Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000599077
Ethics application status
Approved
Date submitted
22/07/2010
Date registered
23/07/2010
Date last updated
16/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gait and postural control to change the knee loading in patients with knee osteoarthritis (OA).
Scientific title
In patients with medial tibiofemoral osteoarthritis, is gait retraining more effective than a wait-list control in reducing loading on the medial side?
Secondary ID [1] 252267 0
Nil
Universal Trial Number (UTN)
Trial acronym
GO Study (Gait and Osteoarthritis)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 257788 0
Condition category
Condition code
Musculoskeletal 257960 257960 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gait retraining intervention: 1) 2x30min session each week at University of Sydney, for 4 weeks, in the 3D motion analysis laboratory 2) The participant walks on a 5m force platform, each gait trial does not exceed 6-8seconds. 3) The participant is given full real-time feedback during the training, so that they are aware of their incorrect walking style. 4) A light-feedback system is set up for the participant so that while they walk, a flash would indicate that they had achieved a sub-optimal knee adduction moment (KAM) during their gait trial. The light would point toward an incorrect walking style. The light is used in this way, to reduce dependence of the subject to have the light on, whilst performing correct gait style. 5) The subject performs this optimal movement 10 times followed by a rest, with the data collector asking after each trial, using a Likert pain scale, if they felt any pain in the knee during the activity. 30 trials are undertaken altogether (3 x 10 trials). There is no specific movement that is taught, each participant will adjust their gait style on their own advice and if the light does not flash, it indicates that they are walking correctly. However, if the participant fails to keep the light off, then suggestions are made to reduce the KAM eg: walking with toes out, by the assessor.
Intervention code [1] 256854 0
Rehabilitation
Intervention code [2] 256863 0
Treatment: Other
Comparator / control treatment
The wait-list control group will receive the similar intervention as the training groups after 4 weeks, not 12.
Control group
Active

Outcomes
Primary outcome [1] 258826 0
Knee adduction moment. Will be measured using Biomechanical software, Cortex 2.0 in a 3D Motion analysis lab.
Timepoint [1] 258826 0
It is taken at baseline, and then re-assessed at 6 weeks post intervention.
Secondary outcome [1] 264929 0
The Westren Ontario and McMaster Universities index (WOMAC) is used to assess knee pain and function at baseline and at the end of the intervention.
Timepoint [1] 264929 0
At baseline and at the end of the intervention.

Eligibility
Key inclusion criteria
Must have medial knee OA in at least one knee
Good general health
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any form of secondary arthritis such as gout, pseudogout etc
Joint injury (unrepaired anterior cruciate ligament injury), injection or surgery within the past 6 months or knee joint replacement.
Knee cartilage surgery
Knee injections (e.g. Corticosteroids – cortisone); no more than 2 in the last 5 years, and only one in the last 6 months.
Acute or terminal illness
Severe functional limitation (unable to walk unaided)

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)
Participants are communtiy dwelling, and once enrolled and have completed all baseline assessments, an external research assistant (not involved in the study), will randomly allocate groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Will use blocking randomisation using randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257314 0
University
Name [1] 257314 0
University of Sydney
Country [1] 257314 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Cumberland Campus
PO Box 170, 75 East Street, Lidcombe NSW, 2141
Country
Australia
Secondary sponsor category [1] 256572 0
None
Name [1] 256572 0
Address [1] 256572 0
Country [1] 256572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259341 0
Human research ethics committee
Ethics committee address [1] 259341 0
Office of ethics administration
Level 6
Jane Foss Russell Building, G02
The University of Sydney, NSW, 2006
Ethics committee country [1] 259341 0
Australia
Date submitted for ethics approval [1] 259341 0
07/04/2010
Approval date [1] 259341 0
28/04/2010
Ethics approval number [1] 259341 0

Summary
Brief summary
The primary hypothesis is that participants randomised to the 1 month gait training program will reduce KAM and improve symptoms of OA compared to the control group. Osteoarthritis is the most common musculoskeletal disorder affecting Australians and is the leading cause of pain and disability. OA is caused by rapid degeneration of articular cartilage. Knee osteoarthritis reduces physical activity level due to the associated pain, impaired gait and balance and lower-extremity muscle weakness. Osteoarthritis treatment is typically driven by a pharmacologic approach to provide analgesia and reduce inflammation, rather than employment of disease-modifying agents, or risk factor reduction, with knee replacement surgery the only option in advanced cases. Gait retraining and postural control is theoretically far more targeted to the impairments in knee OA. The primary hypothesis that participants randomised in the 1 month gait program will have a significant reduction in the KAM compared to the control group, and have a significant improvement in symptoms of OA such as pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31418 0
Address 31418 0
Country 31418 0
Phone 31418 0
Fax 31418 0
Email 31418 0
Contact person for public queries
Name 14665 0
Jinan Dib
Address 14665 0
PO Box 170, 75 East Street, Lidcombe NSW 2141
Country 14665 0
Australia
Phone 14665 0
+61410 881 178
Fax 14665 0
Email 14665 0
jdib5450@uni.sydney.edu.au
Contact person for scientific queries
Name 5593 0
Prof Maria Fiatarone Singh
Address 5593 0
PO Box 170, 75 East Street, Lidcombe NSW 2141
Country 5593 0
Australia
Phone 5593 0
+61 2 9351 9755
Fax 5593 0
Email 5593 0
m.singh@usyd.edu.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.