TerminatedNot Applicable

SCANREP: Reliability of 3D Lower Limb Scanning

Stopped: No participants were enrolled for group 2. Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.

United States30 participantsStarted 2019-09-27

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

GROUP 1 Patient Inclusion criteria * Ages: 18-75 * Healthy individuals without a current complaint of lower extremity pain, spine pain, active infections or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months * Ability to perform a full squat without pain * Able to read and write in English and provide written informed consent Patient Exclusion criteria * Diagnosed moderate or severe brain injury * Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Current complaint of pain or numbness in the spine * Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing * Require an assistive device * Open/unhealed wounds on lower extremity. * BMI greater than 35 GROUP 2 Patient Inclusion criteria * Ages: 18-75 * Daily AFO use to address unilateral below knee functional deficits (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease) * Ability to stand independently without use of an assistive device (Cane, crutch, etc) * Ability to safely bear full body weight on affected limb without use of an AFO or other protection * Able to read and write in English and provide written informed consent Patient Exclusion criteria * Use of an AFO that crosses the knee (includes Knee brace or similar) * Open/unhealed wounds on lower…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Width of the Metatarsal Heads (Minimal Detectable Change [MDC])

Timeframe: Less than 2 days

Width of the Metatarsal Heads (Pearson's Correlation Coefficient)

Timeframe: Less than 2 days

Width of the Metatarsal Heads (Mean Root Mean Square [RMS] Difference)

Timeframe: Less than 2 days

Width of the Calcaneus (Minimal Detectable Change [MDC])

Timeframe: Less than 2 days

Width of the Calcaneus (Pearson's Correlation Coefficient)

Timeframe: Less than 2 days

Width of the Calcaneus (Mean Root Mean Square [RMS] Difference)

Timeframe: Less than 2 days

Foot Length (Minimal Detectable Change [MDC])

Timeframe: Less than 2 days

Trial details

NCT IDNCT04032041

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-31

Results submitted2022-07-12

View on ClinicalTrials.gov More Foot Injuries and Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Width of the Metatarsal Heads (Minimal Detectable Change [MDC])

Timeframe: Less than 2 days

Width of the Metatarsal Heads (Pearson's Correlation Coefficient)

Timeframe: Less than 2 days

Width of the Metatarsal Heads (Mean Root Mean Square [RMS] Difference)

Timeframe: Less than 2 days

Width of the Calcaneus (Minimal Detectable Change [MDC])

Timeframe: Less than 2 days

Width of the Calcaneus (Pearson's Correlation Coefficient)

Timeframe: Less than 2 days

Width of the Calcaneus (Mean Root Mean Square [RMS] Difference)

Timeframe: Less than 2 days

Foot Length (Minimal Detectable Change [MDC])

Timeframe: Less than 2 days