Adaptive Control of Flexion Withdrawal Reflex Stimulator for Locomotor Rehabilita

用于运动康复的屈曲缩回反射刺激器的自适应控制

• 批准号: 7400171
• 负责人: Eric C Hartman
• 金额: $ 11.9万
• 依托单位: CUSTOMKYNETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-19 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7400171
• 关键词: Acceleration; Affect; Algorithms; Ankle; Anterior; Ants; Area; Articular Range of Motion; Back; Bilateral; Biomechanics; Client; Clinic; Clinical; Collaborations; Communication; Cost Savings; Cues; Custom; Data; Development; Devices; Doctor of Philosophy; Documentation; Drops; Electric Stimulation; Event; Exercise; Feasibility Studies; Floor; Foot-drop; Gait; Goals; Government; Healthcare Systems; Hip region structure; Imagery; Individual; Injury; Intervention; Joints; Knee; Laboratories; Laboratory Research; Lead; Learning; Left; Leg; Locomotion; Locomotor retraining; Manuals; Marketing; Measurement; Measures; Mechanics; Memory; Methods; Movement; Muscle; Nerve; Numbers; Orthotic Devices; Outcome; Output; Paralysed; Participant; Patients; Pattern; Performance; Phase; Pilot Projects; Price; Public Health; Quality of life; Randomized; Range; Range of motion exercise; Recovery; Reflex action; Rehabilitation Research; Rehabilitation device; Rehabilitation therapy; Reporting; Research; Research Design; Right-On; Sampling; Self-Help Devices; Side; Signal Transduction; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solutions; Speed; Spinal cord injury; Step training; Stimulus; Stroke; Structure; Subgroup; Support System; System; Techniques; Technology; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Visual; Walkers; Walking; Weight; Wireless Technology; Withdrawal; Work; ankle joint; auditory feedback; base; clinically relevant; clinically significant; concept; cost; design; electronic stimulator; foot; improved; instrumentation; neural circuit; novel; peroneal nerve; prescription document; prescription procedure; prototype; research and development; response; restoration; robot assistance; sensor; statistics; success; volunteer

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.

描述（由申请人提供）：独立运动的恢复是不完全性脊髓损伤（iSCI）后最重要的治疗目标之一，可显著改善受影响个体的生活质量，并显著节省受影响个体和医疗保健系统的成本。 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结合使用是一种安全有效的方法，用于重新训练神经回路以改善运动。 FES可用于直接刺激胫骨前肌以辅助足下垂，或引发屈曲撤回反射（FWR），从而导致髋关节/膝关节屈曲和踝关节背屈。 用于足下垂的FES是常用的，并且已经产生了几种商业产品。 FWR技术的有效性已被证明用于iSCI后接受康复治疗的个体。 虽然FWR在运动再训练方面提供了几个临床上显著的优势，但该技术尚未获得广泛的临床接受。 我们断言，FWR将在步态康复中得到更广泛的实践：1）如果低成本、实用、全面的系统可用于实施该技术，以及2）如果该系统涉及自动控制刺激强度和定时的FES单元，使得治疗师不必定制适合客户的刺激或调整刺激模式以保持性能。 我们提出了“GaitSTIM”，这是一种适用于FES增强步行治疗的新型康复系统。 FES提供足下垂和FWR操作模式，将通过具有自主、自适应刺激控制和完全集成的传感技术的设备提供。 该系统还将提供听觉/视觉提示，以使客户参与治疗，并为临床医生提供基于性能的报告，这可能有助于处方并提供证明额外治疗会话合理性所需的文档。 这个第一阶段SBIR项目的目标是证明我们的概念传感器为基础的自适应刺激方法的FWR响应控制的可行性。 我们将：1）开发和制造概念验证感测系统以测试FWR操作模式; 2）开发自适应刺激控制算法以基于来自我们的传感器的测量来调制FWR刺激;以及3）验证传感器-在一项可行性研究中，基于自适应刺激控制概念，iSCI患者进行地上行走，在此期间，通过研究器械或手动受控实验室刺激器。 I期可行性研究将在Edelle Field-Fote，PT，PhD的指导下与迈阿密瘫痪治疗项目（迈阿密，佛罗里达州）合作进行。 该器械的目标市场是为iSCI损伤或卒中后接受康复治疗的患者提供服务的诊所。 该系统的目标价格为4000美元。 公共卫生关系：拟议的工作可能有利于公众健康，通过开发一个临床上可行的，电刺激为基础的康复设备，用于运动训练脊髓损伤或中风。 与现有的设备和技术相比，自适应控制的电刺激部件和仪器、控制、刺激、可视化和报告特征的紧密集成可以提高治疗干预对于许多受影响个体的功效和可用性。