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

Primary Purpose

Upper Extremity Dysfunction After the Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality program for upper extremity rehabilitation
standard occupational therapy
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Extremity Dysfunction After the Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality program

Control

Arm Description

mobile device for virtual reality program

standard occupuational therapy

Outcomes

Primary Outcome Measures

Fugl-Meyer upper extremity scale
for motor evaluation

Secondary Outcome Measures

brunnström stage
for motor evaluation
Modified Barthel Index
for ADL independence
Medical Research Council (MRC) Scale for Muscle Strength
for motor evaluation
Euroqol(EQ)-5D
EQ-5D
Virtual reality kinematic data
Automatically recorded
questionnaire
for user satisfaction

Full Information

First Posted
December 3, 2013
Last Updated
January 28, 2018
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02013999
Brief Title
The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients
Official Title
Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 24, 2014 (Actual)
Study Completion Date
November 24, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Dysfunction After the Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality program
Arm Type
Experimental
Arm Description
mobile device for virtual reality program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
standard occupuational therapy
Intervention Type
Other
Intervention Name(s)
Virtual reality program for upper extremity rehabilitation
Intervention Type
Other
Intervention Name(s)
standard occupational therapy
Primary Outcome Measure Information:
Title
Fugl-Meyer upper extremity scale
Description
for motor evaluation
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
Secondary Outcome Measure Information:
Title
brunnström stage
Description
for motor evaluation
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
Title
Modified Barthel Index
Description
for ADL independence
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
Title
Medical Research Council (MRC) Scale for Muscle Strength
Description
for motor evaluation
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
Title
Euroqol(EQ)-5D
Description
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
Title
Virtual reality kinematic data
Description
Automatically recorded
Time Frame
everytime when the patient uses program (automatically all recorded)
Title
questionnaire
Description
for user satisfaction
Time Frame
at the end of the treatment for 2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital, Seongnam, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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