🔎 Trials Near Me

Home › Foot Injuries and Disorders › NCT06352788

From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

Recruiting

Who can join

Ages 18 to 65 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Between the ages of 18 and 65
* 2 or more years from a traumatic injury below the knee
* Ability to be fit with an orthosis
* Any of the following:

  * Weakness of ankle plantarflexors (\<4/5 on manual muscle test)
  * Limited pain-free ankle motion (dorsiflexion (DF) \<10° or plantarflexion (PF) \<20°)
  * Mechanical pain with loading to hindfoot/midfoot (\>=4/10 Numerical pain rating scale)
  * Fusion or candidate for fusion of the ankle or hindfoot
  * Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion Criteria:

* Pain greater than 8/10 at rest
* Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
* Use of an orthosis including the knee
* Non-ambulatory
* Surgery on study limb anticipated in next 4 months
* Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
* Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
* Uncorrected visual or hearing impairments
* Pregnancy
* Non-English speaking
* BMI \> 40

About the study

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.

What is being tested

Sponsor: Jason Wilken · Participants: 35 · Started: Jul 2, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06352788

Locations in the U.S.

CaliforniaNaval Medical Center San Diego - Clinical Biomechanics Laboratory, San Diego
IowaUniversity of Iowa, Iowa City
MinnesotaMinneapolis VA Health Care System - Motion Analysis Laboratory, Minneapolis
Mayo Clinic - Motion Analysis Lab, Rochester
TennesseeVanderbilt University - Zelik Lab For Biomechanics & Assistive Technology, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.