Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000875000
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
18/10/2010
Date last updated
12/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Nintendo Wii following an acquired brain injury
Scientific title
Endurance and balance following exercise using Nintendo Wii in adults with an acquired brain injury.
Secondary ID [1] 252876 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 258406 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258572 258572 0 0
Physiotherapy
Neurological 258597 258597 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study design. All participants will complete both the intervention and comparator treatment.

During the intervention, participants will receive 4 weeks, 3 x 30 minute sessions per week of exercise using Nintendo Wii-Fit games and activities. Games and activities will be selected from the Wii suite relevant to participant deficits and interests. The experimental group will continue to receive usual physiotherapy rehabilitation. Due to clinical contrainsts there will no formal washout period. However, it is anticipated that up to 5 days washout period will occur.
Intervention code [1] 257403 0
Rehabilitation
Comparator / control treatment
During the comparator treatment participants will receive 4 weeks of usual physiotherapy rehabilitation. Usual physiotherapy consists of an individualised treatment program comprising typically daily physiotherapy targeting participant impairments and activity limitations using a combination of motor relearning and Bobath approaches.
Control group
Active

Outcomes
Primary outcome [1] 259417 0
Endurance will be measured using distance walked in 6 minutes (6 minute walk test)
Timepoint [1] 259417 0
Baseline, at completion of both 4-week blocks of therapy, experimental and control blocks.
Secondary outcome [1] 265958 0
Balance will be measured using the Balance Outcome Measure for Elder Rehabilitation (BOOMER)
Timepoint [1] 265958 0
Baseline, at completion of both 4-week blocks of therapy, experimental and control blocks.
Secondary outcome [2] 265959 0
Gait speed will be measured using a GaitRITE system
Timepoint [2] 265959 0
Baseline, at completion of both 4-week blocks of therapy, experimental and control blocks.
Secondary outcome [3] 265960 0
Motivation to rehabilitation will be measuring using questionnaires using a Likert scale
Timepoint [3] 265960 0
Baseline, at completion of both 4-week blocks of therapy, experimental and control blocks.
Secondary outcome [4] 266008 0
High level mobility will be measured using the HiMat
Timepoint [4] 266008 0
Baseline, at completion of both 4-week blocks of therapy, experimental and control blocks.

Eligibility
Key inclusion criteria
(1) have sustained an acquired brain injury,
(2) be able to walk at least 10m with supervision (with or without an aid),
(3) have the ability to understand and follow simple instructions and
(4) be receiving rehabilitation at the BIRU for the entire intervention period.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) behavioural problems affecting participation in sessions, (2) uncontrolled health conditions or
(3) severe visual, vestibular or orthopaedic problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be approached by treating physiotherapist. The study will be explained to them, opportunity will be provided to have questions answered, information sheet will be provided. If screened as suitable to participate and willing to volunteer, participants will sign the consent
form. After initial baseline measures participants will be
allocated to either experimental or control intervention first using block allocation. Block allocation sequence will be determined by investigator not involved in recruitment and is reliant on availability of research assistant to deliver the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once first participant was recruited, block allocation sequence commenced. Research assistant availability determined the first 5-week block of eligible participants recruited to recieve the control treatment first and the second to receive the intervention treatment first. Subsequent block allocations will be determined by further research assistant availability and clinical caseload and timeframes as identified by the treating physiotherapist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Intention to treat analysis
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2010
Actual
12/04/2010
Date of last participant enrolment
Anticipated
Actual
30/03/2011
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
25
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257840 0
Hospital
Name [1] 257840 0
The Princess Alexandra Hospital
Country [1] 257840 0
Australia
Primary sponsor type
Hospital
Name
The Princess Alexandra Hospital
Address
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 257046 0
None
Name [1] 257046 0
Address [1] 257046 0
Country [1] 257046 0
Other collaborator category [1] 251578 0
University
Name [1] 251578 0
University of Queensland
Address [1] 251578 0
St Lucia QLD 4072
Country [1] 251578 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259875 0
Princess Alexandra Hospital
Ethics committee address [1] 259875 0
Ethics committee country [1] 259875 0
Australia
Date submitted for ethics approval [1] 259875 0
Approval date [1] 259875 0
30/03/2010
Ethics approval number [1] 259875 0
HREC/09/QPAH/309
Ethics committee name [2] 259876 0
The University of Queensland
Ethics committee address [2] 259876 0
Ethics committee country [2] 259876 0
Australia
Date submitted for ethics approval [2] 259876 0
Approval date [2] 259876 0
15/04/2010
Ethics approval number [2] 259876 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31775 0
Address 31775 0
Country 31775 0
Phone 31775 0
Fax 31775 0
Email 31775 0
Contact person for public queries
Name 15022 0
Ms Janelle Gesch
Address 15022 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 15022 0
Australia
Phone 15022 0
61 7 31762401
Fax 15022 0
Email 15022 0
[email protected]
Contact person for scientific queries
Name 5950 0
Suzanne Kuys
Address 5950 0
The Allied Health Research Collobarative
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country 5950 0
Australia
Phone 5950 0
61 7 31396319
Fax 5950 0
Email 5950 0
[email protected]

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.