Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper-Extremity

 描述（由申请人提供）：用于偏瘫上肢远程康复的腕戴式传感器：中风和中枢神经系统损伤的其他原因可能导致运动控制的衰弱性丧失，这种丧失在一个肢体中往往比另一个肢体更明显。在日常生活活动中使用或尝试使用患肢，尽管相当困难，但可以刺激神经可塑性和运动功能恢复。BioSensics与Spaulding康复医院的运动分析实验室合作，将开发用于中风后运动再训练的腕戴式传感器。我们简单的技术将鼓励患者在日常生活活动中使用患肢，提醒患者在家庭环境中进行日常规定的运动控制练习，并评估这些练习期间肢体运动的质量。我们假设，在传统治疗中使用腕戴式传感器增加长期监测和生物反馈将改善中风后的运动能力;特别是在由于保险范围，缺乏交通，地理或其他限制因素而无法进行高剂量物理和职业治疗的情况下。拟议的设备是唯一的远程医疗系统，旨在鼓励在日常生活活动中使用受影响的肢体。存在许多使用可穿戴传感器远程监测运动的技术，但没有一种技术能够满足轻偏瘫患者的特定需求。因此，在这一领域有一个重要的机会来开发第一个市场技术。我们为这个合作项目组建的团队包括来自BioSensics（一家私人生物医学技术开发公司）和Spaulding康复医院（新英格兰最大的康复医学提供商）的工程师、临床医生和科学家。在这个快速跟踪SBIR项目的第一阶段，我们将开发腕戴式传感器和测试算法，用于根据这些传感器测量的加速度评估家庭环境中上肢运动的质量和数量。在第二阶段，我们将为拟议的系统开发远程医疗基础设施，包括一个家庭基站，该基站从腕戴式传感器接收每日运动摘要，并通过WiFi或LAN将数据上传到符合HIPAA的服务器，以及一个网站，临床医生可以使用该网站来可视化数据并远程设置患者特定的运动方案和活动目标。我们还将在Spaulding康复医院进行可用性研究和临床研究。该临床研究将比较30例接受标准护理和补充家庭治疗的中风后上肢轻偏瘫患者和30例接受相同干预但使用拟议系统的患者的康复结果。由于1）市场规模，2）我们的首次上市技术的破坏性，以及3）国家正在推动从目前的收费服务医疗保健模式过渡到责任医疗组织标准，因此拟议技术具有巨大的商业化潜力。我们将在第二阶段完成时拥有一个市场就绪的设备，并计划在第三阶段期间上市，等待FDA批准。

 DESCRIPTION (provided by applicant): Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper-Extremity: Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. BioSensics, in partnership with the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, will develop wrist-worn sensors for motor retraining after stroke. Our simple technology will encourage affected limb use during the performance of activities of daily living, will remind patients to perform daily prescribed motor control exercises in the home environment, and will assess the quality of limb movement during these exercises. We hypothesize that adding long-term monitoring and biofeedback using wrist-worn sensors to traditional therapies will improve motor ability following stroke; particularly in cases where a high dosage of physical and occupational therapy is not feasible due to insurance coverage, lack of transportation, geography, or other limiting factors. The proposed device is the only telehealth system designed to encourage usage of the affected limb during activities of daily living. Many technologies exist to remotely monitor movement using wearable sensors, but none address the specific needs of patients with hemiparesis. Therefore, there is a significant opportunity to develop a first-to-market technology in this space. The team we have assembled for this collaborative project includes engineers, clinicians, and scientists from BioSensics (a privately held biomedical technology development company) and Spaulding Rehabilitation Hospital (the largest provider of rehabilitation medicine in New England). During Phase I of this Fast-Track SBIR project we will develop the wrist-worn sensors and test algorithms for assessing the quality and quantity of upper-limb movement in the home environment based on acceleration measured by these sensors. During Phase II we will develop the telehealth infrastructure for the proposed system, including a home base station that receives daily movement summaries from the wrist-worn sensors and uploads the data via WiFi or LAN to a HIPAA compliant server, and a website that clinicians can use to visualize data and remotely set patient specific exercise regimens and activity goals. We will also conduct a usability study and a clinical study at Spaulding Rehabilitation Hospital. The clinical study will compare rehabilitation outcomes between 30 patients with upper-extremity hemiparesis following stroke who receive standard care and supplemental home-based therapy and 30 patients who receive the same intervention but use the proposed system. There is a significant commercialization potential for the proposed technology due to 1) the size of the market, 2) the disruptive nature of our first-to-market technology, and 3) the ongoing national push for a transition from the current fee- for-service healthcare model to accountable-care-organization standards. We will have a market-ready device by the completion of Phase II with plans for a market launch during Phase III, pending FDA approval.