The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Launched by UNIVERSITY OF IOWA · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different heights of heel distraction (the space between the heel and the foot support) affect how the foot bears weight while walking, specifically for patients with traumatic lower limb injuries. Researchers want to understand how custom carbon fiber braces (called dynamic orthoses) can help reduce pain and improve comfort when walking. The study will compare these braces to see how well they work in lessening the pressure on different parts of the foot.

To participate in the trial, you must be between 18 and 65 years old and have a recent injury affecting your ankle or hindfoot, causing pain when you put weight on it. You should be able to walk 50 feet at a slow to moderate pace without the help of a cane or crutch. If you join the study, you can expect to wear a brace and participate in tests to see how it helps your walking and pain levels. This study is currently recruiting participants, and it aims to improve treatment options for people with similar injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 18-65 years
• • 2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
• • 3. Mechanical pain with limb loading (\>=4/10 on Numerical Pain Rating Scale)
• • 4. Ability to walk 50 feet at a slow to moderate pace
• • 5. Ability to walk without a cane or crutch
• • 6. 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, etc.
• • 3. Ankle weakness resulting from spinal cord injury or central 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. Uncorrected visual or hearing impairments
• • 9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
• • 10. Pregnancy
• • 11. Body mass index greater than 40 kg/m2