MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

MiACLR：密歇根前十字韧带康复倡议

基本信息

批准号：
9761551
负责人：
Riann Marie Palmieri-Smith
金额：
$ 62.21万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-01 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9761551
关键词：
Affect Anterior Cruciate Ligament Atrophic Biomechanics Cartilage Cartilage Matrix Clinical Trials Contracts Contralateral Data Degenerative polyarthritis Development Diagnostic radiologic examination Documentation Double-Blind Method Environment Evidence based treatment Exercise Failure Future Genetic Growth Health Human Individual Injury International Intervention Intervention Studies Joints Knee Knee Osteoarthritis Knowledge Lead Limb structure Magnetic Resonance Imaging Measures Mechanical Stress Mechanics Medial Michigan Mission Morphology Motor Neurons Muscle Muscle Weakness Muscle function Neurologic Operative Surgical Procedures Pathway interactions Patient-Focused Outcomes Patients Physical Function Physical activity Placebos Postoperative Period Prevention approach Proteins Proteoglycan Quality of life Randomized Randomized Controlled Trials Recovery Reflex action Rehabilitation therapy Relaxation Research Risk Sample Size Side Societies Time Treatment Efficacy United States National Institutes of Health Visit Width Work anterior cruciate ligament reconstruction arm clinically significant cost density disability disabling disease driving force improved innovation life time cost ligament injury muscle strength neuromuscular stimulation patient stratification prevent primary outcome quadriceps muscle reconstruction rehabilitation paradigm rehabilitative care standard of care

项目摘要

ABSTRACT Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may help prevent the post-traumatic knee osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction. However, a fundamental gap exists in our understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. Our pilot work shows that when patients return to activity, quadriceps strength is ~70% of the uninjured side, which is far below the recommended 90%. Further, our data suggest that embedding high-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise into standard of care ACL rehabilitation leads to higher quadriceps strength when compared with standard of care alone. However, the true efficacy of these interventions is unknown, as we currently lack controlled trials with adequate sample sizes. The absence of this information serves as the driving force and focus of the proposed trial. Therefore, we propose a double- blind randomized controlled trial where ACLR patients will be randomized to 1 of 4 arms. Study arms will include: 1) 8 weeks of NMES+8 weeks of eccentric exercise; 2) 8 weeks of NMES placebo+8 weeks of eccentric exercise; 3) 8 weeks of NMES+8 weeks of eccentric placebo; and 4) 8 weeks of NMES placebo+8 weeks of eccentric placebo. All study arms will receive standard of care ACL rehabilitation in addition to the study interventions. We hypothesize that subjects receiving NMES+eccentric exercise (Arm 1) will realize greater improvements in strength and biomechanical function at 6 months following ACLR than patients in the other 3 study arms. Further, we anticipate that patients in the NMES+eccentric exercise arm (Arm 1) will best eliminate negative changes in cartilage health at 18 months following ACLR. This study is innovative, because it employs interventions that directly target the primary mechanisms that result in strength loss following ACLR and will also evaluate whether improving muscle strength can minimize early changes in cartilage health, which may be indicative of future osteoarthritis. The proposed research is significant because it will identify evidence-based treatment approaches that can successfully counteract the muscle weakness which plagues ACLR patients for years after injury and contributes to the onset of post-traumatic osteoarthritis.

抽象的恢复前交叉韧带重建后（ACLR）后恢复股四头肌强度可能有助于防止手术后10 - 20年影响膝盖以上50％以上的创伤后膝关节骨关节炎重建。但是，我们对如何最大化肌肉力量的理解存在基本差距在ACLR之后，由于当前的康复无法恢复对称的股四头肌强度。我们的飞行员工作表明，当患者重返活动时，股四头肌的强度约为未受伤的一侧的70％低于建议的90％。此外，我们的数据表明嵌入高强度神经肌肉电刺激（NME）和偏心运动进入护理标准ACL康复导致更高与仅护理标准相比，股四头肌的强度。但是，这些的真正功效干预措施尚不清楚，因为我们目前缺乏适当样本量的对照试验。没有该信息是拟议试验的推动力和重点。因此，我们提出了双重盲随机对照试验，其中ACLR患者将被随机分为4个臂中的1个。学习武器会包括：1）8周NME+8周的偏心运动； 2）8周NMES安慰剂+8周偏心运动； 3）8周NME+8周的偏心安慰剂； 4）NMES安慰剂+8周8周怪异的安慰剂。除了研究干预措施。我们假设接受NMES+偏心运动的受试者（ARM 1）将意识到 ACLR后6个月的强度和生物力学功能的改善要比患者中的更大其他3个研究臂。此外，我们预计NMES+偏心运动臂（ARM 1）中的患者最好在ACLR后18个月，消除软骨健康的负面变化。这项研究具有创新性，因为它采用了直接针对主要机制的干预措施，这些机制导致ACLR后强度损失还将评估提高肌肉力量是否可以最大程度地减少软骨健康的早期变化，这可能表明未来的骨关节炎。拟议的研究很重要，因为它将确定循证治疗方法可以成功抵消骗局的肌肉无力受伤后多年的ACLR患者，并导致创伤后骨关节炎的发作。