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

This study has been completed.
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: June 26, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Nam-Jong Paik, 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 ]
    for motor evaluation


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 ]
    for motor evaluation

  • 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 ]
    for ADL independence

  • 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 ]
    for motor evaluation

  • 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 ]
    EQ-5D

  • Virtual reality kinematic data [ Time Frame: everytime when the patient uses program (automatically all recorded) ]
    Automatically recorded

  • questionnaire [ Time Frame: at the end of the treatment for 2 weeks ]
    for user satisfaction


Enrollment: 33
Study Start Date: October 2013
Study Completion Date: November 24, 2014
Primary Completion Date: November 24, 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

Detailed Description:
This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl−Meyer Assessment of the upper extremity [FMA-UE], Brunnstr¨om stage [B-stage] for the arm and the hand, manual muscle testing [MMT], modified Barthel index [MBI], EuroQol-5 Dimension [EQ-5D], and Beck Depression Inventory [BDI]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
SungNam, KyungKi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Nam-Jong Paik, Ph.D Seoul National University Bundang Hospital, Seongnam, South Korea
  More Information

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: June 26, 2017

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

ClinicalTrials.gov processed this record on July 24, 2017