Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer upper extremity scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Virtual reality program
mobile device for virtual reality program
Intervention: Virtual reality program for upper extremity rehabilitation (Other)
Control
standard occupuational therapy
Intervention: standard occupational therapy (Other)
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)
Investigators
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital