BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline

BandPass：肌肉减少症和功能衰退的远程监测系统

• 批准号: 10697080
• 负责人: Ryan Joseph Halter
• 金额: $ 91.92万
• 依托单位: SYNCHROHEALTH LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697080
• 关键词: Accelerometer; Acute; Address; Adherence; Affect; Age; Algorithms; American; Bluetooth; Businesses; Calibration; Caring; Cessation of life; Classification; Clinical; Cognitive; Computer software; Consumption; Custom; Data; Data Collection; Data Science; Device Designs; Devices; Diagnosis; Distal; Drops; Elasticity; Elderly; Electronics; Exercise; Feedback; Future; Goals; Hand Strength; Health; Healthcare; Home; Hour; Housing; Infrastructure; Institutionalization; Internet; Interview; Lead; Marketing; Measurement; Measures; Medical Device; Methods; Monitor; Morbidity - disease rate; Motion; Muscular Atrophy; Musculoskeletal; Non-Invasive Detection; Outcome; Pain; Patient Monitoring; Patient Monitoring System; Patient Self-Report; Patients; Persons; Phase; Physical Function; Physical Performance; Physicians; Pilot Projects; Positioning Attribute; Predictive Analytics; Procedures; Production; Quality of life; Recommendation; Recovery; Recovery of Function; Recreation; Reporting; Research Design; Resistance; Resolution; Resources; Risk; Self-Help Devices; Services; Site; Small Business Technology Transfer Research; Sports; Structure; Surveys; System; Technology; Testing; Time; Training; Tube; Variant; Vision; Visual; Writing; age group; aging in place; classification algorithm; clinically relevant; cloud based; commercialization; compliance behavior; computing resources; cost; dashboard; data communication; data exchange; data visualization; design; diaries; disability; disability risk; evidence base; exercise adherence; exercise physiologist; exercise program; exercise training; experience; frailty; functional decline; handheld mobile device; improved; innovation; mHealth; machine learning algorithm; manufacture; mobile application; monitoring device; muscle form; muscle hypertrophy; muscle regeneration; muscle strength; novel; operation; patient oriented; physical therapist; preservation; remote monitoring; remote patient monitoring; remote sensing; resistance exercise; sarcopenia; satisfaction; sensor; standard care; success; transmission process; usability; user centered design; user-friendly; validation studies; verbal

PROJECT SUMMARY Clinical Need: Sarcopenia and frailty represent significant and growing clinical challenges whose rates increase with age, and place patients at risk for functional decline, institutionalization, or death. Resistance exercises are strongly recommended in this age group to promote muscle regeneration and strength and are routinely a part of evidence-based home exercise programs prescribed by physical therapists. If conducted as advised, patients can recover from acute illness, preserve their independence, and reduce their risk of morbidity. Current Clinical Challenge: A major gap in home exercise programs is a clinician's reliance on self-report diaries or verbal reports that may be inaccurate or may be subject to recall bias. Remote patient monitoring systems that measure, track, analyze, and provide patient-oriented feedback may overcome these limitations and have the potential to enhance exercise adherence. An at-home device that monitors and transmits exercise data to the user and clinician represents a potential solution to this clinical challenge. Our product – BandPass – SynchroHealth is a small business entity that developed a remote monitoring solution to fulfil this market need. BandPass consists of a remote-sensing, Bluetooth-enabled, resistance exercise band that will accurately gauge force through potentiometric and multi-axial sensors, rigidly fixed to elastic-tubing purposely designed for resistance exercise training. The device is visually similar to currently available exercise bands familiar to clinicians and patients. However, the device has a significantly novel addition of integrating force monitoring while connecting to the cloud through a patient app. A mobile app and a clinician cloud-based platform will provide computational resources for data visualization, storage, and analysis. This will enable direct patient feedback, clinical monitoring of patient compliance and progress, and will serve as a platform for more advanced operations such as automatic exercise-type classification to ease user burden (e.g., minimizing required interactions between the user and mobile device). Specific Objectives: We propose to commercialize the custom design electronics and housing for BandPass and perform in-lab validation studies of device accuracy, precision, and long-term stability. BandPass will be interfaced to a mobile app and cloud-based platform for its data transmission, storage, and analysis. We will collect data on correct and incorrect usage of BandPass to drive classification algorithms that will facilitate automatic guidance to patients in completing effective exercise programs. Then, we will conduct a user-centered design study to examine how to communicate data to patients and clinicians. Finally, we will deploy BandPass in a pilot study to show initial efficacy at home. Future Directions: SynchroHealth's vision is to develop a mobile health, user-friendly platform using internet-connected devices to improve the quality of life and physical function of older adults. At the end of Phase II, we will have demonstrated BandPass' functionality by providing evidence that it can be deployed at home. This will position us for commercial success by preparing this Class II exempt medical device for marketing, production, and execution of commercial engagements.

项目总结