The Development of a Bimodal Walking-Running Prosthetic Foot

双模态步行-跑步假足的研制

基本信息

批准号：
10757119
负责人：
Jennifer Lynne Johansson
金额：
$ 114.29万
依托单位：
LIBERATING TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-19 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10757119
关键词：
Achievement Address Amputees Biomechanics Characteristics Clinic Code Data Development Devices Ensure Evaluation Exercise Failure Feedback Focus Groups General Population Goals Government Health Health Benefit Heel Height Home Hybrids Individual Industry Insurance Insurance Coverage Jogging Laboratories Learning Limb Prosthesis Limb structure Lower Extremity Manufactured basketball Marketing Measures Mental Health Modality Outcome Patient Self-Report Persons Phase Physical Fitness Physical activity Pilot Projects Preparation Prosthesis Prosthesis Design Respondent Running Specific qualifier value Sports Structure Surveys System Technology Testing Toes Validation Walking Weight cost design feasibility testing foot improved innovation limb amputation limb loss novel physical conditioning prevent primary outcome prosthetic foot prototype psychologic social social engagement verification and validation

项目摘要

PROJECT SUMMARY / ABSTRACT Over the course of this two-year Phase II effort, Liberating Technologies, Inc. (LTI), along with its collaborators at Fillauer Companies and Hanger Clinic, will refine, expand, and test a bimodal walking-running foot that would then be poised to become a viable commercial product that can be reimbursed under the existing L-code reimbursement structure. The goal of this project is to create a single foot that is optimized in each mode and comparable to a walking foot when in a walking mode and a running foot when in running mode. This novel foot would provide lower limb amputees who don’t currently have the access to running feet due to the lack of insurance coverage, the opportunity to participate in running and other running-based activities (e.g. basketball, etc.) to increase physical fitness. In doing so, the Caesar foot would also allow for the increased social participation and the physical and mental health benefits that are associated with these activities. In order to achieve this goal, we will progress and refine the bimodal foot technology with the achievement of the following objectives: (1) iterate and optimize the design of the bimodal foot to achieve a fully functional prototype ready for testing, (2) perform verification testing to confirm the prototype meets the design criteria, (3) validate the prototype in a pilot take-home trial and assess its impact on the physical activity of lower limb amputees, and (4) start preparing for an FDA submission for the Caesar foot. The outcomes will be data that verify and validate the bimodal foot device in the laboratory and in the real world. The product will be a highly advanced, commercially viable, verified, and validated bimodal prosthetic foot. This innovative design allows us to address both of the identified primary barriers preventing LLAs from taking part in these activities: 1) inadequately designed prostheses (by providing a foot with optimized design, alignment, and biomechanics in both walking and running modes) and 2) the lack of accessibility for higher activity prostheses (the cost of the foot would be covered by insurance).

项目概要/摘要在为期两年的第二阶段工作中，Liberating Technologies, Inc. (LTI) 及其合作者 Fillauer Companies 和 Hanger Clinic 的研究人员将改进、扩展和测试双模步行-跑步足部，该足部将然后准备成为可行的商业产品，可以根据现有的 L 代码进行报销该项目的目标是创造一种在每种模式下都得到优化的单脚。这种新颖的脚在步行模式下相当于步行脚，在跑步模式下相当于跑步脚。将为目前由于缺乏脚而无法跑步的下肢截肢者提供帮助保险、参加跑步和其他跑步活动（例如篮球、等）以增加足部的身体素质这样做，凯撒还可以增加社交能力。参与以及与这些活动相关的身心健康益处。为了实现这一目标，我们将不断进步和完善双模足技术，实现目标如下：（1）迭代优化双模足设计，实现功能齐全的原型准备测试，(2) 执行验证测试以确认原型符合设计标准，(3) 验证试点带回家试验中的原型并评估其对下肢截肢者身体活动的影响，以及 (4)开始准备Caesar足部的FDA申报。结果将是在实验室和现实世界中验证和验证双模足部设备的数据。该产品将是一种高度先进、具有商业可行性、经过验证和验证的双模假足。创新设计使我们能够解决阻碍 LLA 参与的两个已确定的主要障碍这些活动： 1) 设计不当的假肢（通过为脚提供优化的设计、对齐和步行和跑步模式下的生物力学）以及 2）缺乏更高活动度假肢的可及性（脚的费用将由保险承担）。