|
ISRCTN
|
ISRCTN06807619
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does the use of Nintendo WiiTM Sports improve dominant arm function and is it acceptable to patients after stroke?
|
|
Scientific title
|
|
|
Acronym
|
Trial of WiiTM in STroke TWIST
|
|
Serial number at source
|
11030
|
|
Study hypothesis
|
The aim of this research study is to find out whether people who have arm weakness after a stroke can benefit from exercising with a Nintendo WiiTM for six weeks in addition to their usual rehabilitation programme. We would like to recruit two hundred and forty people who have weakness in the dominant arm this means the arm they used to do most things like writing or using a knife. We want to find out if using the WiiTM improves arm function, how the participants feel about using it and if this use can reduce costs for the health service over time. Patients are likely to be approached about the study in hospital or a clinic following a stroke but the rest of the study will take place in their own homes, except for the 6 week and 6 months follow-up visits which can take place either in patients home, or in outpatient clinic or research unit at the convenience of the participant. The WiiTM game and console will be lent to 120 participants to use at home with their own TV to exercise their arm for six weeks. The other 120 will be taught personalised arm exercises. Both groups will be asked to exercise daily for six weeks. There are questionnaires & simple, painless tests at the start, after six weeks and again after six months. Twenty five of the participants who have a WiiTM for six weeks may be asked for a further interview to make sure the researchers understand fully how using the WiiTM affected their condition. In all cases, the study should last no more than six months. This study will be conducted in a number of stroke centres in the South West of England and is supported by a NIHR Research for Patient Benefit Grant.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
11/SC/0405
|
|
Study design
|
Randomised; Interventional; Design type: Not specified
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used
|
|
Participants - inclusion criteria
|
1. Clinical diagnosis of new stroke within the previous six months at time of consent
2. Aged 18 years or older
3. Participants living at home at the start of their participation in study with suitable home environment (consider enough space, plus suitable TV, electricity supply and telephone)
4. Weakness in the dominant arm Medical Research Council (MRC) scale less than 5 in any joint plane of movement) due to stroke
6. Able to manipulate WiiTM remote control
7. Able to understand and follow two stage commands and able to give written or verbal consent.; Target Gender: Male & Female ; Lower Age Limit 18 years
|
|
Participants - exclusion criteria
|
1. Comorbidity which impairs ability to participate (e.g. severe arthritis, severe cognitive impairment, severe cardiorespiratory
disease)
2. Hemianopia or visual inattention
3. Concurrent participation in another interventional study
4. Pacemaker or Implantable cardioverter defibrillator (ICD) device (possible interference from the WiiTM)
5. In, or likely to be discharged to, long term care
|
|
Anticipated start date
|
01/11/2011
|
|
Anticipated end date
|
31/07/2013
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
|
|
Target number of participants
|
Planned Sample Size: 240; UK Sample Size: 240
|
|
Interventions
|
Participants advised to undertake up to 45 minutes of exercises using the Nintendo WiiTM daily for six weeks at home
|
|
Primary outcome measure(s)
|
Arm Strength and function as measured by the Action Research Arm Test at six weeks
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
National Institute for Health Research (NIHR) (UK)- Research for Patient Benefit Grant (Ref. pb-pg-0110-20332)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Katja
Adie
|
|
Address
|
Treliske
|
|
City/town
|
Truro
|
|
Zip/Postcode
|
TR1 3LJ
|
|
Country
|
United Kingdom
|
|
Email
|
katja.adie@rcht.cornwall.nhs.uk
|
|
Sponsor
|
Royal Cornwall Hospitals NHS Trust (UK)
|
|
Address
|
Treliske
|
|
City/town
|
Truro
|
|
Zip/Postcode
|
TR1 3LJ
|
|
Country
|
United Kingdom
|
|
Date applied
|
25/11/2011
|
|
Last edited
|
25/11/2011
|
|
Date ISRCTN assigned
|
25/11/2011
|
