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: 10463736
• 负责人: Thomas S Buchanan
• 金额: $ 41.76万
• 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 2024-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10463736
• 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 前交叉韧带（ACL）撕裂是最常见的膝关节损伤之一， 发生在动态的足部-地面相互作用期间。ACL重建手术与物理 治疗是护理的标准。然而，即使经过康复治疗，再次受伤的风险也很高 恢复完全无限制活动（RTA）。这是因为， 评估RTA的康复和标准没有标准化，无法评估 腿的神经肌肉控制（即，腿部灵活性）。目前对腿部灵活性的测试并不 定量的，并且通常是有风险的，因为它们需要执行动态承重动作。 此外，神经肌肉控制在性别之间存在差异，女性的风险要高出6 - 10倍。 ACL损伤没有测试可以量化腿灵活性简单和安全的门诊 以确定妇女和男子是否准备好RTA。Neuromuscular Dynamics，LLC（NMD） 开发了腿部版本的Valero Dexterity Test ™。它有效地量化了 神经肌肉系统控制动态的脚-地面相互作用而不暴露患者 到大的力量或全重量轴承演习。它可以检测神经肌肉控制的缺陷， 性别差异，并告知康复策略和RTA准备。在第一阶段，我们 开发了便携式电池驱动的腿部灵活性测试设备，改进了平板电脑的UI/UX， 部署了云计算平台。我们还生产了医用级压缩 弹簧、已确定的报销代码和该I类产品的监管路径，FDA 510（k） 豁免装置我们还证明了腿部灵活性测试可以 测量腿部灵活性，并证实了患者在 正在接受RTA该系统被临床医生热情采用，并被评为 优秀的可用性评分。此外，我们证明了实施单一IRB的能力 4个临床中心的方案。第二阶段将优化制造和云计算， 评估并证明腿部灵活性测试的临床疗效，以告知康复和改善 RTA决策。目标1：优化制造和固件。目标2：平板电脑 软件将得到改进。目标3：软件即服务和云计算将成为 实现自动分析和数据显示，以生成报告。目标4：3年 纵向研究将跟踪ACL损伤患者，直至清除和试验对照 受试者建立健康水平的腿部灵活性，以告知清除率并确定 复苏这些目标将开发一个商业化的腿部灵活性测试， 证明其在优化康复和告知RTA决策方面的有效性。