3D Foot Scanner Reliability for Footwear Fit and Design

NCT ID: NCT05676619

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2024-04-14

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

Detailed Description

Evidence of reliability is essential for use of a 3D foot scanner in diabetes footwear fit evaluation and orthopaedic footwear design. The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers in order to: assess the 3D foot scanner's reliability. Specifically, the investigators will assess its variability during three repeated foot scans of the same subject's foot. Three half weightbearing foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient).

The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers (10 each) in order to assess the Elinvision 3D foot scanner's (i) intra-rater reliability through repeated foot scans (3 times each) and (ii) inter-rater reliability of these scans as carried out by two independent examiners whilst participants are half weightbearing to establish adequate reliability (0.80+ ICC) for use in subsequent diabetes footwear fit assessment and orthopaedic footwear design and manufacture.

Conditions

Diabetes Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single cohort of healthy volunteers

Single cohort of healthy volunteers

Group Type: OTHER

3D foot scanner

Intervention Type: DEVICE

Reliability of 3D foot scanner during repeated scans

Interventions

3D foot scanner

Reliability of 3D foot scanner during repeated scans

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra J Jones

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Locations

Leicester General Hospital

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

0865

Identifier Type: -

Identifier Source: org_study_id