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

 描述(申请人提供)：腕式传感器用于偏瘫上肢的远程康复：中风和其他导致中枢神经系统损害的原因可导致运动控制的衰弱丧失，通常在一个肢体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，尽管存在相当大的困难，但可以刺激神经可塑性和运动功能的恢复。BioSensics将与斯波尔丁康复医院的运动分析实验室合作，开发用于中风后运动再训练的手腕传感器。我们的简单技术将鼓励患者在日常生活活动中使用受影响的肢体，将提醒患者在家庭环境中进行每日指定的运动控制练习，并将在这些练习中评估肢体运动的质量。我们假设，在传统疗法的基础上增加使用手腕佩戴传感器的长期监测和生物反馈将改善中风后的运动能力；特别是在由于保险覆盖、缺乏交通、地理或其他限制因素而无法进行大剂量物理和职业治疗的情况下。拟议的设备是唯一一个远程保健系统，旨在鼓励在日常生活活动中使用受影响的肢体。有许多技术可以使用可穿戴传感器远程监控运动，但没有一种技术能满足偏瘫患者的特定需求。因此，在这一领域开发首个上市技术是一个重要的机会。我们为这个合作项目组建的团队包括来自BioSensics(一家私人持股的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。在这个快速通道SBIR项目的第一阶段，我们将开发腕部佩戴的传感器和测试算法，以基于这些传感器测量的加速度来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，它从手腕佩戴的传感器接收每日运动摘要，并通过WiFi或局域网将数据上传到符合HIPAA标准的服务器，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。我们还将在斯波尔丁康复医院进行可用性研究和临床研究。这项临床研究将比较30名接受标准护理和补充家庭治疗的中风后上肢偏瘫患者和30名接受相同干预但使用拟议系统的患者的康复结果。由于1)市场的规模，2)我们的首批上市技术的颠覆性，以及3)国家正在推动从目前的按服务收费的医疗保健模式向责任护理组织标准的过渡，建议的技术具有巨大的商业化潜力。我们将在第二阶段完成时推出市场就绪的设备，并计划在第三阶段上市，等待FDA的批准。

 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.