A simple and quantitative clinical assessment of neuromuscular recovery after ACL injury

ACL 损伤后神经肌肉恢复的简单定量临床评估

• 批准号: 10261538
• 负责人: Thomas S Buchanan
• 金额: $ 45.08万
• 依托单位: NEUROMUSCULAR DYNAMICS, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-12 至 2023-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10261538
• 关键词: Adopted; Age; Android; Anterior Cruciate Ligament; Bar Codes; Bluetooth; COVID-19; Characteristics; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical assessments; Cloud Computing; Code; Computer software; Custom; Data; Data Display; Decision Making; Degenerative polyarthritis; Devices; Evolution; Generations; Goals; Health Insurance Portability and Accountability Act; Human; Industry Standard; Injections; Injury; Institutional Review Boards; Intellectual Property; Knee Injuries; Knee Osteoarthritis; Leg; Legal patent; Logistics; Longitudinal Studies; Measures; Medical; Methods; Molds; Operative Surgical Procedures; Outpatients; Participant; Patients; Performance; Phase; Physical therapy; Preparation; Prevention; Production; Protocols documentation; Publications; Readiness; Reconstructive Surgical Procedures; Recovery; Rehabilitation therapy; Reporting; Risk; Risk Factors; Sex Differences; Site; Small Business Innovation Research Grant; Soldier; Source; System; Tablet Computer; Tablets; Technology; Testing; Time; Weight-Bearing state; Woman; anterior cruciate ligament injury; anterior cruciate ligament reconstruction; anterior cruciate ligament rupture; automated analysis; clinical center; clinical efficacy; commercialization; computational platform; cost; data management; design; dexterity; early onset; foot; high risk; improved; men; modifiable risk; neuromuscular; neuromuscular system; portability; printed circuit board; rehabilitation strategy; research and development; return to sport; scale up; sex; software as a service; standard of care; tool; usability

PROJECT ABSTRACT Anterior cruciate ligament (ACL) tears are one of the most common knee injuries and often occur during dynamic foot-ground interactions. ACL reconstructive surgery paired with physical therapy is the standard of care. However, there is a high risk of re-injury even after rehabilitation and clearance to return to full unrestricted activity (RTA). This is because methods of rehabilitation and criteria to evaluate RTA are not standardized to evaluate deficiency in neuromuscular control of the leg (i.e., leg dexterity). Current tests for leg dexterity are not quantitative and are often risky as they require performing dynamic weight-bearing maneuvers. Also, neuromuscular control differs between sexes, and women have a 6-10 times greater risk of ACL injury. There is no test that can quantify leg dexterity simply and safely in the outpatient setting to determine RTA readiness in women and men. Neuromuscular Dynamics, LLC (NMD) developed the leg version of the Valero Dexterity Test™. It effectively quantifies the neuromuscular system control of dynamic foot-ground interactions without exposing the patient to large forces or full-weight bearing maneuvers. It can detect deficits in neuromuscular control, sex differences in it, and inform rehabilitation strategies and RTA readiness. In Phase I we developed a portable, battery-operated Leg Dexterity Test device, improved tablet UI/UX, and deployed a cloud-computing platform. We also manufactured medical grade compression springs, identified reimbursement codes and the regulatory path for this Class I, FDA 510(k) exempt device. We also demonstrated proof-of-concept that the Leg Dexterity Test can measure leg dexterity and confirmed the hypothesis that patients have disrupted dexterity after being cleared for RTA. The system was enthusiastically adopted by clinicians and rated as excellent in Usability Score. Moreover, we demonstrated ability to implement a single IRB protocol across 4 clinical centers. Phase II will optimize manufacturing and cloud computing at scale and demonstrate clinical efficacy of Leg Dexterity Test to inform rehabilitation and improve RTA decision making. Aim 1: Manufacturing and firmware will be optimized. In Aim 2: Tablet software will be improved. Aim 3: Software-as-a-service and cloud computing will be implemented to automate analytics and data display for report generation. Aim 4: A 3-year longitudinal study will follow patients from ACL injury through clearance, and test control subjects to establish healthy levels of leg dexterity to inform clearance and to determine rates of recovery. These Aims will develop a commercialization-ready Leg Dexterity Test and demonstrate its efficacy in optimizing rehabilitation and informing RTA decisions.

项目摘要 前十字韧带(ACL)撕裂是最常见的膝关节损伤之一，通常 发生在动态的脚-地相互作用期间。前交叉韧带重建手术配合物理治疗 治疗是护理的标准。然而，即使在康复后，再次受伤的风险也很高。 以及恢复完全不受限制的活动(RTA)的许可。这是因为 康复和评估RTA的标准没有标准化来评估缺陷 腿部的神经肌肉控制(即腿部灵巧性)。目前的腿部灵巧性测试并不是 由于它们需要进行动态负重动作，因此往往是定量的，往往是有风险的。 此外，神经肌肉控制在性别之间也不同，女性的风险是男性的6-10倍 前交叉韧带损伤。没有一种测试可以简单而安全地量化门诊患者的腿部灵活性。 设置以确定女性和男性的RTA准备情况。神经肌肉动力学有限责任公司(NMD) 开发了腿部版本的瓦莱罗灵巧度测试™。它有效地量化了 不暴露患者的动态足-地相互作用的神经肌肉系统控制 到大的力量或满重的承重动作。它可以检测神经肌肉控制的缺陷， 性别差异，并提供康复策略和RTA准备情况。在第一阶段，我们 开发了便携式、电池供电的腿部灵巧性测试设备，改进了平板电脑UI/UX，以及 部署了云计算平台。我们还制造了医用级压力机 弹簧、已确定的报销代码和此I类的监管路径，FDA 510(K) 豁免设备。我们还演示了概念证明，腿部灵巧性测试可以 测量腿部灵活性，并证实了患者在手术后失去灵活性的假设 正在为区域运输协会放行。该系统被临床医生热情采用，并被评为 易用性得分极高。此外，我们还展示了实现单一IRB的能力 四个临床中心的协议。第二阶段将优化制造业和云计算 评测和展示腿部灵巧性测试的临床效果，为康复和改善提供信息 RTA决策制定。目标1：制造和固件将得到优化。目标2：平板电脑 软件将会得到改进。目标3：软件即服务和云计算将 实施以自动执行分析和数据显示以生成报告。目标4：为期3年 纵向研究将跟踪患者从前交叉韧带损伤到清除，并进行测试对照 受试者建立健康的腿部灵巧度水平，以告知清除情况并确定 恢复。这些目标将开发一种商业化准备的腿部灵活性测试和 展示其在优化康复和为区域TA决策提供信息方面的有效性。