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
Protocol serial number	13130
Sponsor	Poole Hospital NHS Foundation Trust (UK)
Funder	Multiple Sclerosis Society (UK)

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 of protocol

Not provided at time of registration

Contact information

Dr Sarah Thomas
Scientific

Bournemouth University
Royal London House
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom

Email	saraht@bournemouth.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Demographic/descriptor variables measured at baseline and 6 months
Key secondary outcome measure(s)	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
Completion date	01/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	01/11/2012
Date of final enrolment	01/09/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Bournemouth University

Bournemouth
BH1 3LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	27/09/2017		Yes	No
Protocol article	protocol	07/05/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.