Condition category
Circulatory System
Date applied
25/11/2011
Date assigned
25/11/2011
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke occurs when the blood supply to part of the brain is cut off. The injury to the brain can lead to weakness or paralysis in one side of the body. The aim of this 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 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.

Who can participate?
Stroke patients aged 18 and over who have weakness in their dominant arm (the arm they used to do most things like writing or using a knife).

What does the study involve?
Patients are approached about the study in hospital or a clinic following a stroke but the rest of the study takes place in their own homes, except for the 6-week and 6-month follow-up visits which take place either in the patient’s home or in the outpatient clinic or research unit at the convenience of the participant. Participants are randomly allocated to one of two groups. Participants in one group each receive a WiiTM game and console to use at home with their own TV to exercise their arm for six weeks. Participants in the other group are taught personalised arm exercises. Both groups are asked to exercise daily for six weeks. There are questionnaires and simple, painless tests at the start, after 6 weeks and again after 6 months. Twenty five of the participants who use a WiiTM for 6 weeks may be asked for a further interview so that we can understand fully how using the WiiTM affected their condition. In all cases, the study should last no more than 6 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
This study is conducted in a number of stroke centres in the South West of England.

When is the study starting and how long is it expected to run for?
November 2011 to July 2013

Who is funding the study?
NIHR Research for Patient Benefit Grant (UK)

Who is the main contact?
Dr Katja Adie
katja.adie@rcht.cornwall.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katja Adie

ORCID ID

Contact details

Treliske
Truro
TR1 3LJ
United Kingdom
-
katja.adie@rcht.cornwall.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11030

Study information

Scientific title

Does the use of Nintendo WiiTM Sports improve dominant arm function and is it acceptable to patients after stroke?

Acronym

Trial of WiiTM in STroke (TWIST)

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.

Ethics approval

11/SC/0405

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Arm strength and function as measured by the Action Research Arm Test at six weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2011

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 240

Participant 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

Recruitment start date

01/11/2011

Recruitment end date

31/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Treliske
Truro
TR1 3LJ
United Kingdom

Sponsor information

Organisation

Royal Cornwall Hospitals NHS Trust (UK)

Sponsor details

Treliske
Truro
TR1 3LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Grant (ref. pb-pg-0110-20332)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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/25336985
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25125442
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26975313

Publication citations

  1. Protocol

    Adie K, Schofield C, Berrow M, Wingham J, Freeman J, Humfryes J, Pritchard C, Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke - TWIST., Int J Gen Med, 2014, 7, 475-481, doi: 10.2147/IJGM.S65379.

  2. Results

    Wingham J, Adie K, Turner D, Schofield C, Pritchard C, Participant and caregiver experience of the Nintendo Wii SportsTM after stroke: qualitative study of the trial of WiiTM in stroke (TWIST), Clin Rehabil, 2015 , 29, 3, 295-305, doi: 10.1177/0269215514542638.

  3. Results

    K Adie, C Schofield, M Berrow, J Wingham, J Humfryes, C Pritchard, M James, R Allison, Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: A randomized controlled trial and economics analysis, Clin Rehabil, 2016, doi: 10.1177/0269215516637893.

Additional files

Editorial Notes

15/03/2016: Publication reference added.