From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Start Date
7/2/2024
Completion Date
9/1/2028
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.
Detailed 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 in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Modular Carbon Fiber Custom Dynamic Orthosis (CDO)
Mono Carbon Fiber Custom Dynamic Orthosis (CDO)
Conditions
Locations
Naval Medical Center San Diego - Clinical Biomechanics Laboratory
San Diego, California 92134
United States
University of Iowa
Iowa City, Iowa 52242
United States
Minneapolis VA Health Care System - Motion Analysis Laboratory
Minneapolis, Minnesota 55417
United States
Mayo Clinic - Motion Analysis Lab
Rochester, Minnesota 55905
United States
Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
Nashville, Tennessee 37212
United States