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 dont 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