Untethered Home Therapy System

描述（由申请人提供）：目的是设计、构建和临床评估无栓系家庭治疗系统（UHTS）。所提出的系统应加快时间进程，并增加中风导致的上肢运动缺陷的功能恢复量。目前已经有了巨大的增长和积极的研究脑可塑性和运动再学习中风后。拟议的UHTS将提供一个基于家庭的系统，用于继续和监测治疗。允许患者在家中继续治疗，并灵活安排治疗时间，应可增加治疗时间，从而改善功能。此外，它还将为弱势群体提供更好的治疗机会。患者和/或其护理人员可轻松接受UHTS使用培训。拟议的UHTS将利用可穿戴传感和刺激技术自动调节功能性电刺激（FES）并改善治疗。UHTS将采用轻质、易于佩戴的袖套，嵌入干表面肌电图（EMG）电极、运动传感器、刺激器单元和无线电收发器。无栓系设计将提高患者安全性，并允许患者在不取出器械的情况下折断器械。肌电图和运动数据将从袖子传输到附近的笔记本电脑。动态临床电影将指导受试者治疗任务，包括各种简单和复杂的手臂运动、抓握力跟踪、EMG和/或位置跟踪以及抓握力任务。将在临床医生规定的特定时间段内重复每项任务。通过监测EMG和动力学信号，我们将区分治疗任务，监测依从时间，并提供反馈。此外，运动、协调模式和/或EMG将被用作算法的输入，该算法经过训练以向目标肌肉输出适当水平的FES，这将有助于治疗。换句话说，它将自动检测用户何时尝试执行他们无法自愿完成的治疗任务并协助FES。独特的软件界面将通过基于电影的指导，实时反馈和医生定义的治疗目标来鼓励患者。将计算与功能改善相关的定量指标，并在报告中提交给临床医生。报告将通过互联网从患者家中传输到医生办公室，以便在线监测和修改治疗。监测家庭治疗应该给医生一个晴雨表，改变治疗方案，并确保遵守。特别是在第二阶段，我们将设计、构建和临床评价遥测套管设计，升级和集成任务识别和FES算法，并升级用户界面软件。将在50例卒中受试者中对UHTS进行临床评价，以确保临床疗效。我们假设UHTS将1）准确传输数据2）准确检测治疗任务并在需要时应用FES，3）提供有效的受试者反馈，以及4）改善运动恢复。所提出的不受束缚的家庭治疗系统应加速时间进程，并增加中风导致的上肢运动缺陷的功能恢复量。该系统将包括一个袖子，用户可以在他们的手臂上滑动，这将测量肌肉活动和运动，并通过视频接口提供实时反馈。该系统将提供一个以家庭为基础的系统，用于继续和监测治疗，并为贫困者提供更好的治疗机会。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess an Untethered Home Therapy System (UHTS). The proposed system should speed the time course and increase the amount of functional recovery from upper extremity motor deficits resulting from a stroke. There currently has been tremendous growth and active research into brain plasticity and motor relearning after stroke. The proposed UHTS will provide a home-based system for continuing and monitoring therapy. Allowing patients to continue therapy at home with flexibility around their schedule should increase therapy time and hence functional improvement. Additionally, it will provide underprivileged better access for therapy. The patient and/or their caregiver could be easily trained to use the UHTS. The proposed UHTS will utilize wearable sensing and stimulating technology to automatically modulate functional electrical stimulation (FES) and improve therapy. The UHTS will employ a lightweight, easy to wear sleeve embedded with dry surface electromyography (EMG) electrodes, motion sensors, a stimulator unit, and radio transceiver. The untethered design will increase patient safety and allow patients to break without removing the device. EMG and kinetic data will be transmitted from the sleeve to a nearby laptop computer. A dynamic clinical movie will instruct subject therapy tasks, including a variety of simple and complex arm movements, grasp force tracking, EMG and/or position tracking, and grasp force tasks. Each task will be repeated for a specific clinician prescribed time period. By monitoring EMG and kinetic signals we will discriminate therapy tasks, monitor compliance time, and provide feedback. Additionally, movements, coordination patterns, and/or EMG will be used as inputs to an algorithm trained to output an appropriate level of FES to target muscles that will assist therapy. In other words, it will automatically detect when a user is trying to perform a therapy task they cannot voluntarily complete and assist with FES. A unique software interface will encourage patients through movie-based instruction, real-time feedback, and physician defined therapy goals. Quantitative measures related to functional improvement will be calculated and presented to clinicians in reports. Reports will be transmitted from patients' homes to a physician's office via the Internet so therapy can be monitored and modified on-line. Monitoring home therapy should give physicians a barometer for changing treatment protocols and ensuring compliance. Specifically during Phase II we will design, build, and clinically evaluate the telemetry sleeve design, upgrade and integrate algorithms for task discrimination and FES, and upgrade the user interface software. The UHTS will be clinically evaluated with fifty stroke subjects to ensure clinical efficacy. We hypothesize the UHTS will 1) accurately transmit data 2) accurately detect therapy tasks and apply FES when required, 3) provide effective subject feedback, and 4) improve motor recovery. The proposed untethered home therapy system should speed the time course and increase the amount of functional recovery from upper extremity motor deficits resulting from a stroke. The system will include a sleeve that the user can slip over their arm which will measure muscle activity and motion and supply real-time feedback with a video interface. The system will provide a home-based system for continuing and monitoring therapy and provide the underprivileged better access for therapy.