The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb
Abstract
An estimated 20,000 military Service members sustained extremity injury in the recent wars in Iraq and Afghanistan. This high number of limb injured Service personnel catalyzed advancements in lower limb bracing technology and a focus on therapy to maximize utilization of these devices. The primary objective of this clinical trial is to determine if different types of leg/foot braces will improve comfort and function in persons who have sustained injury affecting their lower limb. This is a considerable problem in the Veteran and private sectors as well. It is presently unclear whether these newer (i.e., advanced) braces improve comfort and function in those with limb injury compared to bracing options formerly in use. The cost of newer devices and the associated fabrication time is rapidly climbing, and some reimbursors are not paying for these newer devices. For instance, a conventional ankle-foot-orthosis has a reimbursable cost of approximately $1400. Alternatively, newer advanced bracing systems, such as the Intrepid Dynamic Exoskeletal Orthosis (IDEO), are approximately twice the cost of conventional devices to fabricate. Reimbursement costs are not yet widely agreed upon, if accepted at all. If the devices truly improve function and comfort, then the initial high costs of provision may be justified. Further, it is possible that the ability for a brace to enable improved function is partly related to the physical abilities (i.e., functional level) of the user. There is sparse data available to inform clinical providers as it relates to these issues, thereby further justifying the conduct of this much needed study. Military treatment facilities are providing these devices. In spring of 2015, the Department of Veterans Affairs (VA) began actively ramping up capacity to provide advanced bracing technologies. The VA planned (1) to provide advanced bracing for those determined to need them and (2) to continue provision for those who received them during their time in military service. The VA organized training sessions (didactic and hands-on), a bracing subject matter expert (SME) group, formulated clinical brace recommendations, maintains a monthly call for the SME group, devised an outcome assessment protocol and has organized five advanced bracing clinics within VA (FL, NY, CO, CA, MN). This study will capitalize on the building and established bracing infrastructure within the VA and Hanger Clinics systems to answer these important clinical questions. It will primarily recruit from the Veteran and civilian sectors to ensure recruitment of eligible subjects from multiple sites. As Service personnel separate from the military and enroll in VA benefits, their bracing, therapies, and associated care will come from military treatment facilities, VA, and the private sector. Additionally, an estimated 25,000-35,000 non-military persons experience limb trauma annually. Currently, both groups of individuals, those with a history of military service and those without, experience healthcare interventions without a robust evidentiary basis. This study will begin to build the evidence to inform clinical decision-making about which device, advanced or conventional, maximizes patient comfort and function following extremity injury and identification as someone who could benefit from bracing technology. The study is immediately clinically applicable as it will be conducted within existing bracing clinical infrastructures. It will facilitate a new discussion about evaluating patients who use braces through the lens of an ambulatory functional level. It will also facilitate the use of objective outcome measurements within the participating clinical systems. Upon the conclusion of the study, the use of appropriately selected devices within each of the larger device categories (i.e., traditional or advanced) will yield conclusions regarding which device type optimizes patient performance and comfort within a given am
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610738
Entities
People
- Jason Highsmith
Organizations
- United States Army
- University of South Florida