Minimalist Shoes Walking for Children

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03853863
• Other study ID #: HMRF_RC
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Preschool
• Muscle Strength
• Ultrasonography

Intervention

Behavioral:
• in-school walking training with minimalist shoes
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.
• in-school walking training with protective shoes
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.

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Chinese University of Hong Kong, Harvard Medical School

Country where clinical trial is conducted

China, 

References & Publications (5)

Chen TL, Sze LK, Davis IS, Cheung RT. Effects of training in minimalist shoes on the intrinsic and extrinsic foot muscle volume. Clin Biomech (Bristol, Avon). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10. — View Citation

Hollander K, de Villiers JE, Sehner S, Wegscheider K, Braumann KM, Venter R, Zech A. Growing-up (habitually) barefoot influences the development of foot and arch morphology in children and adolescents. Sci Rep. 2017 Aug 14;7(1):8079. doi: 10.1038/s41598-017-07868-4. — View Citation

Johnson AW, Myrer JW, Mitchell UH, Hunter I, Ridge ST. The Effects of a Transition to Minimalist Shoe Running on Intrinsic Foot Muscle Size. Int J Sports Med. 2016 Feb;37(2):154-8. doi: 10.1055/s-0035-1559685. Epub 2015 Oct 28. — View Citation

Ridge ST, Myrer JW, Olsen MT, Jurgensmeier K, Johnson AW. Reliability of doming and toe flexion testing to quantify foot muscle strength. J Foot Ankle Res. 2017 Dec 8;10:55. doi: 10.1186/s13047-017-0237-y. eCollection 2017. — View Citation

Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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