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

用于偏瘫上肢远程康复的腕戴式传感器

• 批准号: 9380967
• 负责人: Paolo Bonato
• 金额: $ 73.92万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-08 至 2020-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9380967
• 关键词: Acceleration; Accelerometer; Activities of Daily Living; Address; Affect; Algorithms; Behavior; Bilateral; Biofeedback; Biomedical Technology; Boston; Caring; Categories; Chronic; Clinical; Clinical Research; Consumption; Data; Development; Devices; Engineering; Exercise; Fee-for-Service Plans; Feedback; Geography; Goals; Health Insurance Portability and Accountability Act; Home environment; Hospitals; Impairment; Individual; Insurance Coverage; Intervention; Interview; Laboratories; Life; Limb structure; Living Wills; Longitudinal Studies; Measures; Modeling; Monitor; Motion; Motor; Motor Activity; Movement; Nature; Nervous System Trauma; Neuraxis; Neuronal Plasticity; New England; Occupational Therapy; Outcome Measure; Patients; Performance; Phase; Physical Medicine; Physical therapy; Process; Provider; Published Comment; Recovery; Rehabilitation Outcome; Rehabilitation therapy; Research Infrastructure; Safety; Scientist; Secure; Severities; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Stroke; System; Technology; Testing; Therapeutic Intervention; Time; Training; Transportation; United States National Institutes of Health; Upper Extremity; Upper limb movement; Visit; Visual; Wireless Technology; Wolves; Wrist; arm; arm movement; base; clinical practice; commercialization; constraint induced movement therapy; cost; cost effective; cost outcomes; design; dosage; equilibration disorder; exercise regimen; field study; health care service; hemiparesis; improved; improved outcome; innovation; limb movement; motor control; motor function recovery; programs; public health relevance; remote sensor; sensor; socioeconomics; standard care; technology development; telehealth; telehealth systems; telerehabilitation; traditional therapy; usability; wearable device; web site

 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.

 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能力丧失，这种情况在一侧肢体中比另一侧更为明显BioSensics 与 Spaulding 的运动分析实验室合作，尽管存在相当大的困难，但在日常生活活动中使用或尝试使用受影响的肢体可以刺激神经可塑性和运动功能恢复。康复医院将开发用于中风后运动再训练的腕戴式传感器，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，提醒患者在家庭环境中进行每日规定的运动控制练习，并评估。我们努力在传统疗法中添加使用腕戴式传感器的长期监测和生物反馈，以提高中风后的运动能力，特别是在由于高剂量的物理和职业治疗而无法实施的情况下。保险范围、缺乏交通、所提出的设备是唯一旨在鼓励在日常生活活动中使用受影响肢体的远程医疗系统。现有许多技术可以使用可穿戴传感器远程监测运动，但没有一个能够满足偏瘫患者的特定需求。因此，我们为该合作项目组建的团队包括来自 BioSensics（一家私营生物医学技术开发公司）和 Spaulding 的工程师、冠军和科学家，这是在该领域开发首个市场技术的重大机会。康复医院（新英格兰最大的康复医学提供商）在 Fast-Track 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日常运动摘要，并通过 WiFi 或 LAN 将数据上传到符合 HIPAA 标准的服务器，和一个网站buffons 可以用来可视化数据并远程设置患者特定的锻炼方案和活动目标。我们还将在 Spaulding 康复医院进行一项可用性研究和临床研究，该临床研究将比较 30 名中风后上肢偏瘫患者的康复结果。接受标准护理和补充家庭治疗的患者以及接受相同干预但使用拟议系统的 30 名患者 由于 1) 市场规模，2) 颠覆性，拟议技术具有巨大的商业化潜力。我们首先进入市场的技术的性质，以及 3) 国家正在推动从当前的按服务收费的医疗模式向负责任的护理组织标准的转变，我们将在完成后拥有一款可上市的设备。第二阶段计划在第三阶段期间上市，等待 FDA 批准。