Trials / Completed
CompletedNCT05676619
3D Foot Scanner Reliability for Footwear Fit and Design
Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Leicester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 3D foot scanner | Reliability of 3D foot scanner during repeated scans |
Timeline
- Start date
- 2023-02-16
- Primary completion
- 2024-04-14
- Completion
- 2024-04-14
- First posted
- 2023-01-09
- Last updated
- 2024-05-08
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05676619. Inclusion in this directory is not an endorsement.