Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000609752
Ethics application status
Approved
Date submitted
10/05/2013
Date registered
28/05/2013
Date last updated
28/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Repeated Measures Reliability Study that Assesses the Consistency of the Paediatric Flatfoot Proforma in identifying the foot type of students between the ages of 7-12.
Scientific title
A Repeated Measures Reliability Study that Assesses the Consistency of the Paediatric Flatfoot Proforma in identifying the foot type of students between the ages 7 - 12
Secondary ID [1] 282486 0
Nil
Universal Trial Number (UTN)
U1111-1142-9640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Flatfoot
 289119 0
Condition category
Condition code
Musculoskeletal 289456 289456 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
Students will be observed for presence of Paediatric flatfoot with use of the Foot Posture Index. The foot posture index is a measurement tool that uses 6 criteria (Talar Head palpation, Curves above and below the lateral malleoli, Inversion/Eversion of the Calcaneus, Bulge in the region of the TNJ, Congruence of the medial longitudinal arch, abd/adduction of the forefoot on rearfoot).

The type of flatfoot (Typical Flexible flatfoot, Rigid Flatfoot, and Skewfoot)will then be determined using the Paediatric Flatfoot Proforma. The Proforma involves observations such as Medial arch height, Heel eversion, Heel Inversion with tip toe, Tibial and knee positions, Navicular Height, Resting Calcaneal Stance Position, Muscle tone, Ligament laxity as well as History taking.

The Proforma will performed twice on each participant by four different raters. The second measurement will take place 2 weeks after the first measurement. The total time taken to perform the proforma on 1 participant by 1 rater will be approximately 5 minutes.
Intervention code [1] 287136 0
Early detection / Screening
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289558 0
Inter-rater Reliability of the Paediatric Flatfoot Proforma. This is assessed by the use of 3 different raters. After all measurements are obtained, data will be entered and analysed using constructed data sets in SPSS Version 20 and microsoft excel 2010 software packages. Inter-rater Reliability will be calculated using 95% confidence intervals.
Timepoint [1] 289558 0
Immediately after all children have had their foot structure measured
Primary outcome [2] 289559 0
Intra Rate Reliability of the Paediatric Flatfoot Proforma in Podiatric Practice. This is assessed by the use of 3 different raters. After all measurements are obtained, data will be entered and analysed using constructed data sets in SPSS Version 20 and microsoft excel 2010 software packages. Intra-rater Reliability will be calculated using 95% confidence intervals
Timepoint [2] 289559 0
Immediately after all children have had their foot structure measured
Primary outcome [3] 289560 0
Intraclass coefficients will be calculated using 95% confidence intervals.
Calculating ICC’s allows for comparison to previous studies.
Timepoint [3] 289560 0
Immediately after all children have had their foot structure measured
Secondary outcome [1] 302743 0
Foot Types in the Paediatric Population. Data will be entered into SPSS and analysed.
Timepoint [1] 302743 0
Immediately after all children have had their foot structure measured

Eligibility
Key inclusion criteria
-Primary School children aged between 7-12
-Foot Posture index score of greater than or equal to 6 bilaterally
-Informed Consent from parents or guardians
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Children over the age of twelve, and under the age of seven.
- Congenital disorders that have a direct effect on the foot
(eg. Talipes calcaneovalgus).
- Previous surgery on the foot.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be entered and all analyses performed using constructed data sets in SPSS version 20 and Microsoft Excel 2010 software packages. Inter-rater, intra-rater and intraclass coefficients (ICC) will be calculated using 95% confidence intervals. Calculating ICC’s allows for comparison to previous studies.

For Samples size a power calculation concluded that eleven participants per examiner (3 Examiners) would be statistically significant. The power calculation was calculated using a probability of type 1 error of 0.05 and aiming for the study to have a power of 0.8. A correlation coefficient of 0.7 is the figure Evans claimed to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6878 0
6014 - Wembley

Funding & Sponsors
Funding source category [1] 287267 0
University
Name [1] 287267 0
University of Western Australia
Country [1] 287267 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Cnr Park and Crawley Avenues, Crawley WA 2009
Country
Australia
Secondary sponsor category [1] 286020 0
Individual
Name [1] 286020 0
Associate Professor Jennifer Bryant
Address [1] 286020 0
Cnr Park and Crawley Avenues, Crawley WA 2009. University of Western Australia
Country [1] 286020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289247 0
Human research Ethics comittee of the University of Western Australia (HREC)
Ethics committee address [1] 289247 0
Ethics committee country [1] 289247 0
Australia
Date submitted for ethics approval [1] 289247 0
Approval date [1] 289247 0
11/04/2013
Ethics approval number [1] 289247 0
RA/4/1/5738

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

Contacts
Principal investigator
Name 39966 0
A/Prof Jennifer Bryant
Address 39966 0
Offices in Cnr Park and Crawley Avenues, Crawley WA 2009. University Of Western Australia
Country 39966 0
Australia
Phone 39966 0
+61 8 6488 4531
Fax 39966 0
Email 39966 0
[email protected]
Contact person for public queries
Name 39967 0
Jennifer Bryant
Address 39967 0
Offices in Cnr Park and Crawley Avenues, Crawley WA 6009. University of Western Australia
Country 39967 0
Australia
Phone 39967 0
+61 8 6488 4531
Fax 39967 0
Email 39967 0
[email protected]
Contact person for scientific queries
Name 39968 0
Jennifer Bryant
Address 39968 0
Offices in Cnr Park and Crawley Avenues, Crawley WA 6009. University of Western Australia
Country 39968 0
Australia
Phone 39968 0
+61 8 6488 4531
Fax 39968 0
Email 39968 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.