Virtual reality augmented exercise in multiple sclerosis patients
| ISRCTN | ISRCTN13924231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13924231 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/01/2012
- Registration date
- 01/03/2012
- Last edited
- 15/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
This study will investigate if using commercially available active gaming technology, or in other words, virtual reality (VR) augmented exercise, can help people affected by multiple sclerosis (MS). Many people with MS have problems with physical function and activity due to balance and muscle problems, as well as pain. This can be a primary factor in the restriction of their activities and therefore has a negative influence on their quality of life. There has been very little research published into the effects of using VR augmented exercise as a rehabilitation tool, and to the knowledge of the researcher there are no published studies investigating the use of this technology for people with MS.
Who can participate?
Men and women aged 18-65 years with a clinical diagnosis of MS.
What does the study involve?
Participants will be randomly allocated to one of three groups:
1. Four weeks of twice-weekly 40-minute sessions of supervised one-to-one visual reality (VR) augmented exercise using the Nintendo Wii™ and Wii Fit™ system.
2. Four weeks of twice-weekly 40-minute sessions of supervised one-to-one 'traditional' physiotherapy prescribed gym-based exercise.
3. Four weeks of usual care.
What are the possible benefits and risks of participating?
Participants may experience improvements in terms of pain and function.
Where is the study run from?
Teesside University (UK).
When is the study starting and how long is it expected to run for?
The study ran from August 2011 to April 2012.
Who is funding the study?
Teesside University (UK).
Who is the main contact?
Mr Jonathan Robinson
J.Robinson@tees.ac.uk
Contact information
Scientific
Teesside University
Phoenix Building
Middlesbrough
Cleveland
TS1 3BA
United Kingdom
| Phone | +44 (0)1642 738 313 |
|---|---|
| J.Robinson@tees.ac.uk |
Study information
| Study design | Exploratory randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An investigation of the use of virtual reality based augmented exercise for people with multiple sclerosis |
| Study hypothesis | The aims of the study are to investigate the effect of virtual augmented exercise on 1. The management of pain and function in multiple sclerosis (MS) as recorded through the MS walking scale, pain questionnaire and the World Health Organization Disability assessment Schedule II 2. Investigate the mechanisms underlying any effects through centre of pressure measures and physiological measures of electromyography (EMG) 3. Explore the usability and acceptance of the technology through questionnaires of usability and acceptance |
| Ethics approval(s) | 1. National Research Ethics Service Committee North East - Newcastle & North Tyneside 1, 21/06/2011, ref:11/NE/0151 2. Teesside University School of Health and Social Care Research Governance and Ethics Committee, 13/04/2011, ref: 097/11 |
| Condition | Multiple sclerosis |
| Intervention | Participants will be randomly allocated to one of three groups: 1. Four weeks, twice weekly, 40 minute sessions of supervised one-to-one visual reality (VR) augmented exercise using the Nintendo Wii™ and Wii Fit™ system 2. Four weeks, twice weekly, 40 minute sessions of supervised one-to-one 'traditional' physiotherapy prescribed gym based exercise 3. Four weeks of usual care (Control) |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Standing balance during quiet unipedal (standing on one foot) and bipedal (standing on two feet) stance recorded by Kistler™ force plate 2. Dynamic balance during sit-to-stand and ground reaction force 3. Temporal distance parameters of gait stride length, cadence, velocity, single and double limb support time 4. Measures of technology acceptance and exercise experience questionnaires |
| Secondary outcome measures | 1. Muscle activity: relationships between electromyography (EMG) and measures of static and dynamic postural stability 2. Self reported walking ability: differences in MSWS12 3. Self reported function: differences in WHODAS II, and pain questionnaires 4. Self reported exertion: Rating of Perceived Exertion |
| Overall study start date | 01/08/2011 |
| Overall study end date | 01/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 66 |
| Participant inclusion criteria | 1. Men and women 2. Aged 18-65 years 3. A clinical diagnosis of MS 4. Expanded Disability Status Scale (EDSS) score of one to six (Kurtzke, 1983) 5. Able to read and comprehend written and spoken English (regrettably validated translations of the outcome measure questionnaires are not available) |
| Participant exclusion criteria | 1. Currently in acute exacerbation and/or has relapsed within the last three months 2. Diagnoses of any other condition affecting the central nervous system 3. Any musculoskeletal injury or condition for which a health professional has advised the person to refrain from undertaking moderate physical activity 4. Any doubt of ability to give informed consent 5. Currently receiving physical therapy aimed at improvements in fitness and balance 6. Any allergy to conductance gel and/or hypoallergenic tape used during electromyography |
| Recruitment start date | 01/08/2011 |
| Recruitment end date | 01/04/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TS1 3BA
United Kingdom
Sponsor information
University/education
School of Health and Social Care
Middlesbrough
Cleveland
TS1 3BA
England
United Kingdom
| J.robinson@tees.ac.uk | |
| Website | http://www.tees.ac.uk |
"ROR" |
https://ror.org/03z28gk75 |
Funders
Funder type
University/education
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/04/2015 | Yes | No |
