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SCANREP: Reliability of 3D Lower Limb Scanning

NCT04032041 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-01-10

Study results available
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Summary

3D limb scanning systems have recently been implemented for the clinical fitting of prosthetic and orthotic devices due to substantial decreases in costs. However, little data is available regarding the repeatability and validity of systems currently in use. In this study the investigators seek to evaluate the repeatability and validity of multiple lower limb measurements obtained using low-cost 3D limb scanning technology.

Conditions

  • Foot Injuries and Disorders

Interventions

DEVICE

Structure Sensor

A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.

DEVICE

Caliper

Caliper: An OriginCal IP54 digital caliper (Anytime Inc, Granada Hills, CA) was used to take three consecutive physical measurements in millimeters at each identified measurement location. For measurements outside of the caliper's scope a tape measure was used in place of the caliper. Physical measuring devices were reset to zero between each measure.

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Jason M Wilken, PT, PhD · University of Iowa

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2021-07-31
Completion
2022-07-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032041 on ClinicalTrials.gov