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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Iowa

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Carbon Fiber Custom Dynamic Orthosis (CDO)

Treatment groups

20 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Iowa

Lead sponsor

Fabtech Systems

Collaborator