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Abstract A novel, high-performance, cosmetic, rugged, appropriately costed, and mass-manufacturable prosthetic foot for use in low-income countries was designed and field tested. This ruggedized foot was created to accommodate the unique economic, environmental, and cultural requirements for users in India. A previous prototype that enabled able-bodied like gait was modified to include a durable cosmetic cover without altering the tuned stiffness of the overall foot. After undergoing mechanical benchtop testing, the foot was distributed to prosthesis users in India to for at least 5 months. Afterward, participants underwent clinical tests to evaluate walking performance, and additional benchtop testing was performed on the field-tested feet to identify changes in performance. The ruggedized foot endured 1 × 106 fatigue cycles without failure and demonstrated the desired stiffness properties. Subjects walked significantly faster (0.14 m/s) with the ruggedized foot compared to the Jaipur foot, and the feet showed no visible sign of damage after months of use. Additionally, the field-tested feet showed little difference in stiffness from a set of unused controls. Anecdotal feedback from the participants indicated that the foot improved their speed and/or walking effort, but may benefit from more degrees-of-freedom about the ankle. The results suggest that the foot fulfills its design requirements; however, further field testing is required with more participants over a longer period to make sure the foot is suitable for use in developing countries.more » « less
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Abstract 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.more » « less
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Abstract The walking pattern and comfort of a person with lower limb amputation are determined by the prosthetic foot’s diverse set of mechanical characteristics. However, most design methodologies are iterative and focus on individual parameters, preventing a holistic design of prosthetic feet for a user’s body size and walking preferences. Here we refined and evaluated the lower leg trajectory error (LLTE) framework, a novel quantitative and predictive design methodology that optimizes the mechanical function of a user’s prosthesis to encourage gait dynamics that match their body size and desired walking pattern. Five people with unilateral below-knee amputation walked over-ground at self-selected speeds using an LLTE-optimized foot made of Nylon 6/6, their daily-use foot, and a standardized commercial energy storage and return (ESR) foot. Using the LLTE feet, target able-bodied kinematics and kinetics were replicated to within 5.2% and 13.9%, respectively, 13.5% closer than with the commercial ESR foot. Additionally, energy return and center of mass propulsion work were 46% and 34% greater compared to the other two prostheses, which could lead to reduced walking effort. Similarly, peak limb loading and flexion moment on the intact leg were reduced by an average of 13.1%, lowering risk of long-term injuries. LLTE-feet were preferred over the commercial ESR foot across all users and preferred over the daily-use feet by two participants. These results suggest that the LLTE framework could be used to design customized, high performance ESR prostheses using low-cost Nylon 6/6 material. More studies with large sample size are warranted for further verification.more » « less
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