Effect of virtual reality on physical and mental health in patient with stroke
| ISRCTN | ISRCTN04144761 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04144761 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/10/2014
- Registration date
- 29/10/2014
- Last edited
- 29/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
161 Jeongneung-ro, Seongbuk-gu
Seoul
136-703
Korea, South
| yoonbc@korea.ac.kr |
Study information
| Study design | Randomized three arm controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, Please use contact details below to request a patient information sheet. |
| Scientific title | Effect of virtual reality on physical and mental health in patient with stroke: a randomized controlled trial |
| Study objectives | 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(s) | The Institutional Review Board of Korea University. Seoul, Korea, 19/06/2014, ref: KU-IRB-14-76-A-2 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2014 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Community-dwelling patient with stroke aged over 30 years 2. Onset of a unilateral stroke at least one month previously |
| Key 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 |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
136-703
Korea, South
Sponsor information
University/education
126-1
Anam-dong 5-ga
Sungbuk-gu
Seoul
136-705
Korea, South
| interlaw88@korea.ac.kr | |
"ROR" |
https://ror.org/047dqcg40 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
