NCT05386992

Brief Summary

In the era of science and technology, footwear has become not only an essential item of clothing, but also another tool for the optimal development of children, the improvement of work and sports performance or the prevention and treatment of pathologies. The anthropometric characteristics of the child's foot differ considerably from those of the adult foot, in fact, it is not until the age of 18-19 years that the structure of the foot is finally consolidated. Therefore, it is essential that footwear manufacturers know these characteristics to achieve an adequate design. Current scientific evidence highlights the importance of considering the unique morphology of the infant foot, as well as the high functional demands to which footwear is subjected at these ages. There is a lack of studies that analyze in detail the shape of the child's foot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

May 15, 2022

Last Update Submit

June 4, 2023

Conditions

Keywords

ChildrenFoot developmentFoot posturePaediatric footShoes

Outcome Measures

Primary Outcomes (2)

  • Shoe test

    Using different reference points of the foot, the areas to be measured will be measured in millimeters. They are collected by digitizing the foot and ankle of each person, using the 3D scanner and the IcadPie Software.

    Up to 3 month

  • Plantar pressure

    Based on sensory technology, the sensors are placed along a fixed platform, connected via a universal serial bus cable to a computer and appropriate software. The sensors, by supporting pressure, generate a potential difference that can be measured. This electrical voltage value is detected by the sensors themselves, and a computer program reinterprets it in the form of a graph with the captured values. The graph consists of a plantar footprint with a range of colors, according to the relative baropressure captured. This instrument would provide us with quantifiable data about how load patterns behave in bare feet and shoes, in order to establish useful comparisons in our study

    Up to 3 month

Study Arms (1)

Anthropometric study of children's feet and healthy standard last design:

EXPERIMENTAL

An anthropometric study of the feet of the subjects included in the sample will be carried out. The variables of interest used in this work are collected by digitizing the foot and ankle of each person, as well as through an anonymous questionnaire, which the study volunteers and their parents or legal guardians fill out and deliver. From the data collected, 5 models of healthy standard last will be produced that are adapted to the anthropometric characteristics of our study population: sports last, boot last, sandal last, ballerina last and moccasin last.

Diagnostic Test: Anthropometric study

Interventions

Anthropometric studyDIAGNOSTIC_TEST

Once the 5 models of lasts have been produced in phase 1, certain shoe models will be designed and manufactured based on these lasts at random and at the free choice of the designers of a footwear company. These models will then be physically tested on children to analyze their effects on walking and walking.

Also known as: Design and manufacture of shoes and fit tests
Anthropometric study of children's feet and healthy standard last design:

Eligibility Criteria

Age12 Months - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • School-age boys and girls with foot sizes between 20 and 41
  • Attending school and belonging to public, private or concerted schools, to guarantee the variability of the sample in terms of type of school.

You may not qualify if:

  • Present a severe structural or functional alteration of the foot, which prevents an adequate digitization of the foot and ankle with the hardware and software used to collect the samples.
  • Not having the signature of the informed consent or express authorization of the parents or legal guardians to carry out the measurement and the subsequent processing of the data.
  • Inability to stand or walk independently.
  • Present crying or fear, not being cooperative or engaging in inappropriate behavior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuel Pereira Domínguez.

Seville, 41003, Spain

Location

Related Publications (6)

  • Alvarez C, De Vera M, Chhina H, Black A. Normative data for the dynamic pedobarographic profiles of children. Gait Posture. 2008 Aug;28(2):309-15. doi: 10.1016/j.gaitpost.2008.01.017. Epub 2008 Apr 15.

  • Beulertz J, Bloch W, Prokop A, Rustler V, Fitzen C, Herich L, Streckmann F, Baumann FT. Limitations in Ankle Dorsiflexion Range of Motion, Gait, and Walking Efficiency in Childhood Cancer Survivors. Cancer Nurs. 2016 Mar-Apr;39(2):117-24. doi: 10.1097/NCC.0000000000000256.

  • Bok SK, Lee H, Kim BO, Ahn S, Song Y, Park I. The Effect of Different Foot Orthosis Inverted Angles on Plantar Pressure in Children with Flexible Flatfeet. PLoS One. 2016 Jul 26;11(7):e0159831. doi: 10.1371/journal.pone.0159831. eCollection 2016.

  • Buckland MA, Slevin CM, Hafer JF, Choate C, Kraszewski AP; Hospital for Special Surgery Pediatric Research Team. The effect of torsional shoe flexibility on gait and stability in children learning to walk. Pediatr Phys Ther. 2014 Winter;26(4):411-7. doi: 10.1097/PEP.0000000000000084.

  • Gonzalez Elena ML, Cordoba-Fernandez A. Footwear fit in schoolchildren of southern Spain: a population study. BMC Musculoskelet Disord. 2019 May 10;20(1):208. doi: 10.1186/s12891-019-2591-3.

  • Dominguez MP, Blanco SG, Paralera-Morales C, Martinez AR, Quintana-Montesdeoca MP, Baez-Suarez A. Anthropometric Foot Variations in Children: A Cross-Sectional Study Supporting Sex-Based Last Design. J Foot Ankle Res. 2025 Sep;18(3):e70069. doi: 10.1002/jfa2.70069.

Study Officials

  • Aníbal Báez Suárez, PhD

    University of Las Palmas de Gran Canaria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 24, 2022

Study Start

July 30, 2022

Primary Completion

May 10, 2023

Study Completion

June 4, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations