Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii™) to increase activity levels, vitality and well-being in people with MS
| ISRCTN | ISRCTN49286846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49286846 |
| Secondary identifying numbers | 13130 |
- Submission date
- 17/10/2012
- Registration date
- 18/10/2012
- Last edited
- 04/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Sarah Thomas
Scientific
Scientific
Bournemouth University
Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom
| saraht@bournemouth.ac.uk |
Study information
| Study design | Randomised interventional 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 the contact details to request a patient information sheet |
| Scientific title | Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii™) to increase activity levels, vitality and well-being in people with MS |
| Study acronym | Mii-vitaliSe |
| Study hypothesis | People with MS (pwMS) often find it difficult to exercise for a variety of different reasons (physical, social, psychological, environmental). Physical activity is important in maintaining health and in pwMS can help combat fatigue. The Nintendo Wii™ is an increasingly popular gaming system that offers possibilities for increasing physical activity at home in a fun, engaging way; perhaps leading to benefits in well-being and quality of life. Using the Wii™ in conjunction with individual support from a physiotherapist will help to ensure that pwMS use it in a safe and effective long-term way. The main aim of this project is to conduct a small pilot randomised controlled trial comparing: 1. pwMS using the Wii™ with physiotherapist support 2. pwMS not using the Wii™ We will follow up participants for up to a year and assess their use of the Wii™, their physical functioning, quality of life and general well-being. This pilot study will be a vital step in reducing uncertainties in designing and preparing for a much larger definitive study. For example, we will develop specific guidance for pwMS on using the Wii™ and test out procedures for a full-scale study. |
| Ethics approval(s) | 1. NRES South Central Southampton B Research Ethics Committee, 28/08/2012, IRAS Ref: 1369 2. NRES South Central Southampton B Research Ethics Committee, substantial amendment approval, 06/12/2012 |
| Condition | Nervous system disorders |
| Intervention | Mii-vitaliSe Week 1: Orientation to the Wii™ (hospital). Week 2: Training and individualised assessment (hospital). Week 3: Physiotherapist home visit; Wii™ equipment installed Independent home use with 2 home reviews visits and regular telephone monitoring. Participants receiving Mii-vitaliSe will continue to have access to services available as part of their usual local care. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Demographic/descriptor variables measured at baseline and 6 months |
| Secondary outcome measures | 1. 2 minute timed walk measured at baseline and 6 months 2. ActivPAL accelerometer measured at baseline and 6 months 3. Adherence measured throughout study duration 4. Adverse events measured throughout study duration 5. Euroqual 5 Dimensions-5 Levels measured at baseline and 6 months 6. Fatigue Symptom Inventory measured at baseline and 6 months 7. Gait-stride time rhythmicity measured at baseline and 6 months 8. Godin Leisure Time Questionnaire measured at baseline and 6 months 9. Hospital Anxiety and Depression Scale measured at baseline and 6 months 10. Multiple Sclerosis Impact Scale measured at baseline and 6 months 11. Multiple Sclerosis Self-Efficacy Scale measured at baseline and 6 months 12. Nine hole peg test measured at baseline and 6 months 13. Semi structured interviews measured at 6 months (12 months immediate group only) 14. Static Posturography measured at baseline and 6 months 15. Steady Stance test measured at baseline and 6 months 16. Step test measured at baseline and 6 months 17. The Medical Outcomes Short-Form Survey version 2 measured at baseline and 6 months 18. The Spinal Cord Injury Exercise Self-Efficacy Scale measured at baseline and 6 months 19. Timed Up and Go measured at baseline and 6 months |
| Overall study start date | 01/11/2012 |
| Overall study end date | 01/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 30 |
| Participant inclusion criteria | 1. Clinically definite diagnosis of MS 2. Aged 18 or above 3. 'Inactive' (typically physically active for 30 mins or more on fewer than 5 days/week 4. Living within Poole/Bournemouth conurbations 5. Fulfil risk assessment criteria - this will be undertaken by a Senior Physiotherapist in the home setting 6. Participants who can maintain independent static standing balance with eyes open for 1 minute 7. The physiotherapist clinically judges that the particpant can demonstrate adequate balance reactions while on the Wii™ balance board and are able to step off safely backwards and sidewards 8. The participants' home environment is suitable (with minor modifications, if appropriate and possible) for using the Wii™ equipment safely for exercise 9. Male or female particpants |
| Participant exclusion criteria | 1. If only have mild symptoms (equivalent to an Adapted Patient Determined Disease Steps Scale of 1 (EDDS of 1) Require at least intermittent assistance (cane, crutch or frame) to walk 100 metres with or without resting (Equivalent to an APDDS and EDSS score of 6 or more). 2. Relapse within past 3 months requiring corticosteroids 3. Already participating in exercise/rehabilitation research 4. Medical condition placing participant at risk this will be based on their neurologist's judgement 5. Owns a Wii™ and uses it regularly (weekly or more) 6. Unwilling or unable to comply with protocol 7. Not in possession of a suitable television |
| Recruitment start date | 01/11/2012 |
| Recruitment end date | 01/09/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bournemouth University
Bournemouth
BH1 3LT
United Kingdom
BH1 3LT
United Kingdom
Sponsor information
Poole Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Dorset Research and Development Support Unit
Cornelia House
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
| Website | http://www.poole.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03kdm3q80 |
Funders
Funder type
Charity
Multiple Sclerosis Society (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/05/2014 | Yes | No | |
| Results article | results | 27/09/2017 | Yes | No |
Editorial Notes
04/10/2018: Publication reference added.
06/03/2014: The overall trial end date was changed from 01/07/2013 to 01/09/2014.
