Effect of Custom Dynamic Orthoses on Forefoot Loading
ConditionLower Extremity Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Iowa
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Visual Feedback
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Iowa
Lead sponsor
Cornerstone Clinics, Everett, WA
Collaborator
Source ClinicalTrials.gov