Condition category
Nervous System Diseases
Date applied
17/10/2012
Date assigned
18/10/2012
Last edited
12/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

13130

Study information

Scientific title

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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13130

On 06/03/2014 the anticipated end date was changed from 01/07/2013 to 01/09/2014.

Ethics approval

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

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2012

Overall trial end date

01/09/2014

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.poole.nhs.uk/

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Society (UK)

Alternative name(s)

MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24812193

Publication citations

  1. Protocol

    Thomas S, Fazakarley L, Thomas PW, Brenton S, Collyer S, Perring S, Scott R, Galvin K, Hillier C, Testing the feasibility and acceptability of using the Nintendo Wii in the home to increase activity levels, vitality and well-being in people with multiple sclerosis (Mii-vitaliSe): protocol for a pilot randomised controlled study., BMJ Open, 2014, 4, 5, e005172, doi: 10.1136/bmjopen-2014-005172.

Additional files

Editorial Notes