Interactive Sensor Technology to Measure Adherence to Prescribed Therapeutic Foot

描述（由申请人提供）：规定的鞋类，如PisticCast Walkers，用于减少足底的有害压力，以预防和治疗糖尿病足溃疡（DFU）。虽然是DFU愈合和预防的关键组成部分，但患者对这些器械的依从性非常差，这是通过患者访谈和初步客观评估确定的。使用“现成的”活动监测仪对依从性进行客观监测，提供了一些关于依从性和伤口愈合的有价值的信息，然而，迄今为止使用的方法有几个显著的限制，不适合在研究环境之外使用。这种方法仅限于评估步行过程中的足部负荷，因此忽略了站立时足部的显著负荷。此外，没有识别传感器是否被佩戴的方法，从而导致活动/依从性值被显著低估。最后，从这些设备计算粘附是相当劳动密集的，并且不能在真实的时间内完成。在该提案中，我们开发了一种创新的低成本技术，可以通过向患者发出警报通知和向临床医生提供有价值的数据记录器信息来帮助提高患者依从性。所提出的系统将广泛可用的廉价设备与创新的身体活动监测技术相结合，以提高患者对穿着处方鞋的依从性。该设备由集成在受试者的鞋中的有源RFID标签（射频识别）以及身体佩戴的传感器组成，该传感器包括RFID标签读取器和基于微机电系统（MEMS）技术的运动传感器，用于监测自发的日常身体活动。RFID标签将充当接近传感器，其范围限于患者身体的长度。因此，为了将身体活动分类为与规定的鞋类粘附，记录活动的MEMS传感器必须同时检测鞋类在传感器范围内（例如，被穿着）。所建议的技术是我们使用不显眼的身体可穿戴技术实时监测自发日常身体活动的工作的延伸。身体佩戴传感器实时测量特定的身体姿势，例如坐、走、站和躺，并且还能够通过监测由于呼吸引起的胸部运动来测量患者佩戴传感器的顺应性。该软件算法足够灵敏和具体，以集成警报，如果受试者不安全地走动，没有RFID标签的鞋子。(e.g.,走五步以上）。如果RFID标签超出范围（即受试者没有穿鞋子），传感器单元将通知警报（通过声音或振动），并将在板载存储系统中标记警报时间。在研究的临床部分中，设计了两种不同的测试来解决其有效性以及其在以下方面的应用：（a）与先前的对处方鞋的依从性的测量相比，对患者依从性的量化（例如，面对面访谈），以及（B）调查患者的鞋类行为响应于常用实践的变化，例如解决患者偏好、患者教育以及警报的使用。建议的技术可以立即改变糖尿病足部护理管理，使临床医生能够更好地管理糖尿病伤口护理。它还可能导致通过改善受试者对规定鞋类的坚持和允许日常体力活动的剂量来实现智能足部溃疡预防策略。最后，该设备及其收集的数据也可以作为有价值的患者教育工具。 公共卫生相关性：使用专门的鞋，限制物理应力的脚在负重活动是一个关键因素，在预防和治疗糖尿病足伤口 （溃疡）;然而，患者通常仅在其日常活动的一小部分中穿着鞋。该项目旨在开发一种不显眼的监测器，用于识别患者在日常体力活动中使用鞋类的情况。该装置可用于向临床医生提供关于患者依从性的有价值的信息，并且还可用作通过在患者活动而不穿鞋时向患者提供警告警报来直接改善依从性的工具。

DESCRIPTION (provided by applicant): Prescribed footwear, such as Removable Cast Walkers, are used to reduce harmful pressures on the bottom of the foot for prevention and treatment of diabetic foot ulceration (DFU). Although a key component to the healing and prevention of DFU, patient adherence with these devices is excessively poor as determined by patient interviews and initial objective assessments. The use of "off the shelf" activity monitors for objective monitoring of adherence has provided some valuable information regarding adherence and wound healing, however, the methodology used to date has had several significant restraints and is not suitable for use outside of the research setting. This methodology is limited to the assessment of foot loading during walking and thereby ignores the significant loading of feet that occurs while standing. Also there is no means of identifying whether sensors were worn, allowing for significantly underreported activity/adherence values. Lastly, the calculation of adherence from these devices is quite labor intensive and cannot be done in real time. In this proposal, we develop an innovative and low cost technology that could help improve patient adherence via both an alarm notification to the patient and valuable data logger information provided to clinician. The proposed system combines a widely available inexpensive device with innovative physical activity monitoring technology for improving patients' adherence to wearing prescribed footwear. The device consists of an active RFID tag (Radio-frequency identification) integrated in the subject's footwear, together with a body worn sensor that includes an RFID tag reader and motion sensors based on micro-electro-mechanical systems (MEMS) technology for monitoring spontaneous daily physical activity. The RFID tag will act as a proximity sensor, with the range limited to the length of the patient's body. Therefore for physical activity to be classified as adherent with the prescribed footwear, the MEMS sensor recording the activity must concurrently detect the footwear as being within sensor range (e.g. being worn). The suggested technology is an extension of our work in monitoring spontaneous daily physical activities in real-time using unobtrusive body wearable technology. The body worn sensor measures specific body postures in real-time, such as sitting, walking, standing, and lying down and is also capable of measuring patients' compliance in wearing the sensor by monitoring chest movement due to respiration. The software algorithm is sensitive and specific enough to integrate an alarm, should the subject ambulate unsafely without their RFID tagged footwear. (e.g., walk more than five steps). In case that the RFID tag is out of range (i.e. subject didn't wear the footwear), the sensor unit will notify an alarm (via sound or vibration) and will mark the time of the alarm in the on-board memory system. In the clinical part of the study, two different tests are designed to address its validity as well as its application in (a) quantification of patient adherence as compared to previous measures of adherence to prescribed footwear (e.g. face-to-face interview) while ambulating at home and in the community and (b) investigating changes in patients' footwear behavior in response to commonly used practices, such as addressing patient preferences, patient education; and use of alarm. The suggested technology could make an immediate difference in diabetic foot care management and enable clinicians to better manage diabetic wound care. It may also lead to smart foot ulcer prevention strategies via improving subjects' adherence to prescribed footwear and allowing for dosage of daily physical activity. Lastly this device and the data gathered by it may also serve as a valuable patient education tool. PUBLIC HEALTH RELEVANCE: The use of specialized footwear that limits physical stress to the feet during weight bearing activities is a key factor in the prevention and treatment of diabetic foot wounds (ulcers); however, patients generally wear the footwear for only a small fraction of their daily activities. This project seeks to develop an unobtrusive monitor that will identify patients' use of their footwear during their daily physical activity. This device may be used to provide clinicians valuable information regarding patient compliance and also may be used as a tool to directly improve compliance by providing a warning alert to patients when they are active while not wearing their footwear.