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

January 28, 2018 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
Time Frame: everytime when the patient uses program (automatically all recorded)
Automatically recorded
everytime when the patient uses program (automatically all recorded)
questionnaire
Time Frame: at the end of the treatment for 2 weeks
for user satisfaction
at the end of the treatment for 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Nam-Jong Paik, Ph.D, Seoul National University Bundang Hospital, Seongnam, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 24, 2014

Study Completion (Actual)

November 24, 2014

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 28, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1306/208-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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