3D Foot Scanner Reliability for Footwear Fit and Design

University of Leicester

Status

Completed

Conditions

Diabetes Complications

Treatments

Device: 3D foot scanner

Study type

Interventional

Funder types

Other

Identifiers

NCT05676619

0865

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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