Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001162707
Ethics application status
Approved
Date submitted
2/08/2022
Date registered
24/08/2022
Date last updated
24/08/2022
Date data sharing statement initially provided
24/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Walking with minimalist shoes to promote intrinsic foot muscle growth and balance in primary school children: A preliminary study
Scientific title
Walking with minimalist shoes to promote intrinsic foot muscle growth, foot arch integrity, and balance in primary school children: A preliminary study
Secondary ID [1] 304851 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot biomechanics 327299 0
Condition category
Condition code
Musculoskeletal 320514 320514 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Minimalist shoes to be worn at school by the participants aged 9-12 years. Provided by Softstar - RunAmoc shoes

The participants were all fitted with standard sample sizes of the minimalist shoe during screening, which were provided by the manufacturer (Softstar) for this purpose. This ensured that the correct shoe size was ordered for each child.

The shoes were then ordered and produced in the USA based on their standard sizing. Participants wear the shoes as per school policy, 8 hours per day for 3 normal school days and their own sports shoes on the 2 assigned "sports" days at school. The participants will be wearing the shoes for three full terms at school, from April to December.

Parents complete a weekly brief survey to provide a guided estimate of shoe use per week.
Intervention code [1] 321234 0
Prevention
Comparator / control treatment
Historical control group. The group in this trial will be compared to our previous study where the children wore standard school shoes in the control group and flexible shoes in the experimental group (ACTRN12618001096246). The study will be run in the same format as our previous study to allow for this comparison.

Both the control and intervention group data from ACTRN12618001096246 will be used to compare this data against. This historical data was collected from 14 January 2019 to 18 September 2019.
Control group
Historical

Outcomes
Primary outcome [1] 328345 0
Cross-sectional area using ultrasound of the intrinsic foot muscles
Timepoint [1] 328345 0
Measures are taken pre-and post intervention, 8 months later
Primary outcome [2] 328346 0
Foot muscle strength
This is measured using a secured dynamometer as described in our publication: Quinlan, S., Sinclair, P., Hunt, A., Fong Yan, A., Excellent reliability of toe strength measurements in children aged ten to twelve years achieved with a novel fixed dynamometer. Gait & Posture, 2021. 85: p. 20-24.
Timepoint [2] 328346 0
Measures are taken pre-and post intervention, 8 months later
Secondary outcome [1] 398670 0
Balance:
Y-balance test : The test is performed whilst standing on the dominant foot and the contralateral foot reaching anteriorly, posteromedially and postero-laterally as far as the participant was able along measuring tape set on the floor, without touching the floor with the elevated foot or shifting the standing foot from its starting position. Five practice attempts were conducted before recording three consecutive trials.
Timepoint [1] 398670 0
Measures are taken pre-and post intervention, 8 months later
Secondary outcome [2] 398671 0
Standing long jump: The participant stands in a relaxed position, with the feet at shoulder width apart and toes behind the zero on a measuring tape of 2.5 m length which was secured to the floor in a straight line. The participant then jumped forwards as far as possible using both legs simultaneously, with arm swing and landing without losing balance or moving the feet. The participant is allowed up to two submaximal trials prior to a thirty second wait before the recorded trials. The measurement in centimetres from the
most posterior heel position was recorded and repeated three times
Timepoint [2] 398671 0
Measures are taken pre-and post intervention, 8 months later

Eligibility
Key inclusion criteria
Healthy children between the ages of 9-12 years
Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
hypermobility, disability affecting testing, recent foot or limb injury, wearers of orthotics, obesity (due to the influence on the arch of the foot), gymnasts or dancers doing more than 4 hours per week (due to foot strength), or score above 7 on the Beighton and Horan Joint Mobility Index for ligament laxity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
historical comparison with both control and intervention groups from ACTRN12618001096246
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size analysis was conducted using G*Power (Version 3.1.3, University of Kiel, Germany). Based on our previous study (Chen et al. 2016), the increase of intrinsic foot muscle (IFM) size after 8-week minimalist shoes walking program yielded Cohen’s d of 0.54-0.62. Using the smallest effect size reported, an alpha of 0.05, power of 0.90, attrition rate of 15%, a sample size of 35 individuals will be sufficient to power this study.

The participants age, body mass index (BMI) and balance (static) will be compared at baseline using one-way ANOVA to ensure the groups were appropriately matched on factors that could influence the outcome of the intervention.

In brief, we will compare the demographics and subject characteristics between the two groups using independent t tests and chi-square tests. If the dataset fulfills the assumptions of parametric analyses, we will use an one-way between-groups analysis of covariance (ANCOVA) to test differences in the dependent variables (i.e., intrinsic foot muscle size, foot strength, and balance) between the two groups (i.e., minimalist and traditional shoe groups in ACTRN12618001096246) with the consideration of activity level as a covariate.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2022
Date of last participant enrolment
Anticipated
Actual
9/03/2022
Date of last data collection
Anticipated
9/12/2022
Actual
Sample size
Target
35
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34770 0
2100 - Oxford Falls

Funding & Sponsors
Funding source category [1] 309225 0
University
Name [1] 309225 0
Western Sydney University
Country [1] 309225 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Softstar
Address
914 Main Street
Philomath, OR 97370 USA
Country
United States of America
Secondary sponsor category [1] 310188 0
None
Name [1] 310188 0
Address [1] 310188 0
Country [1] 310188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309073 0
University of Sydney Ethics committee
Ethics committee address [1] 309073 0
Ethics committee country [1] 309073 0
Australia
Date submitted for ethics approval [1] 309073 0
25/03/2021
Approval date [1] 309073 0
06/10/2021
Ethics approval number [1] 309073 0
2021/348

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

Contacts
Principal investigator
Name 112878 0
Prof Roy Cheung
Address 112878 0
Western Sydney University
Locked Bag 1797
Penrith, NSW 2751
Australia
Country 112878 0
Australia
Phone 112878 0
+61 432165010
Fax 112878 0
Email 112878 0
[email protected]
Contact person for public queries
Name 112879 0
Roy Cheung
Address 112879 0
Western Sydney University
Locked Bag 1797
Penrith, NSW 2751
Australia
Country 112879 0
Australia
Phone 112879 0
+61 432165010
Fax 112879 0
Email 112879 0
[email protected]
Contact person for scientific queries
Name 112880 0
Roy Cheung
Address 112880 0
Western Sydney University
Locked Bag 1797
Penrith, NSW 2751
Australia
Country 112880 0
Australia
Phone 112880 0
+61 432165010
Fax 112880 0
Email 112880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16787Study protocolThe PhD thesis by the author, Shayan Quinlan has the full study protocol and is titled: The long-term effects of shoe flexibility on a child’s foot development and gross motor skill performance This can be accessed at the University of Sydney Library at: https://hdl.handle.net/2123/27614 https://hdl.handle.net/2123/27614[email protected]



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.