STTR Phase I: A Novel Prescription Process that Customizes Prosthetic Feet for Individual Patients

这个小企业技术转让（STTR）第一阶段项目的更广泛的影响/商业潜力是一个提供定制假肢脚的新过程。目前的处方方法根据患者的体重和身体活动水平为患者匹配假肢脚设计。然而，这种方法往往忽略了患者在姿势和行走步态方面的可变性，并导致次优的力分布和生物力学的不匹配。 这些问题反过来又导致了许多潜在的慢性问题，包括步态、平衡问题。和痛苦.该系统旨在开发一种新型的装配系统和制造工艺，以提供基于优化的机械应力分布模型的定制假肢脚。该系统旨在使每年使用假肢的420，000名高度活跃的美国患者受益。该STTR第一阶段项目将通过开发一种新的处方方法来开发定制假肢脚，以满足临床需求。该新方法利用具有可调节刚度特性的假足模型结合优化算法来确定个体患者的定制假足设置。定制的假脚将被制造和安装用于个别患者。然后，将在有限的概念验证研究中对假肢进行验证，以证明运动学和动力学行为的改善。 该奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is a novel process for providing customized prosthetic feet. Current prescription methods match patients with prosthetic feet designs based on the patient’s weight and level of physical activity. However, this method often neglects patient variabilities in terms of posture and walking gait and results in suboptimal force distribution and a mismatch in biomechanics. These problems, in turn, result in a multitude of potential chronic issues including issues with gait, balance. and pain. This proposed system aims to develop a novel fitting system and fabrication process to provide customized prosthetic feet based on optimized mechanical stress distribution models. The system aims to benefit the 420,000 highly active US patients who utilize prosthetic feet each year. This STTR Phase I project will address a clinical need by developing a novel prescription approach to developing custom prosthetic feet. The novel process utilizes a prosthetic foot model with adjustable stiffness properties in conjunction with an optimization algorithm to determine individual patient’s customized prosthetic foot settings. Custom prosthetic feet will be fabricated and fitted for use in individual patients. The prosthetics will then be validated in a limited proof of concept study to demonstrate improvements to kinematic and kinetic behaviors. The goals are to closely match the participant's intact ankle and foot measurements and to improve patient satisfaction outcomes.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.