3D Foot Scanner Reliability for Footwear Fit and Design

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design

Conditions
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Diabetes Complications

Intervention / Treatment
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* Device: 3D foot scanner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single cohort of healthy volunteers<br>Single cohort of healthy volunteers | Device: 3D foot scanner<br>* Reliability of 3D foot scanner during repeated scans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D foot scan, 3D foot scanner, foot scan, reliability, repeatability