Child, OnlyABIPNCT05386992
Anthropometric and Biomechanical Analysis of the Infant Foot
A study testing Anthropometric study in people with Child, Only, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only
- What is being tested?
- Anthropometric study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,216 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jul 2022to 4 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anthropometric and Biomechanical Analysis of the Children's Foot for the Design of Healthy Footwear: ABIP Study
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.
Read the 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.
- Conditions
- Child, Only
- Being tested
- Anthropometric study
- Keywords
- Children, Foot development, Foot posture, Paediatric foot, Shoes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric studyDiagnostic test
Also called Design and manufacture of shoes and fit tests
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Anthropometric study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start30 Jul 2022
- Primary completion10 May 2023
- Study completion4 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Aníbal Báez Suárez, PhD, Study chair, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386992
- Sponsor's protocol ID
- ABIP
- Acronym
- ABIP
- Status last verified
- Jun 2023
- First submitted
- 15 May 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18417345Beulertz 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.
PubMed 25881810Bok 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.
PubMed 27458719Buckland 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.
PubMed 25251796Gonzalez 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.
PubMed 31077163Dominguez 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.
PubMed 40746028
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric and Biomechanical Analysis of the Children's Foot for the Design of Healthy Footwear: ABIP Study
- ClinicalTrials.gov ID
- NCT05386992
- Acronym / sponsor ID
- ABIP / ABIP
- Conditions
- Child, Only
- Keywords
- Children, Foot development, Foot posture, Paediatric foot, Shoes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 4 Jun 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anthropometric study of children's feet and healthy standard last design: | Experimental | Diagnostic Test: Anthropometric studyAn 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. |
Who may qualify
- Ages
- 12 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometric studyAlso: Design and manufacture of shoes and fit testsOnce 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. | Diagnostic test | Anthropometric study of children's feet and healthy standard last design: |
Primary outcome
Shoe test
Time frame: Up to 3 month
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.
Plantar pressure
Time frame: Up to 3 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Results publication: PubMed 18417345Alvarez 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.
- Results publication: PubMed 25881810Beulertz 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.
- Results publication: PubMed 27458719Bok 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.
- Results publication: PubMed 25251796Buckland 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.
- Results publication: PubMed 31077163Gonzalez 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.
- Derived from this study: PubMed 40746028Dominguez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aníbal Báez Suárez, PhD study chair
University of Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthropometric study in people with Child, Only, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoe test (time frame: Up to 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386992, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.