Stimulation Augmented Recumbent Stepper for Stroke Rehabilitation

用于中风康复的刺激增强卧式踏步机

• 批准号: 7218851
• 负责人: Eric C Hartman
• 金额: $ 13.04万
• 依托单位: CUSTOMKYNETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-06 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7218851
• 关键词: Address; Affect; Algorithms; Bilateral; Biomechanics; Brain; Caring; Client; Clinic; Clinical; Clinical Trials; Computer Simulation; Coupled; Development; Devices; Doctor of Philosophy; Education; Electric Stimulation; Engineering; Exercise; Feasibility Studies; Feedback; Goals; Government; Individual; Institution; Intervention; Intervention Studies; Laboratories; Lead; Leg; Limb structure; Lower Extremity; Marketing; Mechanics; Modification; Monitor; Motor; Movement; Muscle; Numbers; Outcome; Patients; Pattern; Phase; Pilot Projects; Price; Public Health; Recovery; Recruitment Activity; Rehabilitation Centers; Rehabilitation therapy; Research; Safety; Sales; Sample Size; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Spinal Cord; Spinal cord injury; Stroke; Surface; Survivors; Technology; Therapeutic; Training; Universities; Upper arm; Visit; Work; base; chronic stroke; clinically relevant; concept; day; design; desire; experience; functional restoration; improved; instrument; instrumentation; motor control; post stroke; prototype; research study; restoration; simulation; stroke rehabilitation

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.

描述（由申请人提供）：卒中后治疗性运动的最重要目标之一是维持麻痹肌肉的力量和耐力，并帮助恢复受影响肢体的功能性使用。一个相对较新的和有前途的设备，可以解决这些目标是NuStep TRS 4000横卧交叉训练器，它提供了一个耦合的往复腿/手臂伸展运动对分级负荷，而受试者保持坐在安全和舒适。我们建议使用功能性电刺激（FES）增强TRS 4000，其有可能产生所需的往复步进模式，从而锻炼下肢肌肉组织，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，有助于恢复受影响肢体的功能。我们假设，FES组件可能会提高TRS 4000运动的有效性和可用性的显着比例的潜在用户。我们预计，成功实施将导致一个可行的商业产品，这将满足临床相关的需求，并建立在现有的NuStep设备的临床接受。该I期项目的目标是：1）修改和仪器化TRS 4000器械，用于连接专有的2通道自适应刺激器; 2）开发NuStep特定的自适应刺激控制算法; 3）通过模拟研究验证控制器设计;和4）通过将在辛辛那提大学神经运动康复中心进行的试点研究来证明这种方法的可行性，康复实验室在德雷克康复中心（辛辛那提，俄亥俄州）的指导下，斯蒂芬页，博士。可行性研究将包括招募3例发生卒中的受试者，他们将分别参加3次FES增强的NuStep运动。训练将由运动生理学家进行管理，并对患者进行持续监测，以确保他们的安全。可行性将定义为自适应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，在受试者和访视期间引起拟定的卧位步进运动。第二阶段的工作可能包括刺激器修改，以简化仪器和刺激更多的肌肉，对TRS 4000进行机械修改，以提高运动再教育应用的有效性，以及足够样本量的临床试验，以证明FES使能的TRS 4000在运动中的有效性，并有可能改善运动再教育。该设备的目标市场将是为中风后的个人提供护理的康复诊所。customKYnetics，Inc.将寻求与NuStep，Inc.建立战略联盟伙伴关系。用于制造、营销、销售和分销FES增强的TRS 4000，目标是实现5000美元的价格点。/ Relevance脑卒中康复用刺激增强卧位踏步机申请单位：customKYnetics，Inc. (PI作者：Hartman，Eric C.）拟议的工作可能有利于公共健康，通过开发电刺激增强横卧踏步机（TRS 4000，NuStep，Inc.）适用于中风（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，电刺激部件可以提高具有边际意志控制的用户的锻炼的功效，并且可以提高意志控制不足的个体参与锻炼的可用性。