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 range18 Years – 65 Years

SexALL

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…).
✕. Ankle weakness as a result of spinal cord injury or nervous system pathology.
✕. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
✕. Rheumatoid or inflammatory arthritis.

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

Numerical Pain Rating Scale

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 range18 Years – 65 Years

SexALL

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…).
✕. Ankle weakness as a result of spinal cord injury or nervous system pathology.
✕. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
✕. Rheumatoid or inflammatory arthritis.

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

Numerical Pain Rating Scale

Timeframe: Baseline