Home › NCT06710119
Effect of Custom Dynamic Orthoses on Forefoot Loading
Who can join
Ages 18 to 65 · All sexes
Full eligibility 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
About the study
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
What is being tested
- Visual Feedback (other)
Sponsor: University of Iowa · Participants: 60 · Started: Jun 18, 2025
Contact the study team
- Jason M Wilken, PT, PhD · Phone: 319-335-6857
- Kirsten M Anderson, PhD · Phone: 319-353-0431
Official record on ClinicalTrials.gov — NCT06710119
Locations in the U.S.
| Washington | Cornerstone Prosthetics and Orthotics, Everett |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.