FastFES Neural Prothesis for Stroke Ambulation and Rehabilitation

用于中风行走和康复的 FastFES 神经假体

• 批准号: 8060060
• 负责人: Eric C Hartman
• 金额: $ 12.6万
• 依托单位: CUSTOMKYNETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8060060
• 关键词: Award; Biomechanics; Blinded; Client; Clinic; Clinical; Communities; Complex; Coupled; Data; Delaware; Development; Devices; Doctor of Philosophy; Effectiveness; Electric Stimulation; Engineering; Environment; Frequencies; Gait; Health Benefit; Home environment; Human; Individual; Intervention; Intervention Studies; Knee; Laboratories; Leg; Marketing; Measurement; Measures; Muscle; National Institute of Nursing Research; Outcome; Paresis; Pattern; Performance; Phase; Poaceae; Positioning Attribute; Price; Randomized; Reaction; Rehabilitation therapy; Research Infrastructure; Secondary to; Shoes; Skeletal Muscle; Small Business Innovation Research Grant; Stroke; System; Technology; Time; TimeLine; Training; Universities; Walking; Work; base; commercialization; cost; design; hemiparesis; improved; instrument; instrumentation; kinematics; neural prosthesis; novel; programs; prototype; quadriceps muscle; relating to nervous system; stroke rehabilitation; validation studies; volunteer

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.

描述（由申请人提供）：该 FastTrack SBIR 提案旨在传播用于中风行走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，其方式已被证明既可以在刺激活跃时改善步态运动学，又可以通过长期干预提高临床任务的表现。精确定时的 FES 模式提供： 1) 在步态的双站立阶段末期提供跖屈 (PF) 辅助效果； 2) 摆动阶段的背屈 (DF) 辅助效果。与市售的仅 DF 系统相比，FastFES 设备将由于 PF 刺激模式而在推离期间提供改进的瘫痪腿部地面反作用力。这将推动瘫痪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。该技术是在特拉华大学 Stuart Binder-Macleod 博士（PT、PhD）实验室开发的。 FastFES 系统将包括一个腿戴式刺激器，该刺激器无线连接到仪表脚踏开关系统。仪器将提供强大而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设备的高级功能进行编程并管理临床环境中的多个用户。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 的变频训练 (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重大工程工作，以开发可商业化的系统，并将包括在 UD 进行的一项验证研究，其中中风继发性麻痹患者将迭代评估设备原型。有效性将通过长期、单盲、随机、对照临床干预研究来证明。结果将包括对客户步态模式（有或没有刺激）的运动学评估和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。该设备也适合家庭/社区使用。该产品将与该领域现有产品相比具有明显的差异化。临床系统的目标价格为 5,000 美元。临床系统的潜在市场估计为 10,000 台，家庭系统的潜在市场至少为 500,000 台。 公共健康相关性：拟议的工作可能通过开发用于中风后行走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）。由于步行过程中跖屈和背屈刺激的新颖组合，所提出的 FastFES 系统可以提供改进的腿部地面反作用力并提供更正常的步态运动学。