Back to Trials
NCT06352788NARecruiting

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

Jason Wilken

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

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

Interventions

DEVICE

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

DEVICE

Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Foot Injury

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