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Clinical Trials/NCT02013999
NCT02013999
Completed
N/A

Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke

Seoul National University Bundang Hospital1 site in 1 country33 target enrollmentOctober 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Upper Extremity Dysfunction After the Stroke
Sponsor
Seoul National University Bundang Hospital
Enrollment
33
Locations
1
Primary Endpoint
Fugl-Meyer upper extremity scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
November 24, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nam-Jong Paik

Professor

Seoul National University Bundang Hospital

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • brunnström stage(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)
  • Modified Barthel Index(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)
  • questionnaire(at the end of the treatment for 2 weeks)
  • Euroqol(EQ)-5D(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)
  • Virtual reality kinematic data(everytime when the patient uses program (automatically all recorded))
  • Medical Research Council (MRC) Scale for Muscle Strength(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)

Study Sites (1)

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