3D Foot Scanner Reliability for Footwear Fit and Design

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Complications
• Intervention / Treatment: Device: 3D foot scanner

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE5 4PW
    • Leicester General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single cohort of healthy volunteers	Device: 3D foot scanner; Reliability of 3D foot scanner during repeated scans

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester
• Investigators: Principal Investigator: Petra J Jones, University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): April 14, 2024
• Study Completion (Actual): April 14, 2024

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: reliability; 3D foot scan; 3D foot scanner; foot scan; repeatability
• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Mellitus; Diabetes Complications
• Other Study ID Numbers: 0865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No