3D Foot Scanner Reliability for Footwear Fit and Design

NCT05676619 | Completed

• 1 other identifier: 0865
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will carry out a proof-of-concept study in 20 adult healthy male and female volunteers in order to: assess a 3D foot scanner's reliability. Specifically, the investigators will assess its variability during repeated foot scans of the same subject's foot. Three repeated foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient

Conditions

Diabetes Complications

Keywords

3D foot scan; 3D foot scanner; foot scan; reliability; repeatability

Outcome Measures

Primary Outcomes (2)

• Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)

  (i) Intrarater reliability (Intraclass Correlation Coefficient) based on three scans of the same subject's foot whilst half-weightbearing carried out by the same 'rater' i.e. person using the 3D foot scanner;

  Repeated scans at baseline

• Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)

  (ii) Interrater reliability (Intraclass Correlation Coefficient) based on three scans of the same subject's foot first by one rater (as above) and then by a second rater

  Repeated scans at baseline

Study Arms (1)

Single cohort of healthy volunteers

OTHER

Single cohort of healthy volunteers

Device: 3D foot scanner

Interventions

3D foot scanner DEVICE

Reliability of 3D foot scanner during repeated scans

Single cohort of healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women aged 18 years or over
• Able to walk unaided
• Able to walk up steps (the 3D scanner requires a small step on to the device to enter the correct position for measurement)
• Willingness and capacity to participate in the study and to sign the informed consent form

You may not qualify if:

• Diabetes mellitus diagnosis
• Inability to ambulate independently without walking aids
• No obvious foot deformities
• No history of foot surgery
• No pain, injuries or medical conditions affecting the legs or lower back
• Any issues around balance (participants must remain standing in position for the approximately fifteen seconds required to obtain the 3D scan of their feet)
• Health conditions that impact foot morphology

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Petra J Jones

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 9, 2023
• Study Start: February 16, 2023
• Primary Completion: April 14, 2024
• Study Completion: April 14, 2024
• Last Updated: May 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)