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Which brace cuff is best? small study tests comfort and performance

NCT ID NCT05456295

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested four different cuff designs for carbon fiber ankle-foot orthoses (braces) in 35 healthy adults and people with ankle arthritis or injury. Researchers measured comfort, pain, foot pressure, and walking mechanics to see which cuff design people liked best. The goal is to improve brace design for better fit and function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carbon fiber custom dynamic orthosis (ankle-foot orthosis) with different cuff designs
What this could lead to
If successful, this could help design more comfortable and effective braces for people with ankle injuries or arthritis.
What could go wrong
This is a small, completed study with only 35 participants, so results may not apply to everyone. It focuses on short-term comfort and mechanics, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

May 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

PARTICIPANTS WITH PTOA: Inclusion Criteria: 1. Ages 18-65. 2. Diagnosis of ankle PTOA. 3. Ability to walk 50 feet at a slow to moderate pace. 4. Ability to walk without a cane or crutch. 5. Ability to read and write in English and provide written informed consent. Exclusion Criteria: 1. Diagnosis with a moderate or severe brain injury. 2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…). 3. Ankle weakness as a result of spinal cord injury or nervous system pathology. 4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity. 5. Rheumatoid or inflammatory arthritis. 6. Necrosis of any bones in the foot or ankle. 7. Pain of 8/10 or greater during walking. 8. Surgery on study limb anticipated in the next 6 months. 9. Uncorrected visual or hearing impairments. 10. Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities. 11. Pregnancy 12. Body mass index greater than 40. HEALTHY ABLE-BODIED PARTICIPANTS: Inclusion Criteria: 1. Ages 18-65. 2. Without current complaint of lower extremity pain, spine pain, open wounds or active infection. 3. Ability to hop without pain. 4. Ability to perform a full squat without pain. 5. Ability to read and write in English and provide written informed consent. Exclusion Criteria: 1. Diagnosis with a moderate or severe brain injury. 2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition). 3. Medical conditions or injuries that have limited participation in work or exercise in the last 6 months. 4. Medical conditions of injuries limiting function for greater than 6 weeks. 5. Uncorrected visual or hearing impairments. 6. Use of an assistive device. 7. Pregnancy 8. Body mass index greater than 35.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Iowa

    Iowa City, Iowa, 52241, United States

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