From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Jason Wilken
Summary
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.
Description
This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO. Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 8/1…
Interventions
- DeviceModular Carbon Fiber Custom Dynamic Orthosis (CDO)
The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
- DeviceMono Carbon Fiber Custom Dynamic Orthosis (CDO)
The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
Locations (5)
- Naval Medical Center San Diego - Clinical Biomechanics LaboratorySan Diego, California
- University of IowaIowa City, Iowa
- Minneapolis VA Health Care System - Motion Analysis LaboratoryMinneapolis, Minnesota
- Mayo Clinic - Motion Analysis LabRochester, Minnesota
- Vanderbilt University - Zelik Lab For Biomechanics & Assistive TechnologyNashville, Tennessee