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Trial registered on ANZCTR


Registration number
ACTRN12618001096246
Ethics application status
Approved
Date submitted
25/06/2018
Date registered
29/06/2018
Date last updated
12/06/2019
Date data sharing statement initially provided
12/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A long term trial to investigate the effects on strength of the foot and leg, between a mobile shoe and a standard school shoe in children aged nine to twelve.
Scientific title
A prospective randomised controlled trial to investigate the effects on strength of the foot and lower limb between a mobile shoe (with mid-foot flexion availability) and a standard school shoe in children aged nine to twelve.
Secondary ID [1] 295301 0
Nil
Universal Trial Number (UTN)
U1111-1216-1990
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot Strength
 308495 0
Balance 308496 0
Condition category
Condition code
Musculoskeletal 307471 307471 0 0
Normal musculoskeletal and cartilage development and function
Neurological 307472 307472 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobile school shoes, with mid-foot flexion availability
a. Participants will be either in the control group, where they will be issued with current standard school shoes (eg Daytona Clarks); or in the experimental group where they will be given a new type of shoe (currently on sale for adults in the UK), which is very light and mobile through the shoe.
b. all the children will be provided with their correct size shoe.
c. Participants will be tracked with their volume of hours wear per week, but are encouraged to wear the experiment shoes as often as possible. However, both groups will be wearing them for normal school hours.
d. The trial will run for ten months, and the participants are to wear their assigned shoes to school for that period of time. This is to allow enough time for adaptation, but not have a large period of vacation before re-testing, where many wear different shoes.
e. We will be using REDCap, an online survey system, to send out a weekly email for the parents to complete. It will involve ticking a box out of 3 options: less than 20 hours per week, 20-30hrs per week, >30hrs per week. They will be their only school shoes and the school is strict about the dress code.
Intervention code [1] 301637 0
Lifestyle
Comparator / control treatment
The control group will wear standard, stiff school shoes
Control group
Active

Outcomes
Primary outcome [1] 306444 0
Ultrasound cross-sectional area of abductor hallucis
Timepoint [1] 306444 0
Initial and 10 months post shoe use commencement.
Primary outcome [2] 306507 0
Ultrasound cross-sectional area of flexor digitorum brevis
Timepoint [2] 306507 0
Initial and ten months post shoe use commencement
Secondary outcome [1] 348563 0
Static balance
This will be tested with the single leg balance test, eyes open, then eyes closed. Three sets of each will be performed. This will be performed on the dominant leg (leg they kick a ball with).
Child instructed to stand gaze at point ahead of them and when ready, lift non-dominant foot off the floor, without bracing it to the other leg. As the foot lifts, a timer will be started and stopped either when they reach 30 secs, or when: the foot touches down, is used to balance by moving around, the foot on the floor moves out of original position. They eyes closed test is the same, but the timer will be stopped also when the eyes are opened to balance.
Timepoint [1] 348563 0
Initial and ten months post shoe use commencement
Secondary outcome [2] 348564 0
Active balance
Adapted star excursion balance test, or SEBT. Y-Balance Test (the modified SEBT) is a test of balance on one leg, whilst the other is reaching in three different directions consecutively, without placing the lifted foot on the floor until complete. The Y shape is marked out on a smooth surface, with tape. The center of the Y is the standing position, with the single strip in front of the child and the two arms of the Y in the posterolateral and posteromedial equidistant from each other (at 45° from the continuum of the anterior line in the posterior direction). The weight-bearing foot is aligned so that the toes are along the tape facing the anterior direction, and the posterior aspect of heel of the foot is facing the posterior direction. The child is allowed 4 practice attempts with a 30 second break, before trials 5 to 7 are recorded.
Timepoint [2] 348564 0
Initial and ten months post shoe use commencement
Secondary outcome [3] 348565 0
Forward jump distance
The participant stands with feet side by side and is instructed to leap with both legs, at the same time, as far forward as they are able, without falling over. They are allowed 2 practice trials, before the 3rd distance is recorded.
Timepoint [3] 348565 0
Initial and ten months post shoe use commencement
Secondary outcome [4] 348708 0
Toe flexor strength
Assessed with participant sitting in a chair with foot resting on a small bench (knees and ankles at 90 degrees), with toes over the front of the bench. The examiner will gently secure the ankle so that the foot does not lift during testing.
A hand-held dynamometer (HHD)(make to be confirmed - most likely CITEC) placed under the neutral Hallux only. The strongest of 3 plantar-flexion measures will be recorded for analysis. this will be repeated under the 4 lesser toes. HHD has been shown to have high reliability and validity on smaller joint testing.
Timepoint [4] 348708 0
Initial intake and ten months post shoe use commencement

Eligibility
Key inclusion criteria
healthy participants aged 9-12yrs
Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include: 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed in opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization. Repeated twice to ensure full randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
One-way ANOVA
A power analysis was used to determine the participant numbers. This was based on work by Chen et al 2016, which was the closest we could find to our study, because they had 2 groups of runners (20 and 18 in the groups) running only (3-4 times per week) in normal vs minimalist shoes. Chen et al then analysed the muscle morphology with MRI of the same muscles that we will be examining. There findings were clinically significant differences.
We found an effect size of 0.85 with 30 participants. We wanted to accommodate for any drop outs.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
1/09/2018
Actual
28/09/2018
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
34
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299894 0
University
Name [1] 299894 0
The University of Sydney
Country [1] 299894 0
Australia
Funding source category [2] 299948 0
Commercial sector/Industry
Name [2] 299948 0
C. & J. Clark International Limited
Country [2] 299948 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
75 East Street | Lidcombe | NSW | 2141
Country
Australia
Secondary sponsor category [1] 299264 0
None
Name [1] 299264 0
Address [1] 299264 0
Country [1] 299264 0
Other collaborator category [1] 280197 0
Commercial sector/Industry
Name [1] 280197 0
C. & J. Clark International Limited
Address [1] 280197 0
40 High Street, Street, Somerset BA16 0EQ, United Kingdom.
Country [1] 280197 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300763 0
The University of Sydney Human Research Ethics Committee HREC2
Ethics committee address [1] 300763 0
Ethics committee country [1] 300763 0
Australia
Date submitted for ethics approval [1] 300763 0
06/04/2017
Approval date [1] 300763 0
07/08/2017
Ethics approval number [1] 300763 0
2017/309

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

Contacts
Principal investigator
Name 84734 0
Dr Shayan Quinlan
Address 84734 0
c/o Assoc Prof Peter Sinclair
Head of Discipline of Exercise and Sport Science
Faculty of Health Sciences
THE UNIVERSITY OF SYDNEY
Room K215
75 East Street | Lidcombe | NSW | 2141
Country 84734 0
Australia
Phone 84734 0
+61 (0)414807302
Fax 84734 0
Email 84734 0
squi6126@uni.sydney.edu.au
Contact person for public queries
Name 84735 0
Peter Sinclair
Address 84735 0
Head of Discipline of Exercise and Sport Science
Faculty of Health Sciences
THE UNIVERSITY OF SYDNEY
Room K215
75 East Street | Lidcombe | NSW | 2141
Country 84735 0
Australia
Phone 84735 0
+61 2 9351 9724
Fax 84735 0
Email 84735 0
peter.sinclair@sydney.edu.au
Contact person for scientific queries
Name 84736 0
Peter Sinclair
Address 84736 0
Head of Discipline of Exercise and Sport Science
Faculty of Health Sciences
THE UNIVERSITY OF SYDNEY
Room K215
75 East Street | Lidcombe | NSW | 2141
Country 84736 0
Australia
Phone 84736 0
+61 2 9351 9724
Fax 84736 0
Email 84736 0
peter.sinclair@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication. No end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approval by principal investigator.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExcellent reliability of toe strength measurements in children aged ten to twelve years achieved with a novel fixed dynamometer.2021https://dx.doi.org/10.1016/j.gaitpost.2021.01.015
N.B. These documents automatically identified may not have been verified by the study sponsor.