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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222300




Registration number
NCT00222300
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
8/08/2006

Titles & IDs
Public title
A Targeted Strengthening Program Following Total Hip Replacement.
Scientific title
A Targeted Strengthening Program Following Total Hip Replacement.
Secondary ID [1] 0 0
H2002/01532
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Joint Replacement 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lower limb strength using a step test
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Pain, stiffness and function using the WOMAC questionnaire.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Function using the Timed Up-and-Go Test.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life using the AQoL
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Spatiotemporal measures of walking using an instrumented mat.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Hip joint torques using 3-D motion analysis.
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
* primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
* able to walk 45m independently with or without walking aid.
* able to comprehend instructions
* prior joint replacement on the other side at least 12 months previously
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unable to fully weight-bear on affected limb
* pre-existing neurological or orthopaedic condition affecting gait
* revision surgery
* post-operative complications, e.g. wound infection
* uncontrolled systemic disease

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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
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)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Mary P Galea, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00222300