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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001096246

Enrollment

Registered

2018-06-29

Start date

2018-08-01

Completion date

2018-09-28

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesise that a minimal, mobile shoe design will increase foot and lower limb muscle strength and performance outcomes in children compared to standard school shoes, over time. To test this, we are measuring the change in children after ten months of wearing two very different shoes to school; one group in the common school shoe and the other in a very mobile shoe. We hope that this will scientifically inform future shoe design, which is currently not well understood for children.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

9 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

healthy participants aged 9-12yrs

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.

Outcome results