Evaluation of Powered Prosthetic Legs for Use with Transfemoral OI Recipients
Abstract
Objectives and Rationale: Over 1.8 million people currently live with amputations in the U.S. with 185,000 new amputations occurring annually. In both military and civilian populations, most of these amputations occur in the lower limb. Even when using state-of-the-art prosthetic devices, persons with an above-knee amputation use ~60% more energy when walking, which limits their mobility and interactions within the community. The combination of the physical limitations due to amputation and increased energy use can limit other everyday activities such as transitioning from sitting to standing, climbing stairs, or performing tasks of daily living. Technological advances have created powered leg devices, which for persons with above knee amputation, allow for coordinated movement of powered knee and ankle joints. However, these powered devices are heavier than passive devices and suspension and control of the devices from traditional prosthesis sockets can be challenging and unreliable. Targeted muscle reinnervation (TMR) surgery reroutes residual nerves to spare muscles, allowing for better readings for powered device control. Further, osseointegration (OI) surgery, which allows direct attachment of the prosthesis to the residual bone through an implant, helps to transfer the prosthesis weight to the skeleton, improving mobility, reducing energy use, and improving quality of life. Together, OI and TMR surgery has the potential to improve outcomes and user satisfaction for persons with an above-knee amputation using a powered leg device. The objective of this study is to evaluate functional mobility, powered prosthesis control, and device satisfaction for persons with an above-knee amputation who have received OI and TMR surgery using a powered leg prosthesis. Who It Will Help and How: The population of persons with limb loss is expected to triple by 2050, demonstrating a significant need for improved prosthesis options for military, Veteran, and civilian populations. While this research study will provide preliminary data, we expect this data to lead to a future clinical trial for further evaluation. We also expect the data on the impact of OI with and without TMR for functional outcomes, user satisfaction, and device control to be broadly applicable for other types of limb amputation, laying the groundwork for future studies to address these questions for other populations. Potential Clinical Applications, Benefits, and Risks: From our proposed study, we expect to obtain preliminary data for the following: (1) understand whether OI improves functional outcomes, energy use, and device satisfaction for persons with an above knee amputation compared to a traditional socket with a powered leg device and (2) determine whether EMG signals, the muscle readings used to control the powered prosthesis, are improved for OI recipients over a traditional socket with a powered leg device. These results will provide the foundation for a clinical trial that, if the data show benefits to OI, will allow for clinical adoption of OI for persons with an above-knee amputation and improved powered leg prosthesis control. Surgical risks are minimized by all medical care taking place at Northwestern’s state-of-the-art hospital. Clinical staff will be present for tests and training to minimize risks during these assessments. Project Timeline: Participants will be enrolled for ~13-15 months to allow full recovery between surgeries and testing. In our proposed 4-year timeline, we expect to enroll and complete outcomes tests for three participants. Upon completion, we will have obtained preliminary data on whether OI with a powered leg prosthesis can improve functional mobility outcomes and device satisfaction for persons with an above-knee amputation. How the Proposed Research Will Benefit Service Members, Veterans, Civilians, and Caregivers: In addition to the millions of civilians who have lower-limb amputations, the
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210850
Entities
People
- Levi J. Hargrove
Organizations
- Shirley Ryan AbilityLab
- United States Army