Implementation of Machine Learning Into Optical Pedography

February 28, 2026 updated by: Jonatan Dvoracek, Palacky University

Implementing Machine Learning Into Optical Pedography: Development and Validation of a Novel Instrument: a Validation Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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. The whole process will be divided into distinct steps required for the targeted outcome, which includes:

  1. collecting visual data (podoscope foot pictures) and training a segmentation machine learning-based algorithm designed for recognizing only feet area, a total of atleast 30 participants performing 9 different standing positions - over 270 usable pictures for training and functionality validation
  2. collecting personal, visual and pressure data (participant weight, podoscope foot pictures, pedobarographic platform measurements) and training a machine/deep learning-based model designed for feet pressure distribution areas identification and quantification, a total of estimated 60 participants undergoing 5 alternating, as similar as possible, measurements on podoscope and pedobarographic platform
  3. evaluating the validity and reliability of a new plantar pressure measuring instrument following the same imaging procedure as described in step 2, a total of estimated 60 participants

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Czechia
      • Olomouc, Czechia, Czechia, 77900
        • Faculty of Health Sciences, Palacký University Olomouc, Czech Republic
        • Contact:
        • Principal Investigator:
          • Jonatan Dvořáček
        • Sub-Investigator:
          • Petr Konečný

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy individuals willing to participate in the study protocol

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Criterion validity of foot area measurement
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palacky University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UPOL-340091/1030S-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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