Minimalist Shoes Walking for Children

Study Overview
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Brief Summary
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This is a single-blind randomized control study that will investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness. The children in the control group will wear traditional footwear with arch support. It is hypothesized that walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.

Detailed Description
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Intrinsic foot muscles(IFM) are the prime stabilizers of the foot. When the IFM become weakened and unstable, the foot and lower limb become more vulnerable to injury. IFM develop across early childhood and evidence suggests that the critical time window for foot arch development is the first 6 years of life (i.e., preschool age). Human's feet and arches developed naturally due to the daily loads imposed on them, while evidence for using protective footwear to promote arch development is very weak. Moreover, the investigation suggested that local children may have a danger in insufficient daily physical activity. Thus the children may be at high risk for having weak feet. Minimalist shoes are defined as footwear with little to no cushioning, highly flexible soles, and no arch support devices. Minimalist shoes are shaped with a wide toe box, allowing the foot to move more naturally than when confined in conventional footwear. Both running and walking studies have shown that the use of minimalist shoes increases IFM strength by increasing the mechanical load to the foot. Measuring the strength of individual IFM is challenging at best. However, muscle strength has been directly correlated with muscle size. As a result, studies have used imaging techniques such as MRI and ultrasound to measure foot muscle size. A very recent study suggests that walking with minimalist shoes increased the cross-sectional area (CSA), thickness and strength of IFM in adults. Similar findings have been reported by another study adopting a 12-week program. This study aims to investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness. In view of the treatment effectiveness and user-friendliness, walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.

Official Title
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Walking With Minimalist Shoes to Promote Intrinsic Foot Muscle Growth and Foot Arch Integrity in Preschool Children: A Randomized Controlled Trial

Conditions
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Muscle Strength, Ultrasonography, Child, Preschool

Intervention / Treatment
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* Behavioral: in-school walking training with minimalist shoes
* Behavioral: in-school walking training with protective shoes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no history of known neurological or orthopedic conditions presentation of flexible flatfeet with the Chippaux-Smirak Index >0.6 Exclusion Criteria: having previous experience using minimalist footwear presenting with any symptoms in the lower limbs within the last three months

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the single-blinded randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minimalist shoes walking group (MSW)<br>Subjects in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., in-school walking training with minimalist shoes). | Behavioral: in-school walking training with minimalist shoes<br>* Participants in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks. Similar to previous minimalist footwear studies, the intervention duration will be gradually increased over the 12-week training. In brief, subjects will wear the minimalist shoes for 1 out of 5 school days at the first week; 2 days at the second week, and so on until fully use of the minimalist shoes at the fifth week.<br>|
| Active Comparator: traditional shoes walking group (TSW)<br>Subjects in the TSW group will be given a pair of protective shoes with arch support while following the same wearing pattern as the MSW group (i.e., in-school walking training with protective shoes). | Behavioral: in-school walking training with protective shoes<br>* Participants in the TSW group will be given a pair of given a pair of protective shoes with arch support for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks,while follow the same wearing pattern as the MSW group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional area of abductor hallucis in cm^2 | An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of abductor hallucis of the dominant foot. | The assessment will be performed at baseline | 
| Cross-sectional area of abductor hallucis in cm^2 | An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of abductor hallucis of the dominant foot. | The assessment will be performed at 6 weeks | 
| Cross-sectional area of abductor hallucis in cm^2 | An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot. | The assessment will be performed at 12 weeks | 
| Cross-sectional area of flexor digitorum brevis in cm^2 | An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot. | The assessment will be performed at baseline | 
| Cross-sectional area of flexor digitorum brevis in cm^2 | An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot. | The assessment will be performed at 6 weeks | 
| Cross-sectional area of flexor digitorum brevis in cm^2 | An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot. | The assessment will be performed at 12 weeks | 
| Thickness of flexor hallucis brevis in cm | An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot. | The assessment will be performed at baseline | 
| Thickness of flexor hallucis brevis in cm | An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot. | The assessment will be performed at 6 weeks | 
| Thickness of flexor hallucis brevis in cm | An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot. | The assessment will be performed at 12 weeks | 
| IFM strength in Newton | IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice. | The assessment will be performed at baseline | 
| IFM strength in Newton | IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice. | The assessment will be performed at 6 weeks | 
| IFM strength in Newton | IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice. | The assessment will be performed at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot arch stiffness | Walking kinematics and kinetics will be captured for each subject using an eight-camera motion capture system (Vicon, Oxford Metrics Group, Oxford, UK) and a force platform (Kistler Instruments, Winterthur, Switzerland) operating at 200 Hz and 1,000 Hz respectively. Reflective markers will be placed on the first metatarsal head, navicular tuberosity, and medial boarder of the calcaneus of the dominant limb according to a previous study. Following verbal instruction and demonstration, all subjects will be asked to walk barefoot along a 10-meter walkway across the force plate at a self-selected speed. After practicing, five successful walking trials (i.e., within-subject speed < 5% variability) will be obtained from each subject. | The assessment will be performed at baseline, 6 weeks, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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foot muscle strength, foot muscle size, minimal footwear, preschool child, ultrasonography