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3D Foot Scanner Reliability for Footwear Fit and Design

Primary Purpose

Diabetes Complications

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
3D foot scanner
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Complications focused on measuring 3D foot scan, 3D foot scanner, foot scan, reliability, repeatability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Leicester General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single cohort of healthy volunteers

Arm Description

Single cohort of healthy volunteers

Outcomes

Primary Outcome Measures

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;
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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
May 11, 2023
Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT05676619
Brief Title
3D Foot Scanner Reliability for Footwear Fit and Design
Official Title
Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
September 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
3D foot scan, 3D foot scanner, foot scan, reliability, repeatability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single cohort of healthy volunteers
Arm Type
Other
Arm Description
Single cohort of healthy volunteers
Intervention Type
Device
Intervention Name(s)
3D foot scanner
Intervention Description
Reliability of 3D foot scanner during repeated scans
Primary Outcome Measure Information:
Title
Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
Description
(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
Title
Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
Description
(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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra J Jones
Phone
0116 258 4322
Email
pj100@leicester.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra J Jones
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane S Brela
Phone
0116 2584408
Email
jane.brela@uhl-tr.nhs.uk
First Name & Middle Initial & Last Name & Degree
Penelope Donley
Phone
0116 2584725
Email
penelope.donley@uhl-tr.nhs.uk
First Name & Middle Initial & Last Name & Degree
Petra Jones

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers

Learn more about this trial

3D Foot Scanner Reliability for Footwear Fit and Design

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