Anthropometric and Biomechanical Analysis of the Infant Foot
ABIP
1 other identifier
interventional
1,216
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
July 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2023
CompletedJune 6, 2023
June 1, 2023
9 months
May 15, 2022
June 4, 2023
Conditions
Keywords
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:
EXPERIMENTALAn 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.
Interventions
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.
Eligibility Criteria
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
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.
PMID: 18417345RESULTBeulertz 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.
PMID: 25881810RESULTBok 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.
PMID: 27458719RESULTBuckland 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.
PMID: 25251796RESULTGonzalez 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.
PMID: 31077163RESULTDominguez 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.
PMID: 40746028DERIVED
Study Officials
- STUDY CHAIR
Aníbal Báez Suárez, PhD
University of Las Palmas de Gran Canaria
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