FastFES Neural Prothesis for Stroke Ambulation and Rehabilitation

描述(由申请人提供)：这项FastTrack SBIR提案旨在传播用于中风步行和神经运动康复的功能性电刺激(FES)技术。FastFES范例集成了两种康复方法，快节奏跑步机步行和FES，已被证明既可以在刺激活跃时改善步态运动学，也可以通过长期干预改善临床任务中的表现。精确计时的FES模式提供：1)在步态的终末双站立阶段提供足屈(PF)辅助效应；2)在摆动阶段提供背屈(DF)辅助效应。与商业上可用的纯DF系统相比，FastFES设备将在PF刺激模式的结果下，在发射过程中提供更好的偏瘫腿部地面反作用力。这将推动瘫痪的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。这项技术是在特拉华大学的斯图亚特·宾德-麦克劳德博士的实验室里开发的。FastFES系统将包括一个腿部穿戴的刺激器，该刺激器无线连接到仪表式脚踏开关系统。仪器将提供强大和可靠的步态周期测量，以促进复杂的FES模式与客户的自愿步态的协调。临床医生配置挂件将允许临床医生对该设备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患者的有效性。第一阶段项目将通过展示CustomKYnetics的刺激器可以实施FastFES的可变频率序列(VFT)刺激模式来证明概念的可行性，从而使人类骨骼肌的收缩具有与实验室刺激器产生的收缩相当的质量。第二阶段项目将涉及开发商业化准备系统的重大工程努力，并将包括UD的一项验证研究，在该研究中，中风后继发性瘫痪的患者反复评估设备原型。疗效将通过一项长期、单盲、随机、对照的临床干预研究来证明。结果将包括对患者步态模式的运动学评估(有无STIM)和对临床功能变化的评估。该设备的目标市场将是服务于中风市场的康复诊所。该设备还将适用于家庭/社区使用。该产品将提供与该领域现有产品的明显区别。临床系统的目标价格将是5,000美元。临床系统的潜在市场估计为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用于中风后步行和神经运动康复的功能性电刺激系统而有益于健康(每年795,000例)。由于FastFES系统在行走过程中采用了足屈和背屈刺激的新组合，因此可以提供更好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.