Actively Recruiting
Effect of Custom Dynamic Orthoses on Forefoot Loading
Led by University of Iowa · Updated on 2025-12-31
60
Participants Needed
2
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
University of Iowa
Lead Sponsor
C
Cornerstone Clinics, Everett, WA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Custom Dynamic Orthoses on Forefoot Loading
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Iowa
Iowa City, Iowa, United States, 52241
Active, Not Recruiting
2
Cornerstone Prosthetics and Orthotics
Everett, Washington, United States, 98225
Actively Recruiting
Research Team
J
Jason M Wilken, PT, PhD
CONTACT
K
Kirsten M Anderson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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