Phase IIB: Portable Device for Telecare Monitoring of Elderly People

 描述(由申请人提供)：我们建议进一步开发、现场测试和商业化一种可靠和健壮的传感器技术，允许客观评估家中和社区老年人的日常体力活动、跌倒风险、虚弱和活动组织。这是IIB阶段STTR应用程序。在第一和第二阶段，LLC与高级运动性能跨学科联盟和亚利桑那大学亚利桑那老龄中心合作，开发并经临床验证的复杂信号处理算法和相关传感器硬件，使用佩戴在躯干上或作为吊坠的单一运动传感器(三轴加速计)来监测老年人的体力活动和跌倒。我们的第一阶段/第二阶段工作产生了两个商业可用产品。PAMSys(Tm)是一个可穿戴的传感器平台，用于长期监测与活动相关的参数，这些参数对于客观评估老年人的体力活动、功能、虚弱和跌倒风险非常重要。PAMSys(Tm)主要是一种研究工具，在药物临床试验和其他比较结果的临床研究中有着广泛的应用。ActivePERS(Tm)是一款低成本的医疗警报挂件，具有自动跌倒检测、活动监控和不合规警报功能。ActivePERS(Tm)是一种消费产品，已经通过与远程保健和医疗警报市场的9家公司持续的合作伙伴关系实现了商业化。通过这个IIB阶段项目，我们建议改进我们的ActivePERS(Tm)技术，以实现对跌倒风险和脆弱状态的长期远程监控。使用物理活动远程监测和反馈对跌倒/脆弱风险进行早期诊断、干预和远程监测的客观方法尚未开发出来。这种技术可以用来识别指示早期变化的模式，从而允许对高危老年人进行早期诊断和干预。此外，它还将能够对日常生活中跌倒/虚弱的风险进行远程和持续的筛查，支持自主权和生活质量，并限制临床干预的需要。此外，这项技术可以提供客观的工具来评估康复对运动功能的影响，从而根据不同干预措施的相对有效性来评估摔倒/虚弱的风险。建议的技术有很大的商业化潜力，原因是1)市场的规模，2)我们率先投放市场的技术的破坏性，以及3)正在进行的国家努力，以加强预防跌倒。我们将在这个项目完成时拥有一个市场就绪的设备，并计划在第三阶段推出市场。

 DESCRIPTION (provided by applicant): We propose to further develop, field test, and commercialize a reliable and robust sensor technology that allows the objective assessment of daily physical activity, risk of falling, frailty, and activity organization among older adults in he home and community. This is a Phase IIB STTR application. During Phases I&II BioSensics, LLC, in collaboration with the Interdisciplinary Consortium on Advanced Motion Performance and the Arizona Center on Aging at the University of Arizona, developed and clinically validated sophisticated signal processing algorithms and associated sensor hardware to monitor physical activity and falls in older adults using a single motion sensor (tri-axial accelerometer) worn on the torso or as a pendant. Our Phase I/II work resulted in two commercially available products. PAMSys(tm) is a wearable sensor platform for long-term monitoring of activity related parameters that are of significant importance for objective assessment of physical activity, functioning, frailty, and fall risk of older adults. PAMSys(tm) is primarily a research tool with broad applicatons in pharmaceutical clinical trials and other comparative outcomes clinical research. ActivePERS(tm) is a low-cost medical alert pendant with automatic fall detection, activity monitoring, and non-compliance alerts. ActivePERS(tm) is a consumer product that has been commercialized through 9 on-going partnerships with companies in the telehealth and medical alert markets. With this Phase IIB project we propose to improve our ActivePERS(tm) technology to enable long-term remote monitoring of fall risk and frailty status. An objective method for earl diagnosis, intervention and remote monitoring of the risk of falling/frailty using physical activit telemonitoring and feedback has not yet been developed. Such technology could be used to identify patterns indicative of early changes allowing early diagnosis and intervention of at-risk elders. In addition, it will enable remote and continuous screening of the risk of falling/frailty during daily life, supporting autonomy and quality of life, and limiting the need for clinical intervention. Moreover, the technology can provide an objective tool to evaluate the effects of rehabilitation on motor function, and hence on reductions in the risk of falling/frailty based on te relative efficacy of different interventions. There is a significant commercialization potential fo 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 towards increased efforts towards fall prevention. We will have a market-ready device by the completion of this project with plans for a market launch during Phase III.