A $2,000,000 grant from the US Department of Defense’s (DoD) Congressionally Directed Medical Research Programs’ Orthotics and Prosthetics Outcomes Research Program has been awarded to a group of institutional collaborators to study fall-related health outcomes in lower-limb prosthesis users, including the largest clinical trial of microprocessor-controlled knees (MPKs) to-date. Collaborators include the Department of Clinical and Scientific Affairs at Hanger Clinic, Austin, TX, the University of Washington (UW), the University of Illinois at Chicago (UIC), and the Minneapolis Veterans Administration Health Care System (MVAHCS).
The project will be led by Brian Hafner, PhD (UW). Hanger Clinic’s Director of Clinical Research, Shane Wurdeman, PhD, CP, joins Andrew Sawers, PhD, CPO (UIC), and Sara Koehler-McNicholas, PhD (MVAHCS), as site leads. The first 2 aims are to develop and validate new outcome measures to better assess the impact of falls on individuals who use a lower limb prosthesis. The instruments designed and tested in these aims will be applied in aim 3, a pragmatic, randomized clinical trial to be conducted at Hanger Clinic.
The clinical trial will enroll 100 K2-level patients with transfemoral amputations from Hanger Clinic. (A K2-level ambulator has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.) Half will be randomized into an MPK, while the other half will be randomized to a non-MPK, which is the current standard for this K-level. Evidence from smaller scale studies suggests that this population could benefit from MPK technology; however, the level of evidence has not yet been sufficient to support coverage policies that would allow K2-level patients access to this type of technology.