3D Foot Scanner Reliability for Footwear Fit and Design
Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leicester, United Kingdom, LE5 4PW
- Leicester General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Single cohort of healthy volunteers
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Reliability of 3D foot scanner during repeated scans
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
Time Frame: Repeated scans at baseline
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(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;
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Repeated scans at baseline
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Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
Time Frame: Repeated scans at baseline
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(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
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Repeated scans at baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Petra J Jones, University Hospitals, Leicester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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