Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000567729
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
20/05/2013
Date last updated
21/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to determine the reliability of the Supination Resistance Arch Blocks test for practitioners with varying levels of clinical experience.
Scientific title
A trial to determine the reliability of the Supination Resistance Arch Blocks test for practitioners with varying levels of clinical experience in healthy volunteers with no symptomatic rearfoot pathology.
Secondary ID [1] 282456 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supination resistance of foot 289068 0
Condition category
Condition code
Other 289410 289410 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Supination Resistance Arch Blocks Test

The participant is told to march on the spot before standing in relaxed calcaneal stance position (RCSP). The tester will perform the Supination Resistance Arch Blocks test as outlined:

1.Place the first ‘block’ attached with an overlying valgus pad underneath the marked navicular tuberosity of each foot.

2. Add additional blocks under the first block until the Neutral Calcaneal Stance Position (NCSP) of the foot is achieved. This is confirmed by using a tractograph to measure the angle between the posterior calcaneal bisection and a line that is perpendicular to the ground.

3. If the NCSP is not achieved, continue adding blocks until the NCSP is achieved.

4. Record the number of blocks required to correct the foot from RCSP to NCSP and the NCSP value of the foot after correction.

The Supination Resistance Arch Blocks test will be performed on both feet of each participant and will take approximately 15 minutes. The test will then be repeated on each foot after a one hour interval by the same tester. Upon completion of the test, the participants will be immediately followed up on their level of satisfaction and any adverse events they may have experienced during the study.
Intervention code [1] 287101 0
Not applicable
Comparator / control treatment
Manual supination resistance test

The manual supination test is used to estimate the amount of force required to supinate the foot about the subtalar joint (STJ). In our study, the manual supination resistance test will be performed after the Supination Resistance Arch Blocks test.

The participant is told to stand in the relaxed calcaneal stance position (RCSP). The tester will then place two fingers under the navicular tuberosity and estimate the amount of upward force required to supinate the STJ from RCSP. At the same time, it must be ensured that the participant is not providing any form of assistance. The amount of upward force required to supinate the STJ will be assigned a supination resistance score between zero to five, with zero being the easiest and five being the hardest.

The manual supination resistance test will be performed on both feet of each participant and will take approximately 5 minutes. The test will be performed for 5 consecutive times on each foot by the same tester and the average score from all five trials will be used for comparison with the Supination Resistance Arch Blocks test.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289519 0
Number of supination resistance arch blocks required to supinate the foot from RCSP to NCSP.

Collected data will be analysed using the SPSS software. To determine the inter-rater and intra-rater reliability of the ‘arch blocks’ test, the Intra-class Correlation Coefficient with a confidence interval of 95% will be used.
Timepoint [1] 289519 0
Upon completion of each round of Supination Resistance Arch Blocks test.
Secondary outcome [1] 302667 0
Relationship between the number of supination resistance arch blocks required to supinate the foot from RCSP to NCSP and the amount of force required to supinate the foot manually.

The Pearson correlation coefficient will be used to determine the relationship between the Supination Resistance Arch Blocks test and manual supination resistance test.
Timepoint [1] 302667 0
Upon completion of data collection.

Eligibility
Key inclusion criteria
1. Age 18 years and above
2. A Body Mass Index (BMI) between 18.5 and 24.9
3. Be available on the allocated testing dates.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A BMI lower than 18.5 or higher than 24.9.
2. Unable to provide informed consent.
3. Have symptomatic rearfoot pathology that will interfere with rearfoot motion.
4. Have an unsteady gait, marked instability or are immobile.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We aim to achieve a sample size of 50 feet (25 participants) in our study. This was estimated based on the sample size used in previous studies which assessed undergraduate populations. As the scope of these studies was similar to ours, we decided to adopt the same approach. In addition, as this is an undergraduate research project with a limited amount of time for data collection, this sample size is most appropriate.

Collected data will be analysed using the SPSS software. To determine the inter-rater and intra-rater reliability of the ‘arch blocks’ test, the Intra-class Correlation Coefficient with a confidence interval of 95% will be used. The correlation between the results obtained from the ‘arch blocks’ test and the manual supination resistance test will be determined by the Pearson correlation coefficient.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287242 0
University
Name [1] 287242 0
Podiatric Medicine Unit, University of Western Australia
Country [1] 287242 0
Australia
Primary sponsor type
University
Name
Podiatric Medicine Unit, University of Western Australia
Address
PODIATRIC MEDICINE UNIT
Park Avenue Building
cnr Park and Crawley Avenues
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 285992 0
None
Name [1] 285992 0
Address [1] 285992 0
Country [1] 285992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289221 0
University of Western Australia Human Research Ethics Office
Ethics committee address [1] 289221 0
Research Services, University of Western Australia
35 Stirling Highway, Crawley WA 6009
Ethics committee country [1] 289221 0
Australia
Date submitted for ethics approval [1] 289221 0
09/11/2012
Approval date [1] 289221 0
26/11/2012
Ethics approval number [1] 289221 0
RA/4/1/5735

Summary
Brief summary
The aim of this study is to develop a new clinical tool to assist in the design of foot orthoses. This tool will be tested on both feet of each study participant by two different investigators and the results obtained will be compared. We will also be comparing the use of this tool to an established clinical test, the manual supination resistance test. At the end of the study, information on participant satisfaction will be collected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39830 0
A/Prof Jennifer Bryant
Address 39830 0
UWA Podiatric Medicine Unit
Room 107 Park Avenue Building
cnr Park and Crawley Avenues
Crawley WA 6009
Country 39830 0
Australia
Phone 39830 0
+61 8 6488 4531
Fax 39830 0
Email 39830 0
[email protected]
Contact person for public queries
Name 39831 0
A/Prof Jennifer Bryant
Address 39831 0
UWA Podiatric Medicine Unit
Room 107 Park Avenue Building
cnr Park and Crawley Avenues
Crawley WA 6009
Country 39831 0
Australia
Phone 39831 0
+61 8 6488 4531
Fax 39831 0
Email 39831 0
[email protected]
Contact person for scientific queries
Name 39832 0
A/Prof Jennifer Bryant
Address 39832 0
UWA Podiatric Medicine Unit
Room 107 Park Avenue Building
cnr Park and Crawley Avenues
Crawley WA 6009
Country 39832 0
Australia
Phone 39832 0
+61 8 6488 4531
Fax 39832 0
Email 39832 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.