Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000379718
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
9/04/2013
Date last updated
20/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between limb length discrepancy and Foot Posture Index (FPI).
Scientific title
The relationship between limb length discrepancy (LLD) and Foot Posture Index (FPI) in ambulatory subjects aged 18-65 years with an LLD of five millimetres or greater as diagnosed by the researchers
Secondary ID [1] 282237 0
Nil
Universal Trial Number (UTN)
NIl
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limb length discrepancy 288754 0
Condition category
Condition code
Musculoskeletal 289111 289111 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to evaluate the effects of an Limb Length Discrepancy on foot posture as measured by the Foot Posture Index (FPI). To measure a participant’s limb length discrepancy, a tape measure method (TMM) will be used. This method involves measuring the distance from the centre of the anterior-superior iliac spine (ASIS) to the centre of medial malleolus of the participant by use of a ruled tape. This is done with the patient’s leg externally rotated so that the lateral border of the foot lies as close to the horizontal as is comfortable. The patient will be measured in supine and sitting position in order to standardise the method. Measurement from the ASIS is a semi-intrusive measurement, requiring participants to lift their shirt so that the ASIS may be palpated; however this is a routine measure which is widely used in clinical practice. When performed by trained professionals, measurement by the TMM should cause minimal patient alarm or discomfort.
The FPI is measured with the subject standing. An FPI is performed by measuring six scoring criteria and giving a score of -2 to +2 on a 5 item scale (where positive scores represent more pronated characteristics).The six clinical criteria used in scoring an FPI are: talar head palpation, supra and infra lateral malleolar curvature, calcaneal frontal plane position, talonavicular joint prominence, congruence of the medial longitudinal arch, and abduction/adduction of the forefoot compared to the rearfoot. The six scores are summed, with high positive values indicating a significantly pronated foot; high negative a supinated one and values close to zero showing a foot near neutral position. The measurements are estimted to take 15 minutes . Participants are each examined on one occasion only.
Intervention code [1] 286846 0
Not applicable
Comparator / control treatment
No comparator/control group'.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289222 0
This study aims to evaluate the effects of an LLD on foot posture as measured by the Foot posture Index (FPI).
Timepoint [1] 289222 0
At the end of the examination
Secondary outcome [1] 302059 0
None
Timepoint [1] 302059 0
None

Eligibility
Key inclusion criteria
Have an Limb Length Discrepancy (LLD) of five millimetres or greater as diagnosed by the researchers.
Be between 18-65 years old.
Must be ambulatory.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If there is difficulty palpating the participant’s anatomical landmarks (Anterior Superior Iliac Spine (ASIS), and medial malleolus). Inclusion of such patients would lead to an increase in the measurement error for patients with impalpable landmarks, and would lead decreased result validity.
If the patient admits to a past history of lower-limb non-cosmetic surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2013
Actual
15/04/2013
Date of last participant enrolment
Anticipated
31/10/2013
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6651 0
6009 - Crawley

Funding & Sponsors
Funding source category [1] 287000 0
University
Name [1] 287000 0
University of WA
Country [1] 287000 0
Australia
Primary sponsor type
University
Name
University of WA
Address
M422 35 Stirling Highway Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 285784 0
None
Name [1] 285784 0
Address [1] 285784 0
Country [1] 285784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289045 0
Research Ethics and Biosafety Office UWA
Ethics committee address [1] 289045 0
Ethics committee country [1] 289045 0
Australia
Date submitted for ethics approval [1] 289045 0
07/12/2012
Approval date [1] 289045 0
09/01/2013
Ethics approval number [1] 289045 0
RA/4/1/5821

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

Contacts
Principal investigator
Name 38950 0
A/Prof Laurie Foley
Address 38950 0
Faculty member University of WA
M422 35 Stirling Highway CRAWLEY WA 6009
Country 38950 0
Australia
Phone 38950 0
+61 8 6488 4524
Fax 38950 0
+61 8 6488 4525
Email 38950 0
laurie.foley@uwa.edu.au
Contact person for public queries
Name 38951 0
Laurie Foley
Address 38951 0
Faculty member University of WA
M422 35 Stirling Highway CRAWLEY WA 6009
Country 38951 0
Australia
Phone 38951 0
+61 8 6488 4524
Fax 38951 0
+61 8 6488 4525
Email 38951 0
laurie.foley@uwa.edu.au
Contact person for scientific queries
Name 38952 0
Laurie Foley
Address 38952 0
Faculty member University of WA M422 35 Stirling Highway CRAWLEY WA 6009
Country 38952 0
Australia
Phone 38952 0
+61 8 6488 4524
Fax 38952 0
+61 8 6488 4525
Email 38952 0
laurie.foley@uwa.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.