Adaptive Control of Flexion Withdrawal Reflex Stimulator for Locomotor Rehabilita

描述（由申请人提供）：恢复独立运动是不完全性脊髓损伤（iSCI）后最重要的治疗目标之一，可能会显著改善受影响个体的生活质量，并为受影响个体和医疗保健系统节省大量成本。来自不同研究小组的几项研究表明，功能性电刺激（FES）与体重支持的步态训练相结合，是一种安全有效的再训练神经回路以改善运动的方法。FES可用于直接刺激胫骨前部以辅助足下垂或引起屈曲退缩反射（FWR），导致髋/膝关节屈曲和踝关节背屈。FES是一种常用的足部跌落治疗方法，目前已有几种商业化产品。FWR技术对iSCI后个体康复的疗效已得到证实。虽然FWR在运动再训练中具有一些临床显著的优势，但该技术尚未得到广泛的临床接受。我们认为，FWR将在步态康复中得到更广泛的应用：1)如果有一个低成本、实用、全面的系统来实施该技术，2)如果该系统包含一个FES单元，该单元可以自动控制刺激强度和时间，这样治疗师就不必为客户定制适合的刺激或调整刺激模式来保持表现。我们提出了GaitSTIM”，一种用于fes增强步行治疗的新型康复系统。FES将采用自动、自适应刺激控制和完全集成的传感技术，提供脚踏和FWR操作模式。该系统还将提供听觉/视觉提示，以吸引客户参与治疗，并为临床医生提供基于表现的报告，这可能有助于处方，并提供必要的文件，以证明额外的治疗疗程是合理的。第一阶段SBIR项目的目标是证明我们基于传感器的概念自适应刺激方法控制FWR响应的可行性。我们将：1)开发和制造一个概念验证传感系统，以测试FWR运行模式；2)开发自适应刺激控制算法，根据传感器的测量结果调制FWR刺激；3)在可行性研究中验证基于传感器的自适应刺激控制概念，在可行性研究中，iSCI患者进行地上行走，期间FWR由研究设备或手动控制的实验室刺激器引发。第一阶段的可行性研究将在Edelle Field-Fote， PT， PhD的指导下与迈阿密麻痹治疗项目（迈阿密，佛罗里达州）合作进行。该设备的目标市场是为iSCI损伤或中风后接受康复治疗的患者提供服务的诊所。该系统的目标价格将是4000美元。公共卫生相关性：通过开发一种临床可行的、基于电刺激的康复装置，用于脊髓损伤或中风后的运动训练，拟议的工作可能有益于公共卫生。与现有的设备和技术相比，自适应控制的电刺激组件以及仪器、控制、刺激、可视化和报告功能的紧密集成可以提高许多受影响个体的治疗干预的有效性和可用性。

DESCRIPTION (provided by applicant): Recovery of independent locomotion is among the most significant therapeutic aims following incomplete spinal cord injury (iSCI) and may lead to dramatic improvements in quality of life for the affected individual as well as dramatic cost savings to both the affected individual and to the health care system. Several studies from various research groups have shown that functional electrical stimulation (FES) used in conjunction with bodyweight supported gait training is a safe and effective method for retraining the neural circuits to improve locomotion. FES may be used to either directly stimulate the tibialias anterior to assist with foot-drop OR to elicit the flexion withdrawal reflex (FWR) resulting in hip/knee flexion and ankle dorsiflexion. FES for foot drop is commonly used and several commercial products have resulted. Efficacy of the FWR technique has been demonstrated for individuals undergoing rehabilitation following iSCI. While FWR offers several clinically significant advantages in locomotor retraining, widespread clinical acceptance of the technique has not been achieved. We assert that FWR would be more widely practiced in gait rehabilitation: 1) if a low cost, practical, comprehensive system were available to implement the technique, and 2) if the system involved an FES unit that automatically controlled stimulation intensity and timing such that the therapist did not have to custom fit the stimulation to the client or adjust the stimulation pattern to maintain performance. We propose GaitSTIM", a novel rehabilitation system indicated for FES-augmented walking therapy. Offering foot-drop and FWR operating modes, FES will be delivered by a device with autonomous, adaptive stimulation control and completely integrated sensing technologies. The system will additionally offer audible/visual cues to engage the client in the therapy and performance-based reports for clinicians, which may assist in prescription and provide the documentation necessary to justify additional therapeutic sessions. The goals of this Phase I SBIR project are to demonstrate feasibility of our concept sensor-based adaptive stimulation approach for control of the FWR response. We will: 1) develop and fabricate a proof-of-concept sensing system to test the FWR operating mode; 2) develop adaptive stimulation control algorithms to modulate the FWR stimulus based on measurements from our sensors; and 3) validate the sensor-based adaptive stimulation control concept in a feasibility study in which individuals with iSCI perform overground walking during which FWR is elicited by either the investigational device or a manually controlled laboratory stimulator. The Phase I feasibility study will be conducted in collaboration with the Miami Project to Cure Paralysis (Miami, FL) under the direction of Edelle Field-Fote, PT, PhD. The target markets for this device would be clinics who serve patients undergoing rehabilitation following iSCI injury or stroke. The target price for the system will be $4000. PUBLIC HEALTH RELEVANCE: The proposed work may benefit public health through development of a clinically viable, electrical stimulation based rehabilitation device for use in locomotor training following spinal cord injury or stroke. Compared to existing devices and techniques, the adaptively controlled electrical stimulation component and tight integration of instrumentation, control, stimulation, visualization, and reporting features may improve efficacy and availability of the therapeutic intervention for many affected individuals.