3D Foot Scanner Reliability for Footwear Fit and Design

University of Leicester20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetes Complications

Interventions

3D foot scannerDEVICE

Reliability of 3D foot scanner during repeated scans

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Leicester General Hospital

Leicester, United Kingdom

Outcomes

Primary Outcomes

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;

Time frame: 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

Time frame: Repeated scans at baseline

Data from ClinicalTrials.gov

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