Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000291987
Ethics application status
Approved
Date submitted
16/03/2011
Date registered
21/03/2011
Date last updated
20/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
TKR Patient Outcomes using Wii Enhanced Rehabilitation
Scientific title
A Prospective Randomized Controlled Trial comparing standard rehabilitation versus additional exercises using the Nintendo Wii-Fit following Total Knee Replacement in patients who have undergone a primary unilateral total knee replacement.
Secondary ID [1] 259778 0
Nil
Universal Trial Number (UTN)
U1111-1119-9907
Trial acronym
TKR-POWER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 261362 0
Condition category
Condition code
Musculoskeletal 259522 259522 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks of Nintendo Wii-Fit exercises at home performed using the Wii console and the Wii-Fit software and balance board. The exercises will be selected from the Wii-Fit software and prescribed in increasing difficulty through the phases - 6-8 weeks, 8-12 weeks and 12-18 weeks.
Prescribed at least three times a week for 30 minutes per session.
The subjects in both groups will maintain an exercise diary of all exercises performed and physiotherapy attendances. The Wii also records all exercises performed.
Any physiotherapy attendance will be at the recommendation of the rehabilitation staff on discharge from in-patient rehabilitation or at the request of the treating surgeon.
Both groups will receive a phone call in the first week of the 12 week intervention period to answer questions and check progress. Further phone-calls will be scheduled as necessary.
Intervention code [1] 264213 0
Rehabilitation
Comparator / control treatment
Standard treatment - The standard rehabilitation protocols used by each participating surgeon.
The subjects in both groups will maintain an exercise diary of all exercises performed and physio attendances.
Any physiotherapy attendance will be at the recommendation of the rehabilitation staff on discharge from in-patient rehabilitation or at the request of the treating surgeon.
Both groups will receive a phone call in the first week of the 12 week intervention period to answer questions and check progress. Further phonecalls will be scheduled as necessary.
Control group
Active

Outcomes
Primary outcome [1] 262322 0
The difference in functional outcome between the two groups as assessed by WOMAC score.
Timepoint [1] 262322 0
18 weeks and 1 year
Secondary outcome [1] 273539 0
Subjective improvement in joint specific functional outcome measured by Oxford knee score
Timepoint [1] 273539 0
18 weeks and 1 year
Secondary outcome [2] 273576 0
Strength of knee flexors and extensors assessed by handheld dynanometry
Timepoint [2] 273576 0
18 weeks and 1 year
Secondary outcome [3] 273577 0
Balance assessed by double leg and single leg stances on Biodex balance SD and Nintendo Wii
Timepoint [3] 273577 0
18 weeks and 1 year
Secondary outcome [4] 273578 0
General health status assessed by SF-12 questionnaire
Timepoint [4] 273578 0
18 weeks and 1 year
Secondary outcome [5] 273579 0
Patient satisfaction assessed by questionnaire
Timepoint [5] 273579 0
18 weeks and 1 year
Secondary outcome [6] 273580 0
American knee society objective score measuring knee joint alignment and range of motion.
Timepoint [6] 273580 0
18 weeks and 1 year
Secondary outcome [7] 294160 0
Visual analogue score of pain
Timepoint [7] 294160 0
6 weeks, 18 weeks, 1 year
Secondary outcome [8] 294161 0
Hospital Anxiety and Depression score - HADS
Timepoint [8] 294161 0
6 weeks, 18 weeks and 1 year
Secondary outcome [9] 294162 0
Locus of Control score - patient reported questionnaire
Timepoint [9] 294162 0
6 weeks, 18 weeks and 1 year

Eligibility
Key inclusion criteria
Primary, unilateral total knee replacement
English speaking
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological or inner ear balance disorders
Bilateral knee replacements.
Unicondylar knee replacements
Dementia

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)
The decision to include the patient in the trial is made before the patient is allocated to a group. The allocation is made using sequentially-numbered, sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In answer to the query above on blinding. The prinicipal investigator will know the group allocation but the research staff taking the measurements will not.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3864 0
2067
Recruitment postcode(s) [2] 3865 0
2065

Funding & Sponsors
Funding source category [1] 264660 0
Self funded/Unfunded
Name [1] 264660 0
Jonathan Negus
Country [1] 264660 0
Australia
Funding source category [2] 264674 0
Other Collaborative groups
Name [2] 264674 0
Sydney Orthopaedic Research Institute
Country [2] 264674 0
Australia
Funding source category [3] 264675 0
Charities/Societies/Foundations
Name [3] 264675 0
Royal Australasian College of Surgeons
Country [3] 264675 0
Australia
Primary sponsor type
Individual
Name
Jonathan Negus
Address
Sydney Orthopaedic Research Institute
Level 1 The Gallery
445 Victoria Avenue
Chatswood
NSW
2067
Country
Australia
Secondary sponsor category [1] 263798 0
Individual
Name [1] 263798 0
Professor Lyn March
Address [1] 263798 0
Department of Rheumatology
Reserve road
North Shore Hospital
St Leonard's
NSW
2065
Country [1] 263798 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266668 0
Northern Sydney Central Coast Health HREC
Ethics committee address [1] 266668 0
Ethics committee country [1] 266668 0
Australia
Date submitted for ethics approval [1] 266668 0
Approval date [1] 266668 0
16/11/2010
Ethics approval number [1] 266668 0
1010-338M

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

Contacts
Principal investigator
Name 32342 0
Address 32342 0
Country 32342 0
Phone 32342 0
Fax 32342 0
Email 32342 0
Contact person for public queries
Name 15589 0
Dr Jonathan Negus
Address 15589 0
SORI
Level 1, The Gallery
445 Victoria Avenue
Chatswood
NSW 2067
Country 15589 0
Australia
Phone 15589 0
+61 2 9904 7182
Fax 15589 0
Email 15589 0
[email protected]
Contact person for scientific queries
Name 6517 0
Dr Jonathan Negus
Address 6517 0
SORI
Level 1, The Gallery
445 Victoria Avenue
Chatswood
NSW 2067
Country 6517 0
Australia
Phone 6517 0
+61 2 9904 7182
Fax 6517 0
Email 6517 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
New Record*ThesisYes file:///Users/jonathan/Downloads/NEGUS%20Jonathan%... [More Details] NEGUS Jonathan - final thesis.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePatient outcomes using Wii-enhanced rehabilitation after total knee replacement - the TKR-POWER study.2015https://dx.doi.org/10.1016/j.cct.2014.11.007
N.B. These documents automatically identified may not have been verified by the study sponsor.