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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02013999
Collaborator
(none)
33
1
2
13.8
2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality program for upper extremity rehabilitation
  • Other: standard occupational therapy
N/A

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
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 24, 2014
Actual Study Completion Date :
Nov 24, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer upper extremity scale [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

  1. 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]

    for motor evaluation

  2. 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]

    for ADL independence

  3. 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]

    for motor evaluation

  4. 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]

    EQ-5D

  5. Virtual reality kinematic data [everytime when the patient uses program (automatically all recorded)]

    Automatically recorded

  6. questionnaire [at the end of the treatment for 2 weeks]

    for user satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT02013999
Other Study ID Numbers:
  • B-1306/208-005
First Posted:
Dec 17, 2013
Last Update Posted:
Jan 30, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2018