as safety issue: No ]
  • Euroqol(EQ)-5D [ Time Frame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks ] [ Designated as safety issue: No ]
    EQ-5D

  • Virtual reality kinematic data [ Time Frame: everytime when the patient uses program (automatically all recorded) ] [ Designated as safety issue: No ]
    Automatically recorded

  • questionnaire [ Time Frame: at the end of the treatment for 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Virtual reality program
mobile device for virtual reality program
Other: Virtual reality program for upper extremity rehabilitation
Active Comparator: Control
standard occupuational therapy
Other: standard occupational therapy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ischemic or hemorrhagic stroke confirmed by brain imaging study
  • upper extremity dysfunction
  • possible to use a simple device

Exclusion Criteria:

  • delirium, confusion or other evidence related to the consciousness
  • uncontrolled medical or surgical disease
  • unable to command to the order due to severe cognitive impairment
  • visual impairment
  • unable to sit
  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: NCT02013999

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
SungNam, KyungKi, Korea, Republic of, 463-707
Contact: Nam-Jong Paik, Professor    82-31-787-7731 ext 7731    njpaik@snu.ac.kr   
Principal Investigator: Nam-Jong Paik, Professor         
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02013999     History of Changes
Other Study ID Numbers: B-1306/208-005
Study First Received: December 3, 2013
Last Updated: July 13, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Musculoskeletal Diseases
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 26, 2014