Comparing Walking Function Between C-Leg and Bio Leg Powered Prosthetic Knees in Adults with Above-Knee Amputation

What this Trial Is About

This research aims to compare walking function in individuals with transfemoral amputations who currently use the C-Leg, a microprocessor-controlled prosthetic knee considered the clinical standard, to the function achieved when using the Bio Leg, a powered microprocessor prosthetic knee. The study addresses whether powered knee assistance offers additional benefits in movement quality, metabolic efficiency, and limb loading during walking tasks, which are critical for real-world mobility challenges. It seeks to provide objective evidence to inform prosthetic prescription, rehabilitation, and payment decisions for people with transfemoral amputation. Participants will first be assessed while using their current C-Leg prosthesis. After this initial assessment, they will be fitted with the Bio Leg prosthesis and wear it exclusively during a 4 to 6 week acclimation period. During this time, participants will attend 2 to 4 physical therapy sessions to train for prosthesis use. Following the acclimation period, participants will complete a second assessment similar to the first to compare performance between devices. Throughout the study, participants will undergo evaluations including a 6-minute walk test, measurements of walking symmetry through ground reaction forces, and metabolic efficiency assessments at baseline and after the acclimation period. These assessments will measure changes in mobility and energy use. The study lasts for the duration of the acclimation and assessment periods, with each participant serving as their own control to compare outcomes between the two prosthetic knees.

Bio Leg: Advancing Mobility (BAM)