Systematic Assessment of Prosthesis Stiffness on User Biomechanics Using the Lower Leg Trajectory Error Framework and Its Implication for the Design and Evaluation of Ankle-Foot Prostheses.

Advances in understanding the effects the mechanical characteristics of prosthetic feet on user biomechanics have enabled passive prostheses to improve the walking pattern of people with lower limb amputation. However, there is no consensus on the design methodology and criteria required to maximize specific user outcomes and fully restore their mobility. The Lower Leg Trajectory Error (LLTE) framework is a novel design methodology based on the replication of lower leg dynamics. The LLTE value evaluates how closely a prosthetic foot replicates a target walking pattern. Designing a prosthesis that minimizes the LLTE value, optimizes its mechanical function to enable users to best replicate the target lower leg trajectory. Here, we conducted a systematic sensitivity investigation of LLTE-optimized prostheses. Five people with unilateral transtibial amputation walked overground at self-selected speeds using five prototype energy storage and return feet with varying LLTE values. The prototypes' LLTE values were varied by changing the stiffness of the participant's LLTE-optimized design by 60%, 80%, 120%, and 167%. Users most closely replicated the target able-bodied walking pattern with the LLTE-optimized stiffness, experimentally demonstrating that the predicted optimum was a true optimum. Additionally, the predicted LLTE values were correlated to the user's ability to replicate the target walking pattern, user preferences, and clinical outcomes including roll-over geometries, trunk sway, prosthetic energy return, and peak push-off power. This study further validates the use of the LLTE framework as a predictive and quantitative tool for designing and evaluating prosthetic feet.