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Trial registered on ANZCTR


Trial ID
ACTRN12605000143628
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
15/08/2005
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical trial of joint mobilisation after ankle fracture
Scientific title
The effectiveness and cost-effectiveness of joint mobilisation after cast immobilisation for ankle fracture
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fracture 233 0
Condition category
Condition code
Injuries and Accidents 264 264 0 0
Fractures
Physical Medicine / Rehabilitation 2406 2406 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental intervention: 4 weeks of twice weekly physiotherapy passive joint mobilisation + home exercise program
Intervention code [1] 147 0
Rehabilitation
Intervention code [2] 2026 0
Treatment: Other
Comparator / control treatment
Control intervention: 4 weeks of home exercise program
Control group
Active

Outcomes
Primary outcome [1] 313 0
Lower Extremity Functional Scale
Timepoint [1] 313 0
Follow-up at 4, 12 & 24 weeks
Primary outcome [2] 314 0
Assessment of Quality of Life
Timepoint [2] 314 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [1] 695 0
Return to work and leisure/sport/recreation activities
Timepoint [1] 695 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [2] 696 0
Pain (VAS) on equal weight-bearing and stairs
Timepoint [2] 696 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [3] 697 0
Walking speed and step length asymmetry
Timepoint [3] 697 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [4] 698 0
Stair climbing rate
Timepoint [4] 698 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [5] 699 0
Ankle dorsiflexion range of motion
Timepoint [5] 699 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [6] 700 0
Global perceived effect of treatment scale
Timepoint [6] 700 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [7] 701 0
Satisfaction with physiotherapy treatment
Timepoint [7] 701 0
Follow-up at 4, 12 & 24 weeks
Secondary outcome [8] 702 0
Number of days to pain-free walking
Timepoint [8] 702 0
Follow-up at 4, 12 & 24 weeks

Eligibility
Key inclusion criteria
Ankle fracture treated with cast immobilisation +/- surgerycast removed in the preceding 7 days, approval to partial weight-bear or weight-bear as tolerated referral for outpatient physiotherapy, >2/10 ankle pain when 50% of body weight is on the affected legfull skeletal growth, no concurrent and significant injury or illness, available for 6 months.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
sealed, opaque, and consecutively numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 321 0
Government body
Name [1] 321 0
The Motor Accidents Authority of NSW
Address [1] 321 0
Level 25, 580 George Street
Sydney NSW 2000, Australia
Country [1] 321 0
Australia
Funding source category [2] 2567 0
Other Collaborative groups
Name [2] 2567 0
NSW Institute of Sport
Address [2] 2567 0
Building B, Level 1
6 Figtree Drive
Sydney Olympic Park NSW 2127
AUSTRALIA
Country [2] 2567 0
Australia
Primary sponsor type
Individual
Name
Dr Anne Moseley
Address
Discpline of Physiotherapy, The University of Sydney
Country
Australia
Secondary sponsor category [1] 249 0
Individual
Name [1] 249 0
A/Prof Rob Herbert
Address [1] 249 0
Discpline of Physiotherapy, The University of Sydney
Country [1] 249 0
Australia
Secondary sponsor category [2] 250 0
Individual
Name [2] 250 0
Prof Kathryn Refshauge
Address [2] 250 0
Discpline of Physiotherapy, The University of Sydney
Country [2] 250 0
Australia
Secondary sponsor category [3] 251 0
Individual
Name [3] 251 0
A/Prof Marion Haas
Address [3] 251 0
Centre for Health Economics Research and Evaluation
Country [3] 251 0
Australia
Secondary sponsor category [4] 252 0
Individual
Name [4] 252 0
Christine Lin
Address [4] 252 0
Discpline of Physiotherapy, The University of Sydney
Country [4] 252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1229 0
University of Sydney
Ethics committee address [1] 1229 0
Ethics committee country [1] 1229 0
Australia
Date submitted for ethics approval [1] 1229 0
Approval date [1] 1229 0
Ethics approval number [1] 1229 0
Ethics committee name [2] 1230 0
Northern Sydney Health Human Research Ethics Committee
Ethics committee address [2] 1230 0
Ethics committee country [2] 1230 0
Australia
Date submitted for ethics approval [2] 1230 0
Approval date [2] 1230 0
Ethics approval number [2] 1230 0
Ethics committee name [3] 1231 0
Sydney South West Area Health Service
Ethics committee address [3] 1231 0
Ethics committee country [3] 1231 0
Australia
Date submitted for ethics approval [3] 1231 0
Approval date [3] 1231 0
Ethics approval number [3] 1231 0
Ethics committee name [4] 1232 0
St Vincent's Public Hospital
Ethics committee address [4] 1232 0
Ethics committee country [4] 1232 0
Australia
Date submitted for ethics approval [4] 1232 0
Approval date [4] 1232 0
Ethics approval number [4] 1232 0

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

Contacts
Principal investigator
Name 35403 0
Address 35403 0
Country 35403 0
Phone 35403 0
Fax 35403 0
Email 35403 0
Contact person for public queries
Name 9336 0
Dr Anne Moseley
Address 9336 0
School of Physiotherapy
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9336 0
Australia
Phone 9336 0
+61 2 93519547
Fax 9336 0
+61 2 93519278
Email 9336 0
amoseley@mail.usyd.edu.au
Contact person for scientific queries
Name 264 0
Dr Anne Moseley
Address 264 0
School of Physiotherapy
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 264 0
Australia
Phone 264 0
+61 2 93519547
Fax 264 0
+61 2 93519278
Email 264 0
amoseley@mail.usyd.edu.au