Fall-Related Health Outcomes in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-Controlled Prosthetic Knees
Abstract
Objective: Computerized prosthetic knees include advanced features that provide a user with greater control and stability than traditional mechanical knees. Although research suggests that computerized knees reduce the number of falls a prosthesis user may experience, we do not know whether the increased safety provided by these knees affects a user’s ability to engage in meaningful activities. The objective of this project is therefore to determine whether using a computerized knee can change a user’s perception about the activities they can safely perform, and whether their concerns about safety limit involvement in desirable life situations. Because the tools available to assess the impact of a knee on a user’s safety and life are not ideal for people with amputation, we must first create new surveys to measure fall-related health outcomes. To do this, we will create new questions with input from clinicians, researchers, and prosthesis users. We will then test the questions in a large population of prosthesis users, and use the data to create better short surveys. In a separate study, we will test the new surveys along with existing surveys to see which of these surveys work best. Lastly, we will use the surveys in a clinical trial of people receiving either a computerized or non-computerized knee in their prosthesis. Outcomes of this project will include new surveys that can be used in clinical care and research, new information about which fall-related surveys perform best with prosthesis users, and new knowledge about how prosthetic knees affect users’ fall-related health. Rationale: Patient-reported outcome measures are surveys developed to help clinicians and researchers measure important health outcomes from the perspective of the individual receiving care. These surveys therefore contribute valuable information to a clinical assessment, and complement information obtained from physical examinations, diagnostic tests, physical performance measures, and wearable sensors. Use of patient-report surveys is particularly recommended for measuring complex outcomes, like fall-related self-efficacy or interference in life activities, which are challenging, if not impossible, to measure using other means. Although several surveys have been developed to measure fall-related health in people without amputation, none are entirely suitable for measuring people who use prostheses. This prevents clinicians and researchers from studying fall-related health outcomes in people with amputation and documenting the possible safety benefits of prosthetic technologies like computerized knees. The proposed research is therefore critically important to improving our ability to measure how modern prosthetic technologies affect important patient outcomes. Applicability and Impact of Research: The proposed research is directly relevant to the care and treatment of Service members, Veterans, and civilians who have experienced lower limb amputation. Better measurement of fall-related health outcomes is needed to guide clinical decisions, choose appropriate prosthetic componentry, evaluate the effectiveness of rehabilitation interventions, and improve standardization of outcomes assessment. Surveys we have previously developed are used by researchers and clinicians worldwide, including those at U.S. Department of Veterans Affairs (VA) Hospitals, VA Regional Amputation Centers and Polytrauma/Amputation Network Sites, and U.S. Military rehabilitation facilities. We believe that the surveys developed for this study will have a similar, positive impact on our field, and advance our understanding of fall-related health among people with lower limb amputation – an issue that is presently understudied and poorly understood. Patients Who Will Be Aided by the Research: We believe this research will benefit all Service members, Veterans, and civilians who use a lower limb prosthesis. While only 50%-60% of prosthesis users fall re
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010197
Entities
People
- Brian J Hafner
Organizations
- United States Army
- University of Washington