Contact information
Type
Scientific
Contact name
Dr Sarah Thomas
ORCID ID
Contact details
Bournemouth University
Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom
-
saraht@bournemouth.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
13130
Study information
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
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
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
UK Sample Size: 30
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
Sponsor information
Organisation
Poole Hospital NHS Foundation Trust (UK)
Sponsor details
Dorset Research and Development Support Unit
Cornelia House
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Society (UK)
Alternative name(s)
Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |