From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
ConditionFoot Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJason Wilken
About this trial
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.
Eligibility criteria
Qualifiers
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
Weakness of ankle plantarflexors (<4/5 on manual muscle test)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Modular Carbon Fiber Custom Dynamic Orthosis (CDO)
- Mono Carbon Fiber Custom Dynamic Orthosis (CDO)
Treatment groups
35 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Jason Wilken
Lead sponsor
University of Iowa
Sponsor institution
Mayo Clinic
Collaborator
Vanderbilt University Medical Center
Collaborator
Navy Medical Center San Diego
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov