CompletedNot Applicable

Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics

United States35 participantsStarted 2023-05-17

Plain-language summary

Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.

Who can participate

Age range

18 Years – 65 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.

Inclusion criteria

. Ages 18-65.
. Diagnosis of ankle PTOA.
. Ability to walk 50 feet at a slow to moderate pace.
. Ability to walk without a cane or crutch.
. Ability to read and write in English and provide written informed consent.

Exclusion criteria

. Diagnosis with a moderate or severe brain injury.
. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).

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

Peak Plantar Force (total foot)

Timeframe: Baseline

Plantar Force Impulse (total foot)

Timeframe: Baseline

Peak Plantar Force (forefoot)

Timeframe: Baseline

Plantar Force Impulse (forefoot)

Timeframe: Baseline

Peak Plantar Force (midfoot)

Timeframe: Baseline

Plantar Force Impulse (midfoot)

Timeframe: Baseline

Peak Plantar Force (hindfoot)

Timeframe: Baseline

Plantar Force Impulse (hindfoot)

Timeframe: Baseline

Trial details

NCT IDNCT05456295

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-29

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 65 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.

Inclusion criteria

. Ages 18-65.
. Diagnosis of ankle PTOA.
. Ability to walk 50 feet at a slow to moderate pace.
. Ability to walk without a cane or crutch.
. Ability to read and write in English and provide written informed consent.

Exclusion criteria

. Diagnosis with a moderate or severe brain injury.
. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).

What they're measuring

Peak Plantar Force (total foot)

Timeframe: Baseline

Plantar Force Impulse (total foot)

Timeframe: Baseline

Peak Plantar Force (forefoot)

Timeframe: Baseline

Plantar Force Impulse (forefoot)

Timeframe: Baseline

Peak Plantar Force (midfoot)

Timeframe: Baseline

Plantar Force Impulse (midfoot)

Timeframe: Baseline

Peak Plantar Force (hindfoot)

Timeframe: Baseline

Plantar Force Impulse (hindfoot)

Timeframe: Baseline