Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000897662
Ethics application status
Approved
Date submitted
8/08/2014
Date registered
22/08/2014
Date last updated
28/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of Foot Pathologies in Persistent High Heel Wearers versus Non High Heel Wearers
Scientific title
Prevalence of Foot Pathologies in Persistent High Heel Wearers versus Non High Heel Wearers
Secondary ID [1] 285135 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of shoe wear 292709 0
'Foot Pathologies (such as hallux valgus, metatarsalgia, hyperkeratosis, neuroma, digital deformity 292758 0
Condition category
Condition code
Musculoskeletal 293016 293016 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be required to complete an online survey about their current and past shoe wear use and will then be clinically examined to investigate for the presence of foot pathologies.
Intervention code [1] 289987 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292874 0
Comparing different foot complaints of high heeled shoe wearers and non high heeled shoe wearers. Biomechanical assessment via :The Manchester Hallux Valgus grading system is a simple 4-level grading system of the first metatarsophalangeal joint for hallux valgus, first acknowledged by Garrow et al. This 4 Grade (A-D) system proved to be valid with a high inter-rater repeatability and kappa-type 0.86. This Manchester Scale is highly regarded due to its convenience in application, with no specific measurement instrument requirement or radiography: The Ankle Lunge test has been used to assess ankle dorsiflexion in a weight bearing position. The Lunge test proved to have excellent intra rater intra class correlation coefficients (ICC) ranging from 0.97-0.98 with inter rater ICC as high as 0.97 for both distance and angle measurements. :Jack’s Test is a clinical assessment tool of the flatfoot deformity, specifically assessing the break at the naviculo-cuneiform joint which commonly occurs in flat footed individuals. Also referred to as “toe-raising test”, the great toe is maximally dorsiflexed when the patient weight bears on both feet.
EMED Plantar Pressure measurements. The EMED system is an in-floor pressure measurement platform which subjects walk over. :Manchester Foot Pain and Disability Index to identify various types of pain and prevalence of pain in the elderly population. Manchester Foot Pain and Disability index (MFPDI) is a 17-question survey assessing the foot health, functional limitation and pain.
Timepoint [1] 292874 0
Single occasion 21/08/2014
Secondary outcome [1] 309851 0
Nil
Timepoint [1] 309851 0
Nil

Eligibility
Key inclusion criteria
1 Aged 18-45 years old
2 Female
3 Not pregnant
4 Competent in English
5 Subjects who wear any form of footwear for the majority of their week for more than 10 hours a week.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous lower limb surgery (in the last 6 months)
Chronic disease such as diabetes, inflammatory diseases and autoimmune diseases
Professional athletes
Pregnant women

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/08/2014
Actual
21/08/2014
Date of last participant enrolment
Anticipated
Actual
19/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289744 0
Self funded/Unfunded
Name [1] 289744 0
Nil
Country [1] 289744 0
Primary sponsor type
Individual
Name
Laurence Foley
Address
University of Western Australia UWA M422 35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 288435 0
Individual
Name [1] 288435 0
Hea Eun Chung
Address [1] 288435 0
University of Western Australia (UWA) student 3 First Avenue Applecross WA 6153
Country [1] 288435 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293762 0
HUMAN RESEARCH ETHICS APPROVAL - THE UNIVERSITY OF WESTERN AUSTRALIA
Ethics committee address [1] 293762 0
The University of Western Australia
M459, 35 Stirling Highway
Crawley WA 6009 Australia
Ethics committee country [1] 293762 0
Australia
Date submitted for ethics approval [1] 293762 0
04/04/2014
Approval date [1] 293762 0
08/08/2014
Ethics approval number [1] 293762 0
RA/4/1/6746

Summary
Brief summary
This research aims to identify the prevalence of foot pathologies in a female population of persistent high heel footwear users compared to those who do not regularly wear high heel footwear. We seek to identify if there is a correlation between the persistency of high heel footwear use (how many years, how many hours per day) against the severity and number of foot pathologies versus those who use non high heel footwear.


We hypothesize that the prevalence of foot pathologies (such as hallux valgus, metatarsalgia, hyperkeratosis, neuroma, digital deformity) in a female population who are habitual high-heel wearers will be significantly higher compared to non-high heel wearers.
Trial website
Trial related presentations / publications
nil
Public notes
Attachments [1] 155 155 0 0
/AnzctrAttachments/366880-RE_ 4407 HRD high heels research group; request for group meeting after PPD lecture this friday.pdf

Contacts
Principal investigator
Name 50578 0
A/Prof Laurence Foley
Address 50578 0
University of Western Australia (UWA) M422 35 Stirling Hwy, Crawley 6009 WA
Country 50578 0
Australia
Phone 50578 0
+61 08 6488 4524
Fax 50578 0
Email 50578 0
[email protected]
Contact person for public queries
Name 50579 0
Miss Christine Manalip
Address 50579 0
UWA student 810/305 Murray St, Perth WA 6000
Country 50579 0
Australia
Phone 50579 0
+614 25660321
Fax 50579 0
Email 50579 0
[email protected]
Contact person for scientific queries
Name 50580 0
Miss Hea Eun Chung
Address 50580 0
UWA student 3 First Avenue Applecross WA 6153
Country 50580 0
Australia
Phone 50580 0
+614 25213453
Fax 50580 0
Email 50580 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.