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

Completed · Not applicable

Conditions studied: Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis

In brief

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.

Key facts

Study ID

NCT05456295

Run by

University of Iowa

People needed

35

Starts

2023-05-17

Expected to finish

2025-09-29

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Necrosis of any bones in the foot or ankle.
• Pain of 8/10 or greater during walking.
• Surgery on study limb anticipated in the next 6 months.
• Uncorrected visual or hearing impairments.
• Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities.
• Pregnancy
• Body mass index greater than 40.
• HEALTHY ABLE-BODIED PARTICIPANTS:
• Inclusion Criteria:
• Ages 18-65.
• Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
• Ability to hop without pain.
• Ability to perform a full squat without pain.
• 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).
• Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
• Medical conditions of injuries limiting function for greater than 6 weeks.
• Uncorrected visual or hearing impairments.

Where it is running

• University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.