Status:
RECRUITING
The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
Fabtech Systems
Conditions:
Traumatic Lower Limb Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 durin...
Detailed Description
Carbon fiber custom dynamic orthoses (CDOs) have been used to improve function, reduce pain, and offload the foot and ankle for individuals with a number of conditions affecting the lower extremity. C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06127316
Start Date
August 16 2024
End Date
June 1 2026
Last Update
December 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa
Iowa City, Iowa, United States, 52242