Computerized Prosthetic Alignment System (ComPAS)

描述（由申请人提供）： 这个SBIR快速通道项目将为下肢假肢对齐创建一个创新的新系统。 直接实时测量的力和力矩的基础上的posthetic插座将输入一个新开发的算法在计算机化的假体对齐系统（ComPAS）。它将有助于修复师在正确对齐的关键任务。 以前的研究人员已经明确指出需要这样一个系统，同时注意到使用仪器来帮助修复师改善修复体对齐的理论可行性。以前的努力没有产生一个成功的系统。基于初步的工作，我们相信我们的新方法可以成功地发展成为一个临床相关的，商业上可行的系统下肢假肢对齐。 ComPAS将是一个集成系统，易于使用和直观的假肢。它将是合理的定价，我们将寻求一个报销代码，其使用，使系统可以'支付自己。“它将几乎普遍应用于下肢假肢，而无需假肢专家的特殊调节，并可用于静态和动态情况。患者将被解除束缚，系统将在正常办公室或诊所环境中使用。步态参数的自动测量和解释将转化为用户友好的指标，向假肢专家指示如何改善假肢的对齐。 第一阶段的工作将侧重于建立原型硬件和软件，并展示我们的方法的有效性。第二阶段将完善物理包装和临床能力，并将对系统进行更广泛的科学验证。 第一阶段的工作将包括以下四个具体目标： 1.设计和构建原型CompPAS，2。优化对齐检测算法，3.使用概念验证ComPAS原型进行假体对线测试，4。临床审查。 第二阶段的工作将建立在第一阶段项目的结果和经验教训的基础上，该项目的重点是证明启发式方法的概念证明，该方法用于改进算法，以识别行走过程中从假肢接受腔底部收集的力和力矩数据的不对准。 临床假肢专家和其他假肢步态专家的第一阶段反馈也将用于指导第二阶段的开发。 第二阶段的工作将包括以下5个具体目标： 1.设计和构建兼容的ComPAS硬件，2。设计CompPAS软件接口，3.优化对齐检测算法，4.系统测试，5。制定最佳对齐的建议标准。 CYMA拥有一支杰出的团队，在假肢研究领域拥有超过62年的经验。 我们拥有该领域的具体知识以及成功完成拟议开发所需的技术和商业技能。

DESCRIPTION (provided by applicant): This SBIR Fast-Track project will create an innovative new system for lower limb prosthetic alignment. Direct real-time measurements of force and moment at the base of the posthetic socket will be input for a newly developed algorithm in the Computerized Prosthetic Alignment System (ComPAS). It will assist prosthetists in the critical task of proper alignment. Previous investigators have clearly indicated a need for such a system, while noting the theoretical feasibility of using instrumentation to help a prosthetist improve prosthetic alignment. Previous efforts have not produced a successful system. Based on preliminary work we believe our new approach can successfully be developed into a clinically relevant, commercially viable system for lower limb prosthetic alignment. ComPAS will be an integrated system that is easy to use and intuitive to the prosthetist. It will be reasonably priced and we will seek a reimbursement code for its use so the system can 'pay for itself.' It will have near universal application in lower limb prostheses without special accommodation by the prosthetist and be used in both static and dynamic situations. The patient will be untethered and the system will be used in a normal office or clinic environment. Automated measurement and interpretation of gait parameters will be translated into user-friendly indicators that indicate to the prosthetist how to improve the alignment of the prosthesis. Phase I work will focus on building prototype hardware and software and demonstrating the efficacy of our approach. Phase II will refine the physical packaging and clinical capabilities, and will undertake more extensive scientific validation of the system. Phase I work will be comprised of the following four Specific Aims: 1. Design and Build Prototype ComPAS, 2. Refine Alignment Detection Algorithm, 3. Prosthetic Alignment Testing Using Proof of Concept ComPAS Prototype, 4. Clinical Review. Phase II work will build from the results and lessons learned from the Phase I project which focused on demonstrating proof of concept of a heuristic method for refining an algorithm to recognize misalignment from force and moment data collected at the base of the prosthetic socket during walking. Phase I feedback from clinical prosthetists and other experts in prosthetic gait will also be used to guide Phase II development. Phase II work will consist of the following 5 Specific Aims: 1. Design and Build Definitive ComPAS Hardware, 2. Design ComPAS Software Interface, 3. Refine Alignment Detection Algorithm, 4. System Testing, 5. Develop Proposed Criteria for Optimal Alignment. CYMA has an exceptional team with over 62 combined years of experience in the field of prosthetic research. We have specific knowledge of the field and the technical and business skills required for successful completion of the proposed development.