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
52 weeks
Total Duration
On this page
Sponsors
J
Jason Wilken
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how different designs of two types of carbon fiber custom dynamic orthoses (CDOs) affect recovery outcomes in adults who have experienced traumatic injuries to their lower legs. The study focuses on participants who continue to face challenges like weakness or limited movement more than two years after such injuries. The aim is to provide evidence to improve care by identifying the best orthosis configurations. Participants will be randomly assigned to use either a modular or a mono carbon fiber CDO. Each orthosis includes a full-length foot plate, a posterior carbon fiber strut, and a cuff that wraps around the leg below the knee. Participants will be evaluated without the orthosis and then with the orthosis in three different configurations: a proposed optimal setup, one with more dorsiflexion, and one with more plantarflexion. The order in which these configurations are tested will be randomized. During the study, participants will undergo multiple established tests to compare how well each configuration supports physical function, comfort, pain levels, and satisfaction. Measurements include walking and balance tests, pain rating scales, and assessments of ankle movement and power. Researchers will also monitor social participation and mood. The study runs until September 2028, with participants aged 18 to 65 involved in various assessments to measure the effects of the CDOs under different conditions.
CONDITIONS
Brief 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 from a traumatic injury below the knee
- Ability to be fit with a leg orthosis
- Presence of one or more of the following: ankle plantarflexor weakness, limited pain-free ankle motion, mechanical pain in hindfoot or midfoot, fusion or candidate for fusion of ankle or hindfoot, or candidate for amputation due to ankle/foot injury
You will not qualify if you...
- Pain greater than 8 out of 10 at rest
- Ankle weakness or spasticity from spinal cord injury or central nervous system disease
- Use of an orthosis including the knee
- Unable to walk
- Surgery planned on the injured leg within the next 4 months
- Medical or psychological conditions affecting functional testing such as severe brain injury, stroke, heart disease, or balance disorders
- Conditions limiting function of the opposite leg
- Uncorrected vision or hearing problems
- Pregnancy
- Non-English speaking
- Body mass index greater than 40
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants are fit with a custom dynamic orthosis (CDO) using either a modular or monolithic design.
1 visit (in-person)
Duration - Short-term evaluation period during the visit
Participants are evaluated without the CDO and with the CDO in three different configurations in a randomized order to compare outcomes.
1 visit with multiple assessments
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
M
Molly S Pacha, MS, ATC, LAT
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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