Interactive Sensor Technology to Measure Adherence to Prescribed Therapeutic Foot

交互式传感器技术可测量对足部规定治疗的遵守情况

• 批准号: 8320251
• 负责人: Bor-rong Chen
• 金额: $ 19.23万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-16 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8320251
• 关键词: Address; Adherence; Algorithms; Ankle; Automobile Driving; Award; Behavior; Braces-Orthopedic appliances; Caring; Chest; Clinical; Clinical Research; Communities; Computer software; Data; Detection; Devices; Diabetic Foot; Diabetic Foot Ulcer; Diabetic wound; Engineering; Evaluation; Event; Foot Ulcer; Frequencies; Gait; Grant; Healed; Home environment; Interview; Investigation; Knee; Lead; Length; Measurement; Measures; Mechanics; Memory; Methodology; Modification; Monitor; Motion; Movement; Notification; Patient Education; Patient Preferences; Patients; Phase; Physical activity; Posture; Prevention; Prevention strategy; Process; Radio; Reader; Research; Respiration; Risk; Sample Size; Shoes; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Stress; System; Technology; Testing; Therapeutic; Time; Ulcer; United States National Institutes of Health; Validation; Walkers; Walking; Weight-Bearing state; Work; Wound Healing; base; compliance behavior; cost; cost effective; design; diabetic; dosage; foot; healing; high risk; improved; innovation; kinematics; neglect; novel; orthotics; pressure; programs; response; restraint; sensor; software development; sound; time use; tool; treatment planning; user-friendly; vibration

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.

描述（由申请人提供）：规定的鞋类，例如可拆卸石膏助行器，用于减少足底的有害压力，以预防和治疗糖尿病足溃疡（DFU）。尽管这些设备是治疗和预防 DFU 的关键组成部分，但根据患者访谈和初步客观评估，患者对这些设备的依从性极差。使用“现成的”活动监测器来客观监测依从性，提供了一些有关依从性和伤口愈合的有价值的信息，但是，迄今为止使用的方法有几个显着的限制，不适合在研究环境之外使用。该方法仅限于评估步行期间的足部负荷，从而忽略了站立时足部的显着负荷。此外，无法识别传感器是否佩戴，从而导致活动/依从性值明显漏报。最后，这些设备的依从性计算相当耗费人力，并且无法实时完成。在本提案中，我们开发了一种创新且低成本的技术，可以通过向患者发出警报通知以及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的依从性。所提出的系统将广泛使用的廉价设备与创新的身体活动监测技术相结合，以提高患者穿着规定鞋类的依从性。该设备由集成在受试者鞋类中的有源 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，用于监测自发性运动。日常身体活动。 RFID标签将充当接近传感器，其范围仅限于患者身体的长度。因此，为了将身体活动归类为符合规定的鞋类，记录活动的 MEMS 传感器必须同时检测到鞋类在传感器范围内（例如，正在穿着）。建议的技术是我们使用不引人注目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。身体佩戴的传感器实时测量特定的身体姿势，例如坐、走、站、躺，还能够通过监测呼吸引起的胸部运动来测量患者佩戴传感器的依从性。软件算法足够灵敏和具体，如果对象在没有带有 RFID 标签的鞋子的情况下不安全地走动，可以集成警报。 （例如，步行超过五步）。如果 RFID 标签超出范围（即对象没有穿鞋），传感器单元将发出警报（通过声音或振动），并在板载存储系统中标记警报时间。在该研究的临床部分，设计了两种不同的测试来解决其有效性及其在以下方面的应用：(a) 与之前对规定鞋类的依从性测量（例如面对面访谈）相比，患者依从性的量化在家中和社区中走动，以及 (b) 调查患者鞋类行为的变化，以响应常用做法，例如解决患者偏好、患者教育；以及报警器的使用。建议的技术可以立即改变糖尿病足部护理管理，并使临床医生能够更好地管理糖尿病伤口护理。它还可以通过提高受试者对规定鞋类的遵守程度并允许进行日常体育活动来制定明智的足部溃疡预防策略。最后，该设备及其收集的数据还可以作为有价值的患者教育工具。