Stimulation Augmented Recumbent Stepper for Stroke Rehabilitation

描述(申请人提供)：中风后治疗练习的最重要目标之一是保持瘫痪肌肉的力量和耐力，并帮助恢复受影响肢体的功能使用。一个相对较新且前景看好的设备是NuStep TRS4000卧式交叉训练器，它提供针对分级负荷的双向腿部/手臂伸展运动，同时受试者保持坐着以确保安全和舒适。我们建议用功能性电刺激(FES)来增强TRS4000，它有可能产生所需的相互步进模式，从而锻炼腿部肌肉，提供心肺锻炼的机会，并为脊髓和大脑提供定向的传入反馈，可能有助于受影响肢体的功能恢复。我们假设，对于相当大比例的潜在用户，FES组件可能会改善TRS4000锻炼的有效性和可用性。我们预计，成功的实施将带来可行的商业产品，它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。该第一阶段项目的目标是：1)修改TRS4000设备并安装仪器，以连接专有的2通道自适应刺激器；2)开发特定于NuStep的自适应刺激控制算法；3)通过模拟研究验证控制器设计；4)在辛辛那提大学德雷克康复中心(辛辛那提，俄亥俄州)，在Stephen Page博士的指导下进行一项初步研究，以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增强的NuStep练习。会议将由运动生理学家管理，患者将持续监测，以确保他们的安全。可行性将被定义为适应性刺激器开发特定于客户的刺激模式的能力，以在不需要治疗师或研究工程师干预的情况下，在受试者和访客之间引发拟议的卧式踏步运动。第二阶段的工作可能包括改装刺激器以简化器械和刺激更多的肌肉，对TRS4000进行机械改装以提高运动再教育应用的有效性，以及进行足够样本量的临床试验，以证明启用FES的TRS4000用于锻炼的有效性和改善运动再教育的潜力。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公司就FES增强的TRS4000的制造、营销、销售和分销建立战略联盟伙伴关系，目标是实现5000美元的价位。中风康复申请机构：CustomKYnetics，Inc.(PI：Hartman，Eric C.)拟议的工作可能会通过开发一种电刺激增强型卧式步进机(TRS4000，NuStep，Inc.)来造福公众健康。用于中风(每年700,000例)或脊髓损伤(每年11,000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具有边缘意志控制的用户的锻炼的有效性，并且可以提高意志控制不足的个人以其他方式参与的锻炼的可用性。

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.