Stimulation Augmented Recumbent Stepper for Stroke Rehabilitation

描述（由申请人提供）：中风后治疗性运动的最重要目标之一是保持麻痹性肌肉的力量和耐力，并帮助恢复受影响肢体的功能使用。NuStep TRS4000卧式交叉训练器是一种相对较新的、有前景的设备，它可以解决这些问题，它可以在受试者保持坐姿的同时，针对不同的负荷提供耦合的腿部/手臂伸展锻炼运动，以保证安全性和舒适性。我们建议通过功能性电刺激（FES）来增强TRS4000，这有可能产生所需的反向步进模式，从而锻炼下肢肌肉，提供心肺运动机会，并为脊髓和大脑提供有针对性的传入反馈，这可能有助于恢复受影响肢体的功能。我们假设FES组件可以提高TRS4000锻炼的有效性和可用性，对于很大比例的潜在用户。我们预计成功实施将导致可行的商业产品，这将满足临床相关需求，并建立在现有临床接受NuStep设备的基础上。这个第一阶段项目的目标是：1)修改和测量TRS4000设备的接口，用于专有的2通道自适应刺激器；2)开发针对nustep的自适应刺激控制算法；3)通过仿真研究验证控制器设计；4)在Stephen Page博士的指导下，通过在Drake康复中心（Cincinnati， OH）的辛辛那提大学神经运动恢复和康复实验室进行的一项试点研究来证明该方法的可行性。可行性研究将包括招募三(3)名经历过中风的受试者，他们每人将参加3次fes增强NuStep锻炼。运动生理学家将对训练过程进行管理，并对患者进行持续监测，以确保他们的安全。可行性将被定义为适应性刺激器开发客户特定刺激模式的能力，以在没有治疗师或研究工程师干预的情况下，在受试者和访问中引出所建议的平躺行走运动。第二阶段的工作可能包括对刺激器进行修改，以简化仪器和刺激更多的肌肉，对TRS4000进行机械修改以提高运动再教育应用的功效，并进行足够样本量的临床试验，以证明FES-enabled TRS4000在运动中的功效，并有可能改善运动再教育。该设备的目标市场将是为中风患者提供护理的康复诊所。customKYnetics公司将寻求与NuStep公司建立战略联盟伙伴关系，共同制造、营销、销售和分销fes增强型TRS4000，目标是实现5000美元的价格点。申请机构：customkytics， Inc. （PI: Hartman, Eric C.）拟议的工作可能通过开发电刺激增强卧式踏步机（TRS4000, NuStep, Inc.）有益于公众健康，用于中风（每年70万例）或脊髓损伤（每年1.1万例）后的运动和运动再教育。与独立的NuStep设备相比，电刺激组件可以提高意志控制有限的用户的锻炼效果，也可以提高意志控制不足而无法参与锻炼的个人的锻炼有效性。

DESCRIPTION (provided by applicant): Among the most significant goals of therapeutic exercise following stroke are maintaining strength and endurance of paretic muscles and aiding in restoration of functional use of the affected limbs. One relatively new and promising device that may address these aims is the NuStep TRS4000 recumbent cross trainer, which provides a coupled reciprocal leg/arm extension exercise movement against graded loads while the subject remains seated for safety and comfort. We propose to augment the TRS4000 with functional electrical stimulation (FES), which has the potential to produce the required reciprocal stepping pattern thereby exercising the lower extremity musculature, providing a cardiorespiratory exercise opportunity, and providing the spinal cord and brain with targeted afferent feedback that may aid in restoration of function of the affected limbs. We hypothesize that the FES component may improve both efficacy and availability of TRS4000 exercise for a significant percentage of potential users. We anticipate that successful implementation would lead to a viable commercial product, which would meet a clinically relevant need and build upon existing clinical acceptance of the NuStep device. The goals of this Phase I project are: 1) to modify and instrument a TRS4000 device for interface to a proprietary 2-channel adaptive stimulator; 2) to develop NuStep-specific adaptive stimulation control algorithms; 3) to validate controller design through simulation studies; and 4) to demonstrate feasibility of the approach through a pilot study that will be performed at the University of Cincinnati's Neuromotor Recovery and Rehabilitation Laboratory at Drake Rehabilitation Center (Cincinnati, OH) under the direction of Stephen Page, PhD. The feasibility study will include recruitment of three (3) subjects that have experienced a stroke who will each participate in 3 sessions of FES-augmented NuStep exercise. Sessions will be managed and patients continually monitored by an Exercise Physiologist to assure their safety. Feasibility will be defined as the ability for the adaptive stimulator to develop client-specific stimulation patterns to elicit the proposed recumbent stepping movement across subjects and visits without intervention of therapists or research engineers. Phase II work may include stimulator modifications to simplify instrumentation and to stimulate a larger number of muscles, mechanical modifications to the TRS4000 to improve efficacy in motor reeducation applications, and a clinical trial of sufficient sample size to demonstrate efficacy of the FES-enabled TRS4000 for exercise with the potential for motor re-education improvements. The target market for the device will be rehabilitation clinics that provide care to individuals following stroke. customKYnetics, Inc. will seek a Strategic Alliance partnership with NuStep, Inc. for manufacturing, marketing, sales, and distribution of the FES-augmented TRS4000 with the goal of achieving a price point of $5000. / Relevance Stimulation Augmented Recumbent Stepper for Stroke Rehabilitation Applicant Institution: customKYnetics, Inc. (PI: Hartman, Eric C.) The proposed work may benefit public health through development of an electrical stimulation augmented recumbent stepping machine (TRS4000, NuStep, Inc.) indicated for exercise and motor reeducation following stroke (700,000 cases per year) or spinal cord injury (11,000 cases per year). Compared to the stand-alone NuStep device, the electrical stimulation component may improve efficacy of the exercise for users with marginal volitional control and may improve availability of the exercise for individuals with insufficient volitional control to otherwise participate.