Diabetes Complications
Conditions
Keywords
3D foot scan, 3D foot scanner, foot scan, reliability, repeatability
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.
Interventions
DEVICE3D foot scanner
Reliability of 3D foot scanner during repeated scans
Sponsors
University Hospitals, Leicester
University of Leicester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change) | Repeated scans at baseline | (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) | Repeated scans at baseline | (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 |
Countries
United Kingdom
Outcome results
None listed