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Completed

NCT Number: NCT05676619

3D Foot Scanner Reliability for Footwear Fit and Design

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D foot scanner

Device

Reliability of 3D foot scanner during repeated scans

Primary outcomes

  1. Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)

    Time frame: 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;

  2. Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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