Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders

用于吞咽功能和疾病的机械兼容可穿戴监测系统的开发和验证

• 批准号: 9979848
• 负责人: Chi Hwan Lee
• 金额: $ 18.77万
• 依托单位: PURDUE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-20 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979848
• 关键词: Adult; Affect; Anatomy; Area; Awareness; Basic Science; Biocompatible Materials; Biofeedback; Biomedical Technology; Clinical Trials; Collection; Complex; Data; Deglutition; Deglutition Disorders; Development; Device or Instrument Development; Devices; Dimensions; Disease; Encapsulated; Ensure; Environment; Equipment; Exercise; Feedback; Foundations; Future; Goals; Head and Neck Cancer; Head and neck structure; Health; Health Services Accessibility; Human; Human body; Individual; Investments; Measurement; Mechanics; Medical; Mission; Modeling; Modernization; Monitor; Movement; Muscle; Needs Assessment; Oral; Outcome; Palate; Patient-Focused Outcomes; Patients; Performance; Preclinical Testing; Protocols documentation; Public Health; Quality of life; Rehabilitation therapy; Research; Safety; Service provision; Services; Signal Transduction; Skin; Speech; Stroke; Structure; Surface; System; Technology; Testing; Thinness; Thyroid Gland; Time; Tongue; Transducers; Validation; Visit; Wireless Technology; Work; biomaterial compatibility; clinical investigation; compliance behavior; data acquisition; dysphagia rehabilitation; exercise rehabilitation; experience; experimental study; flexibility; follow-up; improved; innovation; monitoring device; non-compliance; novel; portable monitoring; pre-clinical; pressure; programs; prototype; rehabilitation service; rehabilitation technology; rural area; sensor; social integration; telerehabilitation; wearable device; wearable sensor technology

Rural areas often experience shortages of medical professionals and technologies. Such shortages significantly affect patient health and outcomes, justifying investments in tele-rehabilitation technology to deliver these services remotely. Modern technologies enable the use of portable monitoring systems, facilitating clinicians to remotely collect biofeedback signals for rehabilitation practices and enabling patients to use real-time biofeedback. However, existing devices suffer from rigid or semi-flexible platforms, which are not suited for interfacing with the soft, curvilinear, and dynamic parts of the human body (e.g., the submental (under the chin) and intraoral areas). This often results in poor data acquisition and in discomfort, thereby affecting patient compliance. Moreover, poor treatment compliance is identified as a critical barrier to rehabilitation, and is primarily attributed to expensive, difficult-to-use or limited availability of equipment/devices, and inability to physically access treatment. This team's long-term goal is to provide a complete set of advanced wearable devices that can be easily and accurately utilized for day-to-day tele-rehabilitation needs. The objective of this project is to develop and start validating a collection of inexpensive soft, thin monitoring systems that can perfectly fit into/on the human body, and then wirelessly provide accurate real-time data to patients and clinicians. Two curvilinear and structurally complex areas of the human body, the submental and intraoral areas, will be targeted for the development of these novel, wearable transducers. Measurements from these areas are essential during rehabilitation of swallowing, a vital body function that is used as the model for this proposal. Swallowing disorders (dysphagia) are common in many diseases (e.g., head and neck cancer, stroke, etc.) and significantly affect health, quality of life, and social integration. To accurately monitor swallowing signals, intimate attachment of sensors to the anatomically challenging head/neck skin and intra- oral environment is essential. To attain the stated objective, the following specific aims are proposed: 1) to develop and conduct benchtop testing of a wireless soft, thin sensor patch tailored for submental muscle monitoring, 2) to develop and conduct benchtop testing of a wireless palatal plate sensor tailored for intraoral pressure/movement monitoring, and 3) to conduct iterative pre-clinical experiments in healthy adults to validate the safety, ease-of-use/comfort, and signal quality of the sensors during swallowing tasks and exercises. The proposed research is innovative, as it will develop novel, wearable tele-monitoring systems that are tailored for two challenging areas anatomically. This contribution will be significant because it will offer a first-of-its-kind, mechanically compliant, inexpensive, and reliable wearable system for swallowing signals monitoring. This work will then form the basis for developing dysphagia tele-rehabilitation protocols and completing a follow-up clinical trial. Upon project completion, a foundational platform will have been established that can be extended to a range of disorders, including speech and oral sensorimotor disorders.

农村地区往往缺乏医疗专业人员和技术。这种短缺 显著影响患者的健康和结果，证明投资远程康复技术， 远程提供这些服务。现代技术使得能够使用便携式监测系统， 便于临床医生远程收集用于康复实践的生物反馈信号，并使患者能够 使用实时生物反馈。然而，现有的装置受到刚性或半柔性平台的影响，这些平台不是柔性的。 适合于与人体的柔软、曲线和动态部分（例如，颏下 （在下巴下）和口内区域）。这通常导致不良的数据采集和不适，从而 影响患者的依从性。此外，治疗依从性差被认为是治疗的关键障碍。 康复，并主要归因于昂贵，难以使用或有限的设备/装置， 以及无法接受治疗该团队的长期目标是提供一套完整的 先进的可穿戴设备，可轻松准确地用于日常远程康复需求。 该项目的目标是开发并开始验证一系列廉价的软、瘦监控 系统可以完美地融入人体，然后无线提供准确的实时数据， 患者和临床医生。人体的两个曲线和结构复杂的区域，颏下和 口内区域，将针对这些新颖的，可穿戴传感器的发展。测量从 这些区域在吞咽的康复过程中是必不可少的，吞咽是一种重要的身体功能， 这个提议。吞咽障碍（吞咽困难）在许多疾病中是常见的（例如，头颈癌， 中风等）并严重影响健康、生活质量和社会融合。准确监测 吞咽信号，传感器与解剖学上具有挑战性的头部/颈部皮肤的紧密连接， 口腔环境至关重要。为达到上述目标，建议的具体目标如下： 开发并进行针对颏下肌肉量身定制的无线软、薄传感器贴片的台架测试 监测，2）开发并进行针对口内的无线腭板传感器的实验室测试 压力/运动监测，以及3）在健康成人中进行迭代临床前实验，以验证 吞咽任务和练习期间传感器的安全性、易用性/舒适性和信号质量。的 拟议的研究是创新的，因为它将开发新的，可穿戴的远程监测系统，为 解剖学上两个具有挑战性的区域。这一贡献将是重要的，因为它将提供一个前所未有的， 这是一种机械兼容、廉价且可靠的可穿戴系统，用于吞咽信号监测。这 这项工作将为制定吞咽困难远程康复方案和完成后续工作奠定基础 临床试验项目完成后，将建立一个可扩展的基础平台 包括言语和口腔感觉运动障碍。