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临床试验/NCT03626857
NCT03626857已完成不适用

MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

University of Michigan4 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2019年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
4
主要终点
Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index

研究概览

简要总结

This clinical trial evaluates interventions to maximize muscle function and improve cartilage health following anterior cruciate ligament reconstruction. Improving muscle function may improve patient outcomes, improve joint mechanics, and potentially serve as a prevention approach for post-traumatic knee osteoarthritis. Knee osteoarthritis (OA) is a disabling disease that carries a substantial burden to society and to the individual affected.

详细描述

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 current understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. The investigators 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, these 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 controlled trials with adequate sample sizes are currently lacking. The absence of this information serves as the driving force and focus of the proposed trial. Therefore, the investigators propose a double-blind randomized controlled trial where ACLR patients will be randomized to 1 of 2 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 placebo. All study arms will receive standard of care ACL rehabilitation in addition to the study interventions. The investigators 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 placebo study arm. Further, the investigators 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Acute, complete ACL rupture
  • ACL reconstruction with autograft
  • Scheduled to undergo ACLR at U of Michigan
  • Willingness to participate in testing and follow-up as outlined

排除标准

  • Previous surgery to either knee
  • Bony fracture accompanying ACL injury
  • Patients who experienced a knee dislocation
  • Female participants who are pregnant or planning pregnancy

结局指标

主要结局

Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index

时间窗: Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction)

Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100

9 Months Isokinetic Quadriceps Strength Limb Symmetry Index

时间窗: 9 months (9 months post-ACL reconstruction)

Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100

次要结局

  • Knee Flexion Angle at 9 Months(9 months post-ACL reconstruction)
  • Knee Flexion Moment at 9 Months(9 months post-ACL reconstruction)
  • Knee Flexion Angle at 18 Months(18 months post-ACL reconstruction)
  • Knee Flexion Moment at 18 Months(18 months post-ACL reconstruction)
  • T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage(18 months post-ACL reconstruction)
  • T2 Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage(18 months post-ACL reconstruction)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riann Palmieri-Smith

Associate Professor

University of Michigan

研究点 (4)

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