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

Description

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.

Conditions

Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ages 18-65.
  • 2. Diagnosis of unilateral 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.
  • 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Iowa,

Jason M Wilken, PT, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2026-09