title: 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.
abstract: BACKGROUND
  The benefits of physical activity for people with multiple sclerosis (pwMS) have been recognised. However, exercise regimens can be difficult to maintain over the longer term and pwMS may face unique barriers to physical activity engagement. Pilot research suggests the Nintendo Wii can be used safely at home by pwMS with minimal mobility/balance issues and may confer benefits. We have developed a home-based physiotherapist supported Wii intervention ('Mii-vitaliSe') for pwMS that uses commercial software. This is a pilot study to explore the feasibility of conducting a full scale clinical and cost-effectiveness trial of Mii-vitaliSe.
  
  
  METHODS
  30 ambulatory, relatively inactive pwMS will be randomised to receive Mii-vitaliSe immediately, or after 6 months. Outcomes, measured at baseline and 6 and 12 months later, will include balance, gait, mobility, hand dexterity and self-reported physical activity levels, fatigue, self-efficacy, mood and quality of life. Interviews conducted on a purposive sample of participants will explore experiences of participation in the study and barriers and facilitators to using the Wii. Mean recruitment, adherence rate and standard deviations (SDs) of potential primary outcomes for the full trial will be estimated and precision summarised using 95% confidence intervals (CIs). Interview transcripts will be thematically analysed using a generic qualitative approach.
  
  
  BACKGROUND
  National Health Service (NHS; ref 12/SC/0420) and university ethical approvals have been obtained as has NHS Research and Development permission from the relevant trust. A home risk assessment will be undertaken for all potential participants. All adverse events will be closely monitored, documented and reported to the study Safety Monitoring Committee. At least one publication in a peer reviewed journal will be produced and research findings presented at a national and international conference. With service users, we will coproduce a summary of the findings for dissemination on our research unit's website and elsewhere.
  
  
  BACKGROUND
  ISRCTN 49286846.
authors.affiliation: Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Thomas
authors.forename: Louise
authors.initials: L
authors.lastname: Fazakarley
authors.forename: Peter W
authors.initials: PW
authors.lastname: Thomas
authors.forename: Sarah
authors.initials: S
authors.lastname: Brenton
authors.forename: Sarah
authors.initials: S
authors.lastname: Collyer
authors.forename: Steve
authors.initials: S
authors.lastname: Perring
authors.forename: Rebecca
authors.initials: R
authors.lastname: Scott
authors.forename: Kathleen
authors.initials: K
authors.lastname: Galvin
authors.forename: Charles
authors.initials: C
authors.lastname: Hillier
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology*; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D009103:Multiple Sclerosis / Q000523:psychology / Q000534:rehabilitation*; D010045:Outpatients / Q000523:psychology*; D010865:Pilot Projects; D011788:Quality of Life; D020377:Self Efficacy; D013997:Time Factors; D063367:Virtual Reality Exposure Therapy / Q000379:methods*
keywords: Rehabilitation Medicine