Condition category
Not Applicable
Date applied
23/02/2016
Date assigned
04/03/2016
Last edited
23/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There were 64,7721 A&E attendances and 20,4424 admissions to hospital for fall-related injuries in people over the age of 60 years in 2000. The cost of these falls to the NHS is approximately £980 million per year. For north Essex (the area where this study takes place) the cost of falls is approximately £5 million per year. To combat recurrent falls Colchester Hospital University Trust (CHUFT) runs a falls clinic. The training lasts for 9 weeks (1 hour session per week), it is patient specific and it aims, among other things, to improve balance. The training commonly incorporates the use of the Nintendo WiiFit™. A previous study was undertaken using the Wii as a training tool for fallers attending hospital as outpatients mainly to assess its safety. This study will test the effectiveness of the Wii in patients' homes. Undertaking supervised training in the home will reduce the burden placed upon patients by requiring them to come to the hospital for an extra training session. This will also enable to intervention to be made available to more people.

Who can participate?
Recurrent fallers aged 60 or over, assessed by physiotherapy staff as being suitable to attend the falls prevention training

What does the study involve?
Participants are randomly allocated to one of three groups. Group A is given physiotherapy falls training at the hospital. Group B is given extra Wii balance training by a physiotherapist/physiotherapist assistants. Group C is given an extension of the current hospital training with physiotherapy staff supervising, correcting and progressing patients. The extra training for groups B and C consists of 20­-45 minutes supervised training twice per week in the patient's home. We compare the functional mobility and psychological wellbeing of all patients before and after training

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

Where is the study run from?
Colchester Hospital University Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2016 to March 2017

Who is funding the study?
Post Graduate Medical Charity at Colchester Hospital University NHS Foundation Trust (UK)

Who is the main contact?
Dr Murray Griffin

Trial website

Contact information

Type

Scientific

Primary contact

Dr Murray Griffin

ORCID ID

Contact details

University of Essex
Wivenhoe Park
Colchester
CO4 3RL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Using the Nintendo Wii as an intervention for elderly fallers: a randomised controlled trial

Acronym

Study hypothesis

1. Wii training will reduce the incidence of falls, improve balance, functional mobility, physical activity and psychological wellbeing.
2. Using the Wii at home will improve compliance and reduce drop out rates (which have been significant) but with no compromise on the efficacy of the treatment.

Ethics approval

IRAS approved 14/EE/1182

Study design

Single-centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Condition

Elderly fallers

Intervention

10 week training program RCT with 30 patients randomly allocated to one of three conditions plus 3 month follow up:

Group A will be given physiotherapy falls training at the hospital (‘hospital only group’ ).
Group B will be given extra Wii balance training by a physiotherapist/physiotherapist assistants (‘ Wii group’).
Group C will be an extension of the current hospital training with physiotherapy staff supervising, correcting and progressing patients (‘non-Wii group’)

The extra training for groups B and C will consist of 20-45 min supervised training twice per week in the patient's home.
We will then compare functional mobility and psychological wellbeing of these patients before and after training

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Incidence of falling

Secondary outcome measures

1. Timed get up and go test (TUG)
2. Turn 180° test
3. Functional reach test
4. Single leg balance test
5. Patients' gait will also be assessed by measuring walking speed over a 10 m course
6. Psychological wellbeing and quality of life

Overall trial start date

01/03/2016

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Potential participants will comprise recurrent fallers aged 60 + years, assessed by physiotherapy staff as being suitable to attend the falls prevention training
2. They must be able to stand/ambulate with minimal assistance (i.e., walking stick/frame)
3. They will be identified by physiotherapy staff at falls prevention training assessments and referred to the study via falls clinic at CHUFT or from the multidisciplinary falls prevention service in the community

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Any patient who has a Wii at home or regularly uses the Wii
2. Patients who are unable to stand/walk without physical assistance
3. Patients who are unable to follow instructions e.g., due to dementia
4. Patients with significant visual impairment who are unable to see the TV screen
5. Patients who may feel dizzy during the Wii exercise e.g., due to vestibular problems
6. Patients with pacemakers will be excluded because even though the Wii has been reported to 'seem safe with pacemakers' (Rajani et al 2008), Nintendo state that the Wii console and Wii Remote can emit radio waves that can affect the operation of nearby electronics, including cardiac pacemakers. Therefore these patients will be excluded

Recruitment start date

01/03/2016

Recruitment end date

01/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Colchester Hospital University Foundation Trust
CO4 5JL
United Kingdom

Sponsor information

Organisation

University of Essex (UK)

Sponsor details

c/o Ms Sarah Manning­
Press Research and Enterprise Office
Colchester
CO4 3SQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Post Graduate Medical Charity at Colchester Hospital University NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes