Actively Recruiting
The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
Led by University of Iowa · Updated on 2026-01-15
20
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
Sponsors
U
University of Iowa
Lead Sponsor
F
Fabtech Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18-65 years
- Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
- Mechanical pain with limb loading (≥4/10 on Numerical Pain Rating Scale)
- Ability to walk 50 feet at a slow to moderate pace
- Ability to walk without a cane or crutch
- Ability to read and write in English and provide written informed consent
You will not qualify if you...
- Diagnosis with a moderate or severe brain injury
- Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.)
- Ankle weakness resulting from spinal cord injury or central nervous system pathology
- Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
- Rheumatoid or inflammatory arthritis
- Necrosis of any bones in the foot or ankle
- Pain of 8/10 or greater during walking
- Uncorrected visual or hearing impairments
- Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
- Pregnancy
- Body mass index greater than 40 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
J
Jason M Wilken, PT, PhD
CONTACT
K
Kirsten M Anderson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
4
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