Clinical Outcomes Associated with At-Home Use of Passive MPKs vs. Two Different Powered Prosthetic Knees by K4-Level Individuals with Transfemoral Amputations
Abstract
Transfemoral amputation (TFA) results in significant changes in the body that impact function, including during activities essential for community living. Individuals with TFA have been shown to use more energy to walk, walk slower, fall and stumble more, have decreased balance and activity levels, as well as have difficulty walking on slopes, stairs, and uneven terrain. In addition, persons with TFA are at much greater risk of developing long-term health problems, such as osteoarthritis, osteoporosis, higher rates of hip replacement surgeries, low back pain, weight gain, and cardiovascular disease. These increased risks have been associated with the effects of utilizing passive prostheses, which are unable to restore the power at the knee and ankle joints needed for typical biological gait. Powered prosthetic knees have the potential to restore lost knee power and have been shown to improve performance and balance as well as reduce exertion in persons with TFA. However, nearly all studies of powered prosthetic knee joints have been conducted in a laboratory instead of out in the real world. In addition, there are different strategies employed by different powered knees to achieve improved function, with some designed to be heavier and more functional while others provide less power to achieve a lower weight. Therefore, the objective of the proposed study is to investigate the tradeoffs between two powered knees (one that is more powerful, but heavier and another that is lighter, but less powerful) and traditional passive micro-processor controlled knees to evaluate the effect of the different knees on patients’ mobility, safety, and well-being outside of the laboratory. These data will identify the knee that is best suited for active users during different tasks as determined by measured, observed, and self-reported outcomes achieved. Ultimately, the purpose for different versions of the powered knees is to fit the right device to each person’s needs. The goal of this proposed project is to gather community-based data from the highly active (K4) TFA population to provide evidence for the prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient group) for this group. We envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a broader patient population that includes less active subjects (K2-K4) to guide the implementation of effective prescriptions towards those patients that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most efficient use of DoD and Veteran’s Affairs (VA) healthcare dollars. This proposal’s potential clinical applications and benefits are to (1) provide evidence to guide the prescription and use of powered knee technologies for highly active individuals, (2) provide data to help plan a larger clinical trial to guide prescription of powered knee technologies to other activity levels to maximize patient benefit while optimizing device cost and thereby influencing clinical practice and informing policy decisions, and (3) provide data that can be disseminated to other researchers to inform the design of future powered prosthetic knees by understanding the needs of users and identifying the features and functions that are most valuable to this patient population as well as the capabilities and limitations of current devices. While these studies are focused on DoD and VA patients, this research is ultimately applicable to, and has the potential to benefit, all individuals with TFA including the American civilian population as well. Data from the Amputee Coalition of America and published research can be used to estimate that there are approximately 450,000 individuals in the United States with a TFA. The family members and caregivers of this population will ideally also receive residual benefits by identifying which knees
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110350
Entities
People
- Jennifer Johansson
Organizations
- Liberating Technologies (United States)
- United States Army