Effect of Custom Dynamic Orthoses on Forefoot Loading (NCT06710119) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Custom Dynamic Orthoses on Forefoot Loading
United States60 participantsStarted 2025-06-18
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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