From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Recruiting now · Not applicable
Conditions studied: Foot Injury
In brief
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.
Key facts
- Study ID
- NCT06352788
- Run by
- Jason Wilken
- People needed
- 35
- Starts
- 2024-07-02
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Naval Medical Center San Diego - Clinical Biomechanics Laboratory — San Diego, California, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- Minneapolis VA Health Care System - Motion Analysis Laboratory — Minneapolis, Minnesota, United States (enrolling)
- Mayo Clinic - Motion Analysis Lab — Rochester, Minnesota, United States (enrolling)
- Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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