The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
University of Iowa
20 participants
Aug 16, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria11
- 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
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Interventions
The carbon fiber custom dynamic orthoses (CDOs) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee. The CDO will be modular in design which will allow three carbon fiber struts of the same stiffness and differing lengths to be used to implement 0cm, 1cm, and 2cm levels of heel distraction height. A longer posterior strut will move the carbon fiber footplate away from the participants foot to create the heel distraction height.
Locations(1)
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NCT06127316