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: 9170095
• 负责人: Paolo Bonato
• 金额: $ 76.07万
• 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 2018-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9170095
• 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; 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; 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; 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（由适用提供）：用于远程上限的腕上磨削的腕部传感器：中枢神经系统损伤的中风和其他原因可能导致一个肢体中通常比另一个肢体更明显的运动控制损失。在日常生活，所需的考虑困难中使用或尝试使用受影响的肢体，刺激神经可塑性和运动功能恢复。与Spaulding康复医院的运动分析实验室合作的生物密度将开发中风后的腕部磨损传感器。我们的简单技术将鼓励在日常生活的活动过程中受影响的肢体使用，这会提醒患者在家庭环境中进行日常处方的运动控制练习，并将评估这些练习期间肢体运动的质量。我们假设，使用腕上磨损的传感器在传统疗法中添加长期监测和生物反馈将提高动作后运动能力。特别是在高剂量的物理和占用治疗由于保险范围，缺乏运输，地理或其他限制因素而无法可行的情况下。拟议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。存在许多技术，可以使用可穿戴传感器远程监测运动，但没有解决偏瘫患者的特定需求。因此，有很大的机会在该领域开发第一到市场技术。我们为这个合作项目组成的团队包括生物学（一家私有生物医学技术开发公司）的工程师，临床医生和科学家和Spaulding Rehabilitation Hospital（新英格兰最大的康复医学提供商）。在这个快速轨道SBIR项目的第一阶段，我们将根据这些传感器测量的加速度，开发戴腕部的传感器和测试算法，以评估家庭环境中上LIMB运动的质量和数量。在第二阶段期间，我们将为拟议系统开发远程医疗基础架构，包括一个家庭基站，该基础站从腕部磨损的传感器中接收日常移动摘要，并通过WiFi或LAN将数据上传到符合HIPAA的服务器，以及临床医生可以使用该网站来可视化数据并将数据可视化并设置特定于患者的运动方案和活动目标和活动目标。我们还将在Spaulding康复医院进行可用性研究和临床研究。临床研究将比较中风后30例上肢体偏瘫患者接受标准护理和补充家庭疗法的康复结局，并接受30例接受相同干预但使用拟议系统的患者。由于1）市场规模，2）我们第一到市场技术的破坏性，以及3）持续的全国推动，从当前的费用服务医疗保健模型过渡到负责任的医疗机构标准。我们将在II阶段的完成后，在第三阶段推出的计划之前，我们将拥有一台适用于市场的设备，等待FDA批准。