Clinical trial NCT05386992: Anthropometric and Biomechanical Analysis of the Infant Foot
Official title: Anthropometric and Biomechanical Analysis of the Children's Foot for the Design of Healthy Footwear: ABIP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Keywords: Children
Foot development
Foot posture
Paediatric foot
Shoes
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 1216
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Given that the data we have so far comes from studies that are not very current and on small samples, there is a need to update these variables to transfer these results to the productive fabric.

Therefore, the objective of this research is to carry out an anthropometric and biomechanical analysis of the infant foot in order to use these data in the creation of a standard last that respects its morphology.

Subsequently, said last will be subjected to different fit tests to verify its correct adaptation to the foot in this population group.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Shoe test
timeFrame: Up to 3 month
measure: Plantar pressure
timeFrame: Up to 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Manuel Pereira Domínguez.
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez Suárez, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.