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

这个小型企业技术转让(STTR)第一阶段项目的更广泛的影响/商业潜力是提供定制假肢的新工艺。目前的处方方法根据患者的体重和体力活动水平将患者与假肢设计进行匹配。然而，这种方法往往忽略了患者在姿势和行走步态方面的差异，导致了次优的力分布和生物力学上的不匹配。这些问题反过来又会导致许多潜在的慢性问题，包括步态和平衡问题。和痛苦。该系统旨在开发一种新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。该系统旨在使每年使用假肢的42万名高度活跃的美国患者受益。这个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来满足临床需求。这一新颖的工艺利用具有可调节硬度特性的假肢模型，并结合优化算法来确定个别患者的定制假肢设置。定制的假肢将被制造和安装，以供个别患者使用。假体随后将在有限的概念验证研究中得到验证，以证明运动学和运动学行为的改善。这个奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.