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

描述（由申请人提供）：这个SBIR项目旨在将非常有效的实时步态生物反馈技术移植到康复诊所、医院和其他处理损伤或受伤的组织中。实时步态生物反馈已经成功地用于损伤的康复，用于纠正与损伤相关的步态模式，也许更重要的是，用于纠正与骨关节炎等损伤风险相关的步态模式。这种系统的潜力几乎是无限的，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3D动作捕捉系统的成本超过10万美元，该系统需要由训练有素的操作员管理专用实验室空间，并且缺乏标准化的培训/再培训协议。我们建议通过生产一种低成本、操作简单的实时生物反馈步态再训练系统来克服这些障碍，该系统可以根据多种临床协议进行修改。该产品将是一个用于步态（步行和跑步）再训练的商业系统，由跑步机、流媒体3D运动捕捉和生物力学分析以及视频反馈显示器组成，价格不到1.5万美元，预计技术的进步（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的3D运动捕捉设备，建立一套协议和新的软件系统，C-Motion可以基于我们的高端Visual3D生物力学研究工具开发。视觉反馈（实时图形、仪表和其他显示）将通过创建名为feedback 3d的新产品，从利用C-Motion的Visual3D库的定制软件中生成。Feedback3D最初将集成低成本光学3D运动捕捉系统，该系统使用NaturalPoint Optitrack Flex:V100R2相机、ADtech的AMASS校准和3D重建软件。通过对现实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、临床医生和现有动作捕捉用户的经验和观察，验证了对这种系统的真正需求。在第一阶段，我们将开发一个反馈3d的原型版本，通过证明较便宜的生物反馈系统产生与高端实验室系统相似的效果，为第二阶段项目奠定基础。更重要的是，通过与Bader联盟的合作（见支持信），我们将通过建立标准化协议的创建和文档化流程来解决上面列出的其他障碍，使其成为实用的临床工具。

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.