Computerized Prosthetic Alignment System (ComPAS)

描述(由申请人提供)： 这一SBIR快速通道项目将创建一种创新的双腿假肢对齐新系统。 直接实时测量假体窝底部的力和力矩将被输入到计算机化假体对准系统(COMPAS)中新开发的算法中。它将帮助修复师完成正确对准的关键任务。 以前的研究人员已经明确指出了这种系统的必要性，同时指出了使用器械帮助假肢医生改善假体对准的理论上的可行性。之前的努力没有产生一个成功的系统。在前期工作的基础上，我们相信我们的新方法可以成功地发展成一种临床上相关的、商业上可行的下肢假体对齐系统。 COMPAS将是一个易于使用、修复师直观的集成系统。它的价格将是合理的，我们将为它的使用寻求一个报销代码，这样系统就可以自己支付费用。它将在不需要假肢医生特殊调节的情况下在下肢假体中得到几乎普遍的应用，并可在静态和动态情况下使用。患者将不受束缚，该系统将在正常的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示器，向假肢医生指示如何改善假体的对准。 第一阶段的工作将集中于构建原型硬件和软件，并演示我们方法的有效性。第二阶段将完善物理包装和临床能力，并将对该系统进行更广泛的科学验证。 第一阶段工作将由以下四个具体目标组成： 1.设计和制作原型Compas，2.改进对齐检测算法，3.利用概念验证Compas原型进行假体对齐测试，4.临床综述。 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，第一阶段项目的重点是演示启发式方法的概念证明，以完善一种算法，从力和力矩数据中识别行走过程中假肢插座底部收集的错位。临床假肢医生和其他假体步态专家的第一阶段反馈也将用于指导第二阶段的开发。 第二阶段工作将包括以下5个具体目标： 1.设计和构建最终的COMPAS硬件，2.设计COMPAS软件界面，3.改进比对检测算法，4.系统测试，5.提出最佳比对准则。 Cyma拥有一支出色的团队，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业务技能。

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.