Development of a Low Cost, Real-time Biofeedback Gait Retraining System

描述（由申请人提供）：该SBIR项目旨在将非常有效的实时步态生物反馈技术迁移到康复诊所，医院和其他处理损伤或损伤的组织中。实时步态生物反馈长期以来已成功地用于损伤的康复，用于校正与损伤相关的步态模式，并且可能更重要的是，用于校正与诸如骨关节炎的损伤风险相关的步态模式。这种系统的潜力实际上是无限的，因为它们是非侵入性的，并且可以基于大量的客观测量和性能指标。然而，这种系统在日常临床实践中的使用目前受到限制，部分原因是具有由受过高度训练的操作员管理的专用实验室空间的3D运动捕捉系统的成本超过10万美元，以及缺乏标准化的培训/再培训协议。我们建议克服这些障碍，生产低成本，操作简单的实时生物反馈步态再训练系统，可以修改工作与多个临床协议。该产品将是一个用于步态（步行和跑步）再训练的商业系统，包括跑步机，流式3D运动捕捉和生物力学分析，以及不到1.5万美元的视频反馈显示器，预计技术的进步（例如使用低成本加速度计的混合系统）甚至可能降低这一成本。关键是利用新一代低成本3D运动捕捉设备，以及C-Motion可以基于我们的高端Visual3D生物力学研究工具开发的一套既定协议和新软件系统。视觉反馈（实时图形，仪表和其他显示）将通过创建一个名为Feedback3D的新产品，利用C-Motion的Visual3D库从定制软件中生成。Feedback3D最初将与一个低成本的基于光学的3D运动捕捉系统集成，该系统使用NaturalPoint Optitrack Flex：V100R2相机、ADtech的AMASS校准和3D重建软件。通过对真实的世界中的临床医生的调查和访谈、客户对这种产品的要求，结合研究人员、临床医生和现有运动捕捉用户的经验和观察，已经验证了对这种系统的真实的需求。在第一阶段，我们将开发一个Feedback3D的原型版本，这将为第二阶段项目奠定基础，通过证明一个更便宜的生物反馈系统产生类似的效果，高端实验室系统。更重要的是，通过与Bader Consortium（见支持函）合作，我们将通过建立标准化方案的创建和记录流程来解决上述其他障碍，使其成为实用的临床工具。 公共卫生相关性：几十年来，通过实时运动捕获反馈的步态保持已成功用于修改与步行和跑步步态相关的损伤或矫形问题相关的步态模式。通过在康复过程的早期解决潜在的机械问题，它改善了结果，有助于减少损伤的复发，以及异常力学（如骨关节炎）的长期后果，并可以减少甚至消除疼痛。要解决的问题是，提供这种类型的再训练的系统极其昂贵、复杂，它们需要大型设施和训练有素的操作者，并且以科学的方式提供结果，这对于忙碌的临床医生来说是难以解释的。该SBIR项目（第1和第2阶段）旨在通过生产低成本、操作简单的实时生物反馈步态再训练系统来克服这些当前实际实时生物反馈系统的障碍。该系统是模块化的，可以快速适应多种临床协议，从而针对广泛的患者群体。由于步态再训练的补偿已经在现有的CPT代码中涵盖，因此低成本的生物反馈再训练系统应该在经济上自给自足，并最终通过将标准化，客观和基于研究的生物反馈训练带到日常临床环境中来使拟议的系统产生巨大的广泛影响。第一阶段旨在验证低成本系统的有效性及其 以快速和有用的方式捕获有意义的数据。它还将产生一个原型实时生物反馈软件包，可以发展成一个商业应用。第2阶段项目将利用原型工具来定义流程、标准和初始临床方案，并提供反馈显示和必要的生物力学参数，以解决与损伤或损伤相关的纠正步态模式。

DESCRIPTION (provided by applicant): This SBIR project is designed to enable the migration of very effective real-time gait biofeedback technology into rehabilitation clinics, hospitals, and other organizations working with impairments or injury. Real-time gait biofeedback has long been used successfully for rehabilitation of injury, for correcting gait patterns associated with impairment, and perhaps more importantly, for correcting gait patterns associated with the risk of impairments such as osteoarthritis. The potential of such systems is virtually limitless because they are non- invasive and can be based on a vast array of objective measurements and performance indices. The usage of such systems in everyday clinical practice is currently limited, however, in part by costs in excess of $100K for a 3D motion capture system with dedicated laboratory space managed by a highly trained operator, and the lack of standardized training/retraining protocols. We propose overcoming these barriers by producing a low cost, straightforward to operate real-time biofeedback gait retraining system that can be modified to work with multiple clinical protocols. The product will be a commercial system for gait (walking and running) retraining, consisting of a treadmill, streaming 3D Motion Capture and biomechanical analyses, and a video feedback display for less than $15K, and anticipated advances in technology (such as hybrid systems using low-cost accelerometers) may even reduce this cost. The key is in leveraging a new generation of low cost 3D motion capture equipment with an established set of protocols and a new software system that C-Motion can develop based on our high end Visual3D biomechanics research tools. Visual feedback (real-time graphs, gauges, and other displays) will be generated from custom software leveraging C-Motion's Visual3D libraries by creating a new product called Feedback3D. Feedback3D will initially be integrated with a low-cost optically based 3D Motion Capture system using NaturalPoint Optitrack Flex:V100R2 cameras, ADtech's AMASS calibration and 3D reconstruction software. The real need for such a system has been validated through surveys and interviews with clinicians in the real world, customer requests for such a product, combined with the experience and observations of researchers, clinicians, and existing motion capture users. In Phase I we will develop a prototype version of Feedback3D that will lay the groundwork for a Phase II project by demonstrating that a less expensive biofeedback system yields similar effectiveness to high end laboratory systems. More importantly, in collaboration with the Bader Consortium (see letter of support) we will address the other barriers listed above by establishing a process for the creation and documentation of standardized protocols that will make this a practical clinical tool. PUBLIC HEALTH RELEVANCE: Gait Retaining via real-time motion capture feedback has been used successfully for many decades to modify gait patterns that have been associated with injuries or orthopedic issues related to walking and running gait. By addressing underlying mechanical problems early in the rehabilitation process it improves outcomes, helps reduce the recurrence of injury, as well as the long term consequences of the abnormal mechanics, such as osteoarthritis, and can reduce or even eliminate pain. The problem to resolve is that systems to provide this type of retraining are extremely expensive, complicated, they require large facilities and highly trained operators, and provide results in a scientific manner that is difficut for a busy clinician to interpret. This SBIR project (Phase 1 and 2) is designed to overcome these current barriers to practical real-time biofeedback systems by producing a low cost, straightforward to operate real-time biofeedback gait retraining system. The system is modular and can be adapted quickly to multiple clinical protocols and thus target a wide range of patient populations. Since reimbursement for gait retraining already is covered under existing CPT codes, a low cost biofeedback retraining system should be financially self-sufficient and will ultimately allow the proposed system to have tremendous broad impact by bringing standardized, objective, and research-based biofeedback training to the everyday clinical setting. Phase 1 is designed to validate the effectiveness of low-cost systems and their ability to capture meaningful data in a quick and useful manner. It also will result in a prototype real-time biofeedback software package that can evolve into a commercial application. The Phase 2 project will be to leverage the prototype tools to define the processes, standards, and initial clinical protocols, with feedback displays and the biomechanical parameters necessary to address correcting gait patterns associated with impairments or injuries.