A Wireless Wearable System to Measure Adherence to Mind-Body Protocols

描述（由申请人提供）：项目摘要/摘要：提出了一种无线可穿戴系统，以评估对补充和替代医学（CAM）身心干预研究方案的依从性。该系统将利用最近开发的硅微机械传感器来测量重力矢量（加速度计）和角速率（陀螺仪）。数据将收集在真实的时间从这些传感器使用低功耗数字无线网络技术称为蓝牙。蓝牙网络是现在在许多商业上可用的手持计算机和智能蜂窝电话中可用的标准。蓝牙的使用将允许研究人员投资一套传感器，这些传感器将在未来许多年内与新的便携式计算和手机设备兼容。在一项使用冥想、瑜伽和太极等身心干预的研究方案中，小型无线传感器包被戴在身上。可以使用1至7个传感器封装。受试者在研究方案培训期间佩戴传感器。这用于收集身体运动的基线集。在研究过程中，传感器在身心干预期间佩戴。每个传感器位置处的3轴加速度和角速率感测信息被传输到手持计算机或智能手机。该记录的数据可以用于比较与基线数据集的空间和时间上的偏差，以确定顺应性指数。静态和状态变化偏差都可以测量和量化。将使用分析软件生成一份报告，显示研究有兴趣监测的方案部分的偏离百分比指数。第一阶段项目将为该系统开发一套硬件传感器和软件原型。将进行人体研究，以测试身心研究方案中系统的功能操作。项目叙述：确定任何干预措施的安全性和有效性至关重要。了解和准确测量患者和研究参与者遵守研究方案的程度是准确评估结果的重要信息。身心干预需要大量的参与者遵守特定的研究方案。研究冥想、瑜伽、太极拳和类似干预措施对健康影响的研究项目要求参与者以特定的形式和特定的协议定期自行参与这些练习。评估参与者对这些方案的依从性水平对于了解干预的剂量、疗效、安全性和可行性至关重要。

DESCRIPTION (provided by applicant): Project Summary/Abstract: A wireless wearable system is proposed to assess adherence to study protocols for complementary and alternative medicine (CAM) mind-body interventions. This system will utilize recently developed silicon micro machined sensors for measuring the gravity vector (accelerometers) and angular rates (gyroscopes). Data will be collected in real time from these sensors using a low power digital wireless network technology called Bluetooth. The Bluetooth network is a standard that is now available in many commercially available handheld computers and smart cell phones. The use of Bluetooth will allow a researcher to invest in a set of sensors that will be compatible with new portable computing and cell phone devices for many years to come. In a study protocol that uses mind body interventions such as meditation, yoga and tai chi, the small wireless sensor packages are worn on the body. Between 1 to 7 sensor packages can be used. A subject wears the sensors during the training for the study protocol. This is used to collect a baseline set of body movements. During the course of the study, the sensors are worn during the mind-body interventions. The 3 axis of acceleration and angular rate sensing information at each sensor location is transmitted to a handheld computer or smart cell phone. This recorded data can be used to compare the deviations both spatially and temporally from the baseline dataset to determine a compliance index. Both static state and change of state deviations can be measured and quantified. A report will be generated with analysis software that shows an index in percentage of deviations in segments of the protocol that the research is interested in monitoring. The phase I project will develop a prototype set of hardware sensors and software for the system. A human study will be conducted to test the functional operation of the system in a mind-body study protocol. Project Narrative: Determining the safety and efficacy of any intervention is vital. Understanding and accurately measuring the extent to which patients and study participants adhere to research protocols is essential information for accurate assessment of outcomes. Mind-body interventions require substantial participant adherence to specific study protocols. Research projects examining the health effects of meditation, yoga, tai chi, and similar interventions require participants to regularly engage in these practices on their own in specific formats and under specified protocols. Assessing the level of participant adherence to these protocols is essential in order to understand the dose, the efficacy, the safety, and the feasibility of the intervention.