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）：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，可能会显着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。 多个研究小组的多项研究表明，功能性电刺激 (FES) 与体重支持步态训练结合使用是重新训练神经回路以改善运动的安全有效的方法。 FES 可用于直接刺激胫骨前肌以协助足下垂，或引发屈曲撤退反射 (FWR)，从而导致髋/膝关节屈曲和踝关节背屈。 FES 治疗足下垂很常用，并且已经产生了几种商业产品。 FWR 技术的有效性已在 iSCI 后接受康复治疗的个体中得到证实。 虽然 FWR 在运动再训练方面提供了一些临床上显着的优势，但该技术尚未获得广泛的临床认可。 我们断言，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、全面的系统可用于实施该技术，2）如果系统涉及自动控制刺激强度和时间的 FES 单元，这样治疗师就不必为客户定制刺激或调整刺激模式来保持表现。 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，将由具有自主、自适应刺激控制和完全集成传感技术的设备提供。该系统还将提供听觉/视觉提示，让客户参与治疗，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来证明额外的治疗是合理的。 治疗课程。 第一阶段 SBIR 项目的目标是证明我们基于传感器的自适应刺激概念方法控制 FWR 响应的可行性。 我们将： 1) 开发和制造概念验证传感系统来测试 FWR 操作模式； 2) 开发自适应刺激控制算法，根据传感器的测量结果来调节 FWR 刺激； 3）验证基于传感器的自适应刺激 可行性研究中的控制概念，其中 iSCI 患者进行地面行走，在此期间由研究设备或手动控制的实验室刺激器引发 FWR。 第一阶段可行性研究将在 Edelle Field-Fote 博士的指导下与迈阿密治愈瘫痪项目（佛罗里达州迈阿密）合作进行。 该设备的目标市场是为接受康复治疗的患者提供服务的诊所 iSCI 损伤或中风。 该系统的目标价格为 4000 美元。 公共健康相关性：拟议的工作可能通过开发一种临床上可行的、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而有益于公共健康。 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功效和 为许多受影响的个体提供治疗干预。