NCT07451509

Brief Summary

This study aims to evaluate the validity and reliability of a proposed plantar pressure assessment intrument based on an implementation of machine learning into optical pedography.

Trial Health

63
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Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress25%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 11, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 11, 2026

Last Update Submit

February 28, 2026

Conditions

Keywords

pedographymachine learningAIplantar pressurevalidityreliability

Outcome Measures

Primary Outcomes (4)

  • Criterion validity of foot area measurement

    The total contact area of the foot during a static stance will be measured by the machine learning based optical pedography Instrument and compared to the gold standard pedobarographic platform. The validity will be determined by the Pearson Correlation Coefficient (r) between the two devices. Unit of measure: Pearson Correlation Coefficient (r) ranging from -1 to 1.

    Day 1

  • Criterion validity of peak plantar pressure distribution

    The distribution of pressure across the plantar surface (specifically mean peak pressure) will be measured. Validity will be assessed by calculating the Intraclass Correlation Coefficient (ICC) between the machine learning based optical pedography instrument and the gold standard pedobarographic platform. Unit of measure: Intraclass Correlation Coefficient (ICC) ranging from 0 to 1.

    Day 1

  • Intrasession reliability of foot area measurement

    The consistency of the total contact area (cm 2) measured across 5 repeated trials within a single session. Reliability will be assessed using the Intraclass Correlation Coefficient (ICC 3,5) to determine the degree of agreement between the five captures of the same participant's feet. Units of measure: Intraclass Correlation Coefficient (ICC) ranging from 0 to 1

    Day 1

  • Intrasession reliability of mean peak pressure

    The consistency of mean peak pressure measurements across 5 repeated trials within a single session. Reliability will be assessed by calculating the Intraclass Correlation Coefficient (ICC 3,5) for the five measurements taken on the machine learning based optical pedography instrument. Unit of measure: Intraclass Correlation Coefficient (ICC) ranging from 0 to 1

    Day 1

Interventions

Optical pedographyDIAGNOSTIC_TEST

Comparison of 5 alternating measures taken on podoscope and pedobarographic platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals willing to participate in the study protocol

You may qualify if:

  • A healthy individual with no absence of lower extremity
  • Aged ≥18 years
  • Willingness to participate and ability to follow the assessors instructions.

You may not qualify if:

  • Presence of foot diseases alternating foot contact area
  • Cognitive or psychiatric disorders limiting cooperation
  • Lack of informed consent or non-compliance during imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Palacký University Olomouc, Czech Republic

Olomouc, Czechia, 77900, Czechia

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 11, 2026

First Posted

March 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient privacy and institutional data protection policies

Locations