Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial.
Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial.
复制标题
密歇根前十字韧带康复倡议 (MiACLR)：随机临床试验方案。
DOI：
10.1093/ptj/pzaa169
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发表时间：
2020
期刊：
影响因子：
3.2
通讯作者：
Palmieri-Smith,RiannM
中科院分区：
文献类型：
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作者：
Rodriguez,Kazandra;Garcia,StevenA;Spino,Cathie;Lepley,LindseyK;Pang,Yuxi;Wojtys,Edward;Bedi,Asheesh;Angelini,Mike;Ruffino,Bethany;Bolley,Tyler;Block,Corey;Kellum,Jessica;Swartout,Andrew;Palmieri-Smith,RiannM
前交叉韧带重建（ACLR）后恢复股四头肌肌力可以预防创伤后骨关节炎，该疾病影响了超过50%的ACLR膝关节。然而，我们对如何通过康复最大限度地提高肌肉力量的理解存在根本性的差距。神经功能缺损和肌肉萎缩是ACLR后肌无力的两种主要机制。高强度神经肌肉电刺激（NMES）和离心运动（ECC）已被证明是独立的目标，这些机制。如果连续交付，NMES和ECC可能能够显着提高强度恢复。本研究的目的是评估NMES与ECC相结合，以恢复股四头肌的力量和生物力学对称性和保持软骨健康的能力在9和18个月后ACLR.MethodsThis研究是一项随机，双盲，安慰剂对照，单中心的临床试验在密歇根大学进行。共纳入112名年龄在14岁至45岁之间的前交叉韧带断裂受试者。受试者将以1：1的比例随机分配至NMES联合ECC组或NMES安慰剂联合ECC安慰剂组。从术后10 - 14天开始，NMES或NMES安慰剂将每周给药2次，持续8周，随后将直接进行8周的ECC或ECC安慰剂给药，每周给药2次。协同主要终点是等速四头肌力量对称性从基线至9个月的变化和从基线至ACLR后18个月的变化。次要结果指标包括等长四头肌力量、四头肌激活、四头肌肌肉形态（横截面积），膝关节生物力学（矢状面膝关节角度和力矩），患者报告的功能指数，和软骨健康（磁共振成像上的T1ρ和T2弛豫时间图）这项研究的结果可能会确定一种干预措施，能够针对ACLR后挥之不去的股四头肌无力，从而防止病情恶化。ACLR后的软骨健康，从而潜在地改善该患者群体的功能。
ObjectiveRestoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may prevent the posttraumatic osteoarthritis that affects over 50% of knees with ACLR. However, a fundamental gap exists in our understanding of how to maximize muscle strength through rehabilitation. Neurological deficits and muscle atrophy are 2 of the leading mechanisms of muscle weakness after ACLR. High-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise (ECC) have been shown to independently target these mechanisms. If delivered in succession, NMES and then ECC may be able to significantly improve strength recovery. The objectives of this study were to evaluate the ability of NMES combined with ECC to restore quadriceps strength and biomechanical symmetry and maintain cartilage health at 9 and 18 months after ACLR.MethodsThis study is a randomized, double-blind, placebo-controlled, single-center clinical trial conducted at the University of Michigan. A total of 112 participants between the ages of 14 and 45 years and with an anterior cruciate ligament rupture will be included. Participants will be randomly assigned 1:1 to NMES combined with ECC or NMES placebo combined with ECC placebo. NMES or NMES placebo will be delivered 2 times per week for 8 weeks beginning 10 to 14 days postoperatively and will be directly followed by 8 weeks of ECC or ECC placebo delivered 2 times per week. The co-primary endpoints are change from baseline to 9 months and change from baseline to 18 months after ACLR in isokinetic quadriceps strength symmetry. Secondary outcome measures include isometric quadriceps strength, quadriceps activation, quadriceps muscle morphology (cross-sectional area), knee biomechanics (sagittal plane knee angles and moments), indexes of patient-reported function, and cartilage health (T1ρ and T2 relaxation time mapping on magnetic resonance imaging).ImpactThe findings from this study might identify an intervention capable of targeting the lingering quadriceps weakness after ACLR and in turn prevent deterioration in cartilage health after ACLR, thereby potentially improving function in this patient population.