From Opinion to Evidence: Multisite Evaluation of Custom Dynamic Orthosis Best Practices
Abstract
Service Members and civilians who suffer severe, traumatic lower leg injuries often have persistent pain, stiffness, and functional limitations that last for the rest of their lives. These injuries are common, significantly affect their ability to return to work, lead to high long-term disability costs, and result in increased rates of depression. This proposal for the Orthotics and Prosthetics Outcomes Research Program Clinical Trial Award addresses the need for significant advances in lower limb orthoses to return active Service Members, Veterans, and civilians suffering from severe lower leg trauma to active and productive lives. Recent military conflicts have resulted in many injuries, and over half of evacuated Service Members and two-thirds of injured Service Members who did not return to duty had extremity trauma. Civilian and military studies show individuals with severe limb trauma still have poor outcomes years after their injury. Traditional rehabilitative techniques used to restore function and quality of life after injury are often unable to overcome the limitations that result from scarring, deformity, and damage from the injury. Significant advances are needed to improve the function of these young, active Service Members. Over the last decade, our research team has shown that carbon fiber custom dynamic orthoses (CDOs) dramatically improve function after lower leg trauma in Service Members. CDOs consist of a cuff at or below the knee connected to a carbon fiber strut in the back that flexes and springs back to provide power to the individual as they walk or run, and a rigid foot plate that protects and supports the foot. Various CDO design factors have an impact on the ability of the device to improve function. We have demonstrated that alignment, the relative angle between the leg and foot, has the greatest effect on patient preference and limb mechanics. The current clinical process for providing CDOs is based on trial-and-error without a well-defined starting point, and our data indicate this leads to suboptimal devices. This likely contributes to incomplete recovery and some of the persistent deficits observed with CDO use. Providing CDOs with the proper initial configuration is expected to result in a preferred device that better restores limb function and improves satisfaction and mobility. This study aligns with the primary goal of the research program by providing data-driven guidance for CDO clinical care to better serve military personnel requiring lower limb orthoses. This study will use two distinct styles of CDOs, a stiff modular device and a more compliant monolithic device, and will evaluate a proposed optimal benchmark configuration along with three variants in a randomized order. The device configuration will be altered by changing alignment. They will be evaluated in a clinician preferred configuration, the proposed benchmark configuration, a variation with the ankle in more dorsiflexion (toes up) and a variation with the toes in greater plantarflexion (toes down). The use of commercially available devices produced at a central fabrication facility allows device standardization, a major limitation of prior studies with devices produced in less controlled fabrication environments. Up to 88 individuals who have limited function due to traumatic lower leg injury are expected to participate. During this study, participants will be randomized and fit to a single device, either modular or monolithic, by a formally trained clinician and given time to acclimate before being tested in each configuration. The two devices were selected because they represent the two most widely used CDO styles. Participants will wear one of the two device types and be given time to accommodate to each of the configurations, and the participants and individuals conducting the testing will not be informed of the specific condition being tested. Multiple well-established tests will be used to compare between
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210201
Entities
People
- Jason M. Wilken
Organizations
- United States Army
- University of Iowa