Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000535077
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
2/07/2010
Date last updated
2/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wii Intervention in a Geriatric Evaluation Location (WIGEL)
Scientific title
The effect of Nintendo Wii gaming compared with usual mobility practise on balance and functional mobility in frail older people
Secondary ID [1] 252126 0
nil
Universal Trial Number (UTN)
Trial acronym
WIGEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frail older adults 256657 0
Condition category
Condition code
Physical Medicine / Rehabilitation 256815 256815 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of daily therapy for 25 minutes using the Nintendo Wii Fit. The Nintendo Wii Fit is a video game that is connected to the TV. It is an exercise game consisting of activities using a wireless pointer and balance board. It is designed to be a fun new way to exercise and includes activities that are designed to improve strength, balance and fitness. Activities include strength, balance and yoga activities and games such as 'tightrope walking'. The treating physiotherapist will prescribe and implement Wii Fit activities that are appropriate for the patient.Intervention will be provided for 1 month or until discharge from the Geriatric Evaluation Management Unit (GEM).
Intervention code [1] 255891 0
Rehabilitation
Comparator / control treatment
The control group will receive 25 minutes of traditional therapy daily. Traditional therapy may include practise of mobility, transfers and balance exercises and will be administered one-to-one by a physiotherapist.Intervention will be provided for 1 month or until discharge from the Geriatric Evaluation Management Unit (GEM).
Control group
Active

Outcomes
Primary outcome [1] 257679 0
Timed Up and Go (TUG) - A test of basic functional mobility for frail elderly persons
Timepoint [1] 257679 0
At the time of discharge from the Geriatric Evaluation Mangement (GEM) unit and 1 month post discharge
Primary outcome [2] 257680 0
Activities Specific Balance Confidence Scale
Timepoint [2] 257680 0
At the time of discharge from the GEM unit, 1 month post discharge and 6 months after discharge
Secondary outcome [1] 262995 0
Modified Berg Balance Scale
Timepoint [1] 262995 0
At the time of discharge from the GEM unit and 1 month post discharge
Secondary outcome [2] 262996 0
Short Physical Performance Battery
Timepoint [2] 262996 0
At the time of discharge from the GEM unit and 1 month post discharge
Secondary outcome [3] 263002 0
Timed Instrumental Activities of Daily Living (IADL) Scale
Timepoint [3] 263002 0
At the time of discharge from the GEM unit and 1 month post discharge
Secondary outcome [4] 263003 0
Functional Independence Measure
Timepoint [4] 263003 0
At the time of discharge from the GEM unit and 1 month post discharge

Eligibility
Key inclusion criteria
65 years of age or older
Mini Mental State Examination score of 21/30 or more
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not given medical clearance by the treating team to participate
Unable to perform sit-to-stand with only standby assistance
More than 150kg
Poor vision (less than 6/18 on Snellen Chart)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent and baseline measures participants will be randomised to either therapy using the Nintendo Wii Fit or traditional therapy. Randomisation will be managed by a pharmacist external to the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256379 0
University
Name [1] 256379 0
Flinders University
Country [1] 256379 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Department of Rehabilitation and Aged Care
Repatriation General Hospital
Daws Road
Daw Park
SA, 5041
Country
Australia
Secondary sponsor category [1] 251691 0
None
Name [1] 251691 0
Address [1] 251691 0
Country [1] 251691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258443 0
Southern Adelaide Health Service Human Research and Ethics Department
Ethics committee address [1] 258443 0
Southern Adelaide Health Service
Room 2A 221
Flinders Medical Centre Bedford Park SA 5042
Ethics committee country [1] 258443 0
Australia
Date submitted for ethics approval [1] 258443 0
Approval date [1] 258443 0
22/12/2009
Ethics approval number [1] 258443 0
1/09/0366

Summary
Brief summary
The aim of this project is to determine whether therapy using the Nintendo Wii Fit computer game is as effective as practise of more traditional therapy activities for older people in hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30753 0
Address 30753 0
Country 30753 0
Phone 30753 0
Fax 30753 0
Email 30753 0
Contact person for public queries
Name 14000 0
Maria Crotty
Address 14000 0
Department of Rehabilitation and Aged Care
Repatriation General Hospita
Daws Rd, Daw Park
SA 5041
Country 14000 0
Australia
Phone 14000 0
+ 61 8 8276 9666
Fax 14000 0
Email 14000 0
maria.crotty@health.sa.gov.au
Contact person for scientific queries
Name 4928 0
Maria Crotty
Address 4928 0
Department of Rehabilitation and Aged Care
Repatriation General Hospital
Daws Rd, Daw Park
SA 5041
Country 4928 0
Australia
Phone 4928 0
+ 61 8 8276 9666
Fax 4928 0
Email 4928 0
maria.crotty@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.