Clinical trial NCT05676619: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Keywords: 3D foot scan
3D foot scanner
foot scan
reliability
repeatability
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2023-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
timeFrame: Repeated scans at baseline
measure: Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
timeFrame: Repeated scans at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
Study officials:
affiliation: University Hospitals, Leicester
name: Petra J Jones
role: PRINCIPAL_INVESTIGATOR
References: