NCT06127316 The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
| NCT ID | NCT06127316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Iowa |
| Condition | Traumatic Lower Limb Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-16 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-08-16 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Jason M Wilken, PT,PhD
PRINCIPAL INVESTIGATOR
University of Iowa
Frequently Asked Questions
Who can join the NCT06127316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Traumatic Lower Limb Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06127316 currently recruiting?
Yes, NCT06127316 is actively recruiting participants. Contact the research team at jason-wilken@uiowa.edu for enrollment information.
Where is the NCT06127316 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT06127316 clinical trial?
NCT06127316 is sponsored by University of Iowa. The principal investigator is Jason M Wilken, PT,PhD at University of Iowa. The trial plans to enroll 20 participants.