Actively Recruiting
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Led by Jason Wilken · Updated on 2026-01-15
35
Participants Needed
5
Research Sites
217 weeks
Total Duration
On this page
Sponsors
J
Jason Wilken
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.
CONDITIONS
Official Title
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 65
- At least 2 years since a traumatic injury below the knee
- Ability to be fitted with an orthosis
- Presence of any of the following:
- Weakness of ankle plantarflexors (less than 4/5 on manual muscle test)
- Limited pain-free ankle motion (dorsiflexion less than 10 degrees or plantarflexion less than 20 degrees)
- Mechanical pain with loading to hindfoot or midfoot (pain rating 4 or higher out of 10)
- Fusion or candidate for fusion of the ankle or hindfoot
- Candidate for amputation due to ankle or foot injury and impairment
You will not qualify if you...
- Pain greater than 8 out of 10 at rest
- Ankle weakness or spasticity caused by spinal cord injury or central nervous system disease
- Use of an orthosis including the knee
- Unable to walk
- Scheduled surgery on the study limb within the next 4 months
- Medical or psychological conditions affecting functional testing (e.g., severe brain injury, stroke, heart disease, vestibular disorder)
- Neurologic, musculoskeletal, or other problems limiting use of the opposite leg
- Uncorrected vision or hearing problems
- Pregnancy
- Non-English speaking
- Body mass index over 40
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Naval Medical Center San Diego - Clinical Biomechanics Laboratory
San Diego, California, United States, 92134
Actively Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Minneapolis VA Health Care System - Motion Analysis Laboratory
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
4
Mayo Clinic - Motion Analysis Lab
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
J
Jason M Wilken, PT, PhD
CONTACT
M
Molly S Pacha, MS, ATC, LAT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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