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

Launched by UNIVERSITY OF IOWA · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how different designs of a special leg brace called a carbon fiber custom dynamic orthosis (CDO) can affect comfort, preference, and how the leg works when walking. The CDO is made of a lightweight material that helps support the leg while allowing for natural movement. The focus of the study is on the part of the brace that wraps around the leg just below the knee, as it may have a big impact on how comfortable it feels and how well it functions.

To participate in this trial, you need to be between 18 and 65 years old. If you have post-traumatic osteoarthritis in your ankle, you should be able to walk 50 feet without assistance and not have severe pain. If you are healthy and have no current leg or back pain, you might also be eligible. Participants will be asked to wear the CDO and share their thoughts on comfort and how it affects their walking. This research is important as it may help improve the design of leg braces for better comfort and performance.

Gender

ALL

Eligibility criteria

• 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.