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

Who can join

Ages 18 to 65 · All sexes

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

About the study

Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.

What is being tested

• Carbon Fiber Custom Dynamic Orthosis (CDO) (device)

Sponsor: University of Iowa · Participants: 20 · Started: Aug 16, 2024

Contact the study team

• Jason M Wilken, PT, PhD · Phone: 3193356857
• Kirsten M Anderson, PhD · Phone: 3193530431

Official record on ClinicalTrials.gov — NCT06127316

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.