CuffLink: Remotely Monitored Rotator Cuff Repair Rehabilitation at Home

CuffLink：在家远程监控肩袖修复康复

• 批准号: 10546661
• 负责人: Kevin M Bell
• 金额: $ 25.96万
• 依托单位: ELIZUR CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546661
• 关键词: Adherence; Adult; Clinic; Clinical; Clinical Data; Communication; Consensus; Cost Savings; Custom; Data; Decision Making; Development; Devices; Direct Costs; Ensure; Environment; Equilibrium; Equipment; Evaluation; Exercise; Facilities and Administrative Costs; Feedback; Future; Goals; Gold; Health Care Costs; Health system; Healthcare; Home; Instruction; Knee; Laboratories; Legal patent; Measures; Mechanics; Monitor; Motion; Movement; Online Systems; Operative Surgical Procedures; Optics; Orthopedic Surgery; Orthopedics; Outcome; Outpatients; Participant; Passive Range of Motion function; Patient Care; Patient Monitoring; Patient Recruitments; Patient Self-Report; Patient Triage; Patients; Pattern; Performance; Phase; Physical therapy; Physicians; Postoperative Period; Prevention; Process; Range of motion exercise; Reading; Recovery; Rehabilitation therapy; Resources; Risk; Rotator Cuff; Safety; Savings; Series; Services; Shoulder; Signal Transduction; Small Business Technology Transfer Research; Specialist; Stress; Structure; Supervision; Surgeon; Surveys; System; Technology; Testing; Time; United States; Universities; Visit; application programming interface; base; clinical decision-making; clinically relevant; commercialization; compliance behavior; cost; data streams; design; disability; exercise regimen; exercise rehabilitation; experience; healing; improved; instrument; mHealth; mobile application; motion sensor; novel; patient portal; phase 2 study; physical therapist; portability; post-operative rehabilitation; prevent; procedure cost; remote monitoring; repaired; research clinical testing; research facility; rotator cuff tear; rural area; satisfaction; smartphone Application; telehealth; telehealth systems; tool; usability

ABSTRACT Rotator cuff tears are the primary cause of shoulder disability in adults, generating between $3 and $12 billion in healthcare costs annually. Rotator cuff repair (RCR) surgery results in greater improvement than non-surgical options. However, post-RCR rehabilitation requires a careful balance of movement to prevent shoulder stiffness while keeping the shoulder stable to protect repair integrity. Current early rehabilitation involves passive range of motion exercises performed during out-patient physiotherapy. Together, ēlizur and the University of Pittsburgh propose to develop CuffLink, a telehealth system for post-RCR rehabilitation, by integrating two previous successful developments: the mechanical Strengthening & Stabilization Systems (SSS) and the remote monitoring capabilities of interACTION (iA). CuffLink will aid post- RCR rehabilitation by providing a safe, reliable and at-home means of mobilizing the shoulder, while allowing for remote monitoring. This reduces the need for costly in-patient visits in the early stage of rehabilitation, increases accessibility to care for patients with limited mobility and/or in rural areas, and increases communication and supervision by physicians and their staff through the clinician portal. First, a Delphi survey will be conducted with orthopaedic surgeons and physical therapists to understand their opinions on the current RCR best practices. Concurrently, an integrated movement monitoring application programming interface will be developed and refined according to the consensus established by the expert Delphi panel. This will result in the conversion of raw data signals from quantitative motion sensors in the SSS into clinically acceptable and telehealth ready data streams. Then, a mobile health system based on iA will be developed. This will include an app suite for patients and a clinician portal, which will provide exercise feedback to both patients and clinicians, and allow clinicians to monitor patient data and engage patients. Then, the accuracy and test-retest reliability of CuffLink will be validated using a group of RCR patients recruited primarily through the UPMC Orthopaedic Surgery clinics. Measured readings from CuffLink will be compared to a gold standard optical motion capture system, and participants will return to the testing facility a few days later to repeat the exercises. Finally, the feasibility, usability, and acceptability of CuffLink for use in patients’ homes will be assessed. These will be evaluated both quantitatively and qualitatively, and the results are expected to demonstrate high satisfaction. Successful completion of this project will result in a device that combines the safety of mechanical motion exercise equipment with quantitative motion tracking and remote monitoring to personalize and optimize patient recovery from RCR surgery at lower costs. It is expected that the device, CuffLink, will be ready for clinical evaluation in a Phase II proposal.

摘要 肩袖撕裂是成人肩部残疾的主要原因，造成30亿至120亿美元的损失 每年的医疗费用。肩袖修复(RCR)手术比非手术有更大的改善 选择。然而，RCR术后的康复需要仔细平衡运动以防止肩部僵硬。 同时保持肩部稳定，保护修复完整性。目前的早期康复涉及被动范围 在门诊理疗期间进行的运动锻炼。 ēLIZUR和匹兹堡大学共同提议开发Cufflink，这是一种用于RCR后的远程医疗系统 通过整合之前的两个成功的发展：机械加固和 稳定系统(SSS)和互动的远程监控能力(IA)。袖扣将有助于邮寄 RCR康复通过提供安全、可靠和在家中活动肩膀的方法，同时允许 远程监控。这减少了在康复早期阶段昂贵的住院治疗的需要，增加了 无障碍地照顾行动不便的病人和/或在农村地区，并增加沟通和 医生及其工作人员通过临床医生门户网站进行监督。 首先，德尔福将对整形外科医生和物理治疗师进行调查，以了解他们的 对当前RCR最佳做法的意见。同时，一个集成的移动监控应用程序 将根据专家达成的共识开发和完善编程接口 Delphi面板。这将导致SSS中来自定量运动传感器的原始数据信号的转换 转化为临床可接受的远程医疗准备数据流。然后，一个基于IA的移动医疗系统将被 发展起来的。这将包括一个为患者提供的应用程序套件和一个临床医生门户，它将提供运动反馈 给患者和临床医生，并允许临床医生监控患者数据并与患者接触。 然后，使用招募的一组RCR患者来验证袖扣的准确性和重测可靠性 主要通过UPMC整形外科诊所。袖扣的测量读数将与 一个黄金标准的光学运动捕捉系统，参与者将在几天后返回测试设施 重复这些练习。最后，袖扣在患者家中使用的可行性、可用性和可接受性 将会被评估。这些都将进行定量和定性的评估，预计结果将是 表现出高度的满意度。 该项目的成功完成将带来一种结合了机械运动安全性的装置 具有定量运动跟踪和远程监控的锻炼设备，以个性化和优化患者 以较低的成本从RCR手术中恢复。预计这种名为袖扣的设备将投入临床使用。 在第二阶段提案中进行评估。