Clinical trial NCT03853863: Minimalist Shoes Walking for Children
Official title: Walking With Minimalist Shoes to Promote Intrinsic Foot Muscle Growth and Foot Arch Integrity in Preschool Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Strength
Ultrasonography
Child, Preschool
Keywords: foot muscle strength
foot muscle size
minimal footwear
preschool child
ultrasonography
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: Harvard Medical School (HMS and HSDM)
First posted: 2019-02-26
Enrollment: 116
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the single-blinded randomized control trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cross-sectional area of abductor hallucis in cm^2
timeFrame: The assessment will be performed at baseline
measure: Cross-sectional area of abductor hallucis in cm^2
timeFrame: The assessment will be performed at 6 weeks
measure: Cross-sectional area of abductor hallucis in cm^2
timeFrame: The assessment will be performed at 12 weeks
measure: Cross-sectional area of flexor digitorum brevis in cm^2
timeFrame: The assessment will be performed at baseline
measure: Cross-sectional area of flexor digitorum brevis in cm^2
timeFrame: The assessment will be performed at 6 weeks
measure: Cross-sectional area of flexor digitorum brevis in cm^2
timeFrame: The assessment will be performed at 12 weeks
measure: Thickness of flexor hallucis brevis in cm
timeFrame: The assessment will be performed at baseline
measure: Thickness of flexor hallucis brevis in cm
timeFrame: The assessment will be performed at 6 weeks
measure: Thickness of flexor hallucis brevis in cm
timeFrame: The assessment will be performed at 12 weeks
measure: IFM strength in Newton
timeFrame: The assessment will be performed at baseline
measure: IFM strength in Newton
timeFrame: The assessment will be performed at 6 weeks
measure: IFM strength in Newton
timeFrame: The assessment will be performed at 12 weeks
Secondary outcomes:
measure: Foot arch stiffness
timeFrame: The assessment will be performed at baseline, 6 weeks, and 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Roy TH Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10.
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.
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.
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.
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.