NCT03853863

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 11, 2020

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

February 20, 2019

Last Update Submit

February 10, 2020

Conditions

Muscle StrengthUltrasonographyChild, Preschool

Keywords

foot muscle strengthfoot muscle sizeminimal footwearpreschool childultrasonography

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (1)

  • Foot arch stiffness

    The assessment will be performed at baseline, 6 weeks, and 12 weeks

Study Arms (2)

minimalist shoes walking group (MSW)

EXPERIMENTAL

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

traditional shoes walking group (TSW)

ACTIVE COMPARATOR

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

Interventions

in-school walking training with minimalist shoesBEHAVIORAL

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.

minimalist shoes walking group (MSW)
in-school walking training with protective shoesBEHAVIORAL

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.

traditional shoes walking group (TSW)

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • no history of known neurological or orthopedic conditions
  • presentation of flexible flatfeet with the Chippaux-Smirak Index \>0.6

You may not qualify if:

  • having previous experience using minimalist footwear
  • presenting with any symptoms in the lower limbs within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

Location

Related 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). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10.

    PMID: 27195735BACKGROUND

  • 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.

    PMID: 26509371BACKGROUND

  • 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.

    PMID: 30113521BACKGROUND

  • 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.

    PMID: 29234467BACKGROUND

  • 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.

    PMID: 28808276BACKGROUND

Study Officials

  • Roy TH Cheung, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Assessment will be conducted by independent researchers who are not involved in subject allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the single-blinded randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 26, 2019

Study Start

December 1, 2020

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

February 11, 2020

Record last verified: 2019-08

Locations

CN(1)