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）：中风后治疗性运动的最重要目标之一是保持强度和耐力的肌肉，并有助于恢复受影响的四肢的功能使用。可以解决这些目标的一种相对较新的设备是Nustep TRS4000卧式交叉训练师，该培训师提供了一个耦合的互惠腿/手臂扩展运动运动，以防止分级负载，而受试者则保持安全和舒适性。我们建议使用功能性电刺激（FES）增强TRS4000，该功能有可能产生所需的相互阶梯模式，从而锻炼下肢肌肉组织，提供心肺运动机会，并提供脊髓和大脑，并为有针对性的传入反馈提供可能有助于恢复受启用的limb的功能的有针对性的传入。我们假设FES组件可以提高TRS4000练习的功效和可用性，从而为大量的潜在用户提高功效。我们预计成功实施将导致可行的商业产品，这将满足临床相关的需求，并在现有的Nustep设备的临床接受下建立。该阶段I项目的目标是：1）修改和仪器将TRS4000设备用于接口到专有的2通道自适应刺激器； 2）开发特异性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）通过一项试点研究证明该方法的可行性，该研究将在辛辛那提大学的神经运动恢复和康复实验室在Drake Rehabilitation Center（Cincinnnati，OH）的指导下在Stephen Page的指导下进行。可行性研究将包括招募三（3）名经历中风的受试者，这些受试者将分别参加3次参加FES的Nustep练习。将进行课程，并不断受到运动生理学家的监测以确保其安全性。可行性将定义为自适应刺激器开发特定于客户的刺激模式的能力，以在没有治疗师或研究工程师干预的情况下引起跨受试者和访问的拟议卧式垫脚运动。第二阶段的工作可能包括刺激器的修改，以简化仪器并刺激大量肌肉，对TRS4000的机械修饰，以提高运动恢复功能的功效，以及对足够样本量的临床试验，以证明具有FES启用的TRS4000的功效，以进行运动重新补习的潜力。该设备的目标市场将是康复诊所，在中风后为个人提供护理。 CustomKynetics，Inc。将寻求与Nustep，Inc。的战略联盟合作伙伴关系，用于制造，市场营销，销售和分销FES augmented TRS4000，目的是达到5000美元的价格。 /相关性刺激增强了中风康复申请人机构：CustomKynetics，Inc。（PI：Hartman，Eric C. Hartman C.），拟议的工作可能会通过开发电气刺激增强的卧式踩踏机（TRS4000，NUSTEP，INC。）均施加了锻炼和运动责任（7,000年）（7000，000年）（7000,000）（7000,000）（7000,000）。与独立的NUSTEP设备相比，电刺激组件可能会提高练习的功效，以使具有边际自愿控制的用户可以提高意志控制不足以否则参与的个人的练习可用性。