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Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Custom carbon-fiber dynamic orthosis to reduce forefoot loading

Official title: Effect of Custom Dynamic Orthoses on Forefoot Loading

Run by University of Iowa · NCT06710119 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Iowa
Academic / other
Locations2 sites (Iowa City, Iowa and 1 other locations)
StatusRecruiting
StartedJune 18, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedOctober 19, 2026
Trial IDNCT06710119 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Cornerstone Prosthetics and Orthotics
    Everett, Washington, United States     Recruiting
  • University of Iowa
    Iowa City, Iowa, United States     Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.