Condition category
Circulatory System
Date applied
20/10/2014
Date assigned
29/10/2014
Last edited
29/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study is aimed at comparing the effects of virtual reality (VR) based rehabilitation, group-based rehabilitation, and no rehabilitation at all on upper extremity (arms, upper body) function, daily activities, and general quality of life. Through this study, we would be able to suggest better ways of improving physical and mental health in people who have suffered a stroke and are living in the community.

Who can participate?
People who have suffered a stroke and are at least 30 years old.

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 take part in a newly developed VR-based rehabilitation programme. Those in group 2 take part in a conventional group-based rehabilitation programme. Those in group 3 are in a control group and don’t receive any rehabilitation at all. Participants in both rehabilitation programmes attend 30 minute training sessions three times a week for eight weeks.

What are the possible benefits and risks of participating?
The results of this study will be used to assess the success of VR-based and group-based rehabilitation which, in turn, will help in developing successful rehabilitation treatments for stroke patients in the community.

Where is the study run from?
The Applied NeuroDynamics Laboratory of Korea University (South Korea).

When is study starting and how long is it expected to run for?
August 2014 to December 2014.

Who is funding the study?
The Korea National Rehabilitation Institute (South Korea)

Who is the main contact?
Professor BumChul Yoon
yoonbc@korea.ac.kr

Trial website

Contact information

Type

Scientific

Primary contact

Prof BumChul Yoon

ORCID ID

Contact details

161 Jeongneung-ro
Seongbuk-gu
Seoul
136-703
Korea
South
yoonbc@korea.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of virtual reality on physical and mental health in patient with stroke: a randomized controlled trial

Acronym

Study hypothesis

This study is aimed at comparing the effects on upper extremity function, activities of daily living performance, and quality life between virtual reality-based rehabilitation, group-based rehabilitation, and non-rehabilitation.

Ethics approval

The Institutional Review Board of Korea University. Seoul, Korea, 19/06/2014, ref: KU-IRB-14-76-A-2

Study design

Randomized three arm controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, Please use contact details below to request a patient information sheet.

Condition

Stroke

Intervention

Newly developed motion free Virtual Reality (VR)-based rehabilitation and group-based rehabilitation will be conducted in a sitting position. Both rehabilitations will include 30-minute training program three times a week for eight weeks. Each of five-minute will be offered for a warm up and cool-down training. The therapeutic method, which were included in both rehabilitation is a proprioceptive neuromuscular facilitation (PNF) technique for the patient with unilateral stroke. Both interventions will be supervised by certified physical therapists for emergency.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Upper extremity function:
1. Fugl-Meyer Assessment (FMA), measured pre- and post-intervention
2. Manual Function Test (MFT), measured pre- and post-intervention
3. Box & Block Test (BBT), measured pre- and post-intervention
Activities of daily living performance:
1. Modified Bathel Index (MBI), measured pre- and post-intervention
Health-realted quality of life:
1. Short Form Health Survey (SF-12), measured pre- and post-intervention

Secondary outcome measures

1. Satisfaction (5 point Likert scale), measured post intervention
2. Intention to adherence (5 point Likert scale), measured post intervention
3. Expectation for therapeutic effect (5 point Likert scale), measured post intervention
4. Attendance rate, measured during intervention
5. Enjoyment, difficulty(0~10), measured post intervention

Overall trial start date

01/08/2014

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Community-dwelling patient with stroke aged over 30 years
2. Onset of a unilateral stroke at least one month previously

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Severe cognitive impairments unable to follow instructions
2. Listening or visual impairments
3. Dementia, headaches, or dizziness
4. Other neurologic, neuromuscular, or orthopedic disease

Recruitment start date

01/08/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Korea, South

Trial participating centre

161 Jeongneung-ro, Seongbuk-gu
Seoul
136-703
Korea, South

Sponsor information

Organisation

Korea University (South Korea)

Sponsor details

126-1
Anam-dong 5-ga
Sungbuk-gu
Seoul
136-705
Korea
South
interlaw88@korea.ac.kr

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Korean National Rehabilitation Institute (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes