Custom carbon-fiber dynamic orthosis to reduce forefoot loading
Effect of Custom Dynamic Orthoses on Forefoot Loading
NA · University of Iowa · NCT06710119
This study will test whether a custom carbon-fiber dynamic orthosis, with or without visual feedback training, can reduce forefoot loading in adults with below‑knee injuries who need a CDO.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Trial ID | NCT06710119 on ClinicalTrials.gov |
What this trial studies
Adults with function-limiting injuries below the knee who are prescribed a carbon-fiber custom dynamic orthosis (CDO) will walk without the device and at several time points after prescription, after randomized training with or without visual force feedback, and after a period of take-home use. Wireless in-shoe force sensors will record plantar pressures and loading patterns during gait to quantify initial offloading and changes over time. Participants will complete questionnaires on pain, comfort, satisfaction, and quality of life to compare patient-reported outcomes between groups. The study seeks to determine whether visual feedback during training or additional home use leads to further reductions in forefoot forces and improved patient experience.
Who should consider this trial
Good fit: Adults aged 18–65 with a function-limiting injury below the knee who require a carbon-fiber custom dynamic orthosis and can walk 25 feet without an assistive device are ideal candidates.
Not a fit: Patients with pain greater than 9/10 while walking, neurologic weakness from spinal cord or central nervous system pathology, or prescriptions that extend to the thigh or include a knee brace are unlikely to benefit from the study interventions.
Why it matters
Potential benefit: If successful, the approach could help clinicians prescribe CDOs and training that better reduce forefoot forces and improve patient comfort and function.
How similar studies have performed: Previous biomechanical studies show that orthoses and gait retraining can alter plantar loading, but the combination of carbon-fiber CDOs with real-time visual force feedback remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion criteria * Ages: 18-65 * Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis * Shoe size between women's 8 and 13.5 or men's 6.5 and 13 * Any of the following: weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment * Ability to walk 25 feet without using a cane or crutch * Ability to walk at a slow to moderate pace * Able to read and write in English and provide written informed consent Patient Exclusion criteria * Pain \> 9/10 while walking * Ankle weakness as a result of spinal cord injury or central nervous system pathology * AFO or CDO prescription that includes a knee brace or goes up to thigh * Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder) * Nerve, muscle, bone, or other condition limiting function of the contralateral extremity * BMI greater than 40 * Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing * Pregnancy
Where this trial is running
Iowa City, Iowa and 1 other locations
- University of Iowa — Iowa City, Iowa, United States (ACTIVE_NOT_RECRUITING)
- Cornerstone Prosthetics and Orthotics — Everett, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Jason M Wilken, PT, PhD
- Email: jason-wilken@uiowa.edu
- Phone: 319-335-6857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower Extremity Injuries, Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Visual Feedback, Foot Loading