FastFES Neural Prothesis for Stroke Ambulation and Rehabilitation

描述（由申请人提供）：本FastTrack SBIR提案旨在传播用于卒中缓解和神经运动康复的功能性电刺激（FES）技术。FastFES范式整合了两种康复方法，即快节奏跑步机行走和FES，其方式已被证明在刺激活跃时可改善步态运动学，并通过长期干预改善临床任务的表现。精确定时的FES模式提供：1）在步态的终端双站立阶段期间的跖屈（PF）辅助效果;以及2）在摆动阶段期间的背屈（DF）辅助效果。与市售仅DF系统相比，FastFES器械将在蹬离期间提供改善的麻痹腿地面反作用力，这是PF刺激模式的结果。这将用于推动麻痹腿通过步态周期的摆动阶段，从而提供更正常的步态运动学。这项技术是由特拉华州大学的Stuart Binder-Macleod博士的实验室开发的。FastFES系统将包括一个腿戴式刺激器，该刺激器无线耦合到仪表脚踏开关系统。仪器将提供稳健和可靠的步态周期测量，以促进复杂的FES模式与客户的意志步态的协调。临床医生配置挂件将允许临床医生对器械的高级功能进行编程，并在临床环境中管理多个用户。该设备还将记录步态周期数据，以总结其使用情况，并帮助临床医生评估该设备对特定客户的有效性。第一阶段项目将通过证明customKYnetics的刺激器可以实现FastFES的可变频率序列（VFT）刺激模式来证明概念的可行性，从而使人体骨骼肌的收缩质量与实验室刺激器产生的收缩质量相当。第二阶段项目将涉及大量的工程工作，以开发商业化就绪系统，并将包括在UD进行的确认研究，其中继发于中风的轻瘫患者迭代评估器械原型。将通过长期、单盲、随机、对照临床干预研究证明疗效。结果将包括客户步态模式的运动学评估（有和没有刺激）和临床功能变化的评估。该设备的目标市场将是为中风市场服务的康复诊所。该设备也将适合家庭/社区使用。该产品将与该领域现有产品有明显的差异化。临床系统的目标价格为5000美元。据估计，临床系统的可寻址市场为10，000台，家用系统至少为500，000台。 公共卫生相关性：拟议的工作可能会通过开发一种功能性电刺激系统来有益于健康，该系统适用于中风后的截肢和神经运动康复（每年795，000例）。由于步行期间跖屈和背屈刺激的新颖组合，拟议的FastFES系统可以提供改善的腿部地面反作用力并提供更正常的步态运动学。

DESCRIPTION (provided by applicant): This FastTrack SBIR proposal aims to disseminate a Functional Electrical Stimulation (FES) technology for stroke ambulation and neuromotor rehabilitation. The FastFES paradigm integrates two rehabilitation approaches, fast-paced treadmill walking and FES, in a manner that has been shown to both improve gait kinematics when the stimulation is active and to improve performance in clinical tasks with long-term intervention. Precisely timed FES patterns provide: 1) a plantarflexion (PF) assist effect during the terminal double-stance phase of gait; and 2) a dorsiflexion (DF) assist effect during the swing phase. Compared to commercially available DF-only systems, the FastFES device will provide improved paretic leg ground reaction forces during push-off as a result of the PF stimulation pattern. This will act to propel the paretic leg through the swing phase of the gait cycle and thus provide more normal gait kinematics. The technology has been developed at the University of Delaware in the laboratory of Dr. Stuart Binder-Macleod, PT, PhD. The FastFES system will include a leg-worn stimulator that is wirelessly coupled to an instrumented footswitch system. Instrumentation will provide robust and reliable gait cycle measurements to facilitate coordination of the complex FES patterns to the client's volitional gait. A clinician configuration pendant will allow clinicians to program advanced features of the device and to manage multiple users in a clinical environment. The device will also record gait cycle data to summarize its use and to aid the clinician in assessing the device's effectiveness for a particular client. The Phase I project will prove concept feasibility by demonstrating that customKYnetics' stimulator can implement the FastFES's variable frequency train (VFT) stimulation pattern such that contractions of human skeletal muscle are of comparable quality to those produced by the laboratory stimulator. The Phase II project will involve significant engineering efforts to develop the commercialization-ready system and will include a validation study at UD in which individuals with paresis secondary to a stroke iteratively evaluate device prototypes. Efficacy will be demonstrated through a long-term, single-blinded, randomized, controlled clinical intervention study. Outcomes will include kinematic assessment of the client's gait pattern (with and without stim) and assessments of changes in clinical function. The target market for the device will be rehabilitation clinics that serve the stroke market. The device will also be suitable for home/community-use. The product will provide clear differentiation over existing products in the space. The target price for a clinical system will be $5,000. The addressable market is estimated at 10,000 units for a clinical system and at least 500,000 units for a home system. PUBLIC HEALTH RELEVANCE: The proposed work may benefit health through development of a functional electrical stimulation system indicated for ambulation and neuromotor rehabilitation following stroke (795,000 cases per year). Due to the novel combination of plantarflexion and dorsiflexion stimulation during ambulation, the proposed FastFES system may provide improved leg ground reaction forces and provide more normal gait kinematics.