Comparing different designs of carbon fiber orthoses for comfort and mechanics

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

This study is testing how different designs of the top part of carbon fiber braces can affect comfort and movement for people with post-traumatic osteoarthritis and healthy individuals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT05456295 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of various proximal cuff designs on carbon fiber custom dynamic orthoses (CDOs) in individuals with post-traumatic osteoarthritis and healthy participants. The research aims to assess how these cuff designs affect patient comfort, limb mechanics, and the overall performance of the orthosis. Participants will undergo testing both without an orthosis and while wearing CDOs with four different cuff designs. The findings will help to better understand the role of cuff design in improving functional outcomes for patients with lower limb injuries.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 diagnosed with post-traumatic osteoarthritis of the ankle who can walk without assistance.

Not a fit: Patients with severe brain injuries, significant functional limitations, or those requiring stabilizing devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved comfort and functionality of carbon fiber orthoses for patients with lower limb injuries.

How similar studies have performed: While the use of carbon fiber orthoses is becoming more common, the specific examination of cuff design effects is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Iowa City, Iowa

• University of Iowa — Iowa City, Iowa, United States (Recruiting)

Study contacts

• Principal investigator: Jason M Wilken, PT, PhD — University of Iowa
• Study coordinator: Jason M Wilken, PT, PhD

Conditions Healthy; Lower Limb Injury; Post-Traumatic Osteoarthritis; Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics; Adult