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临床试验/NCT03132987
NCT03132987已完成不适用

Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

Creighton University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Quadriceps Rate of Torque Development (RTD) Maximum

研究概览

简要总结

Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction

详细描述

A maximal isometric muscle contraction of the quadriceps will be used to examine neural and peripheral contributions to quadriceps strength. Neural influences will be quantified using the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group will be determined by examining the relationship with performance on jumping tasks and patient function (secondary outcomes).

The progressive strengthening program will be performed for 6 weeks and emphasize development of strength and power. Feasibility will be established if the researchers can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. The researchers will determine effect sizes for changes outcome measures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Physically active
  • History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only)

排除标准

  • History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care
  • Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament [MCL], posterior cruciate ligament[PCL]), chondral defects >2cm, fracture, bilateral knee injury
  • Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy
  • Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)

研究组 & 干预措施

Progressive strengthening program

Experimental

Subjects identified as having a clinically relevant strength deficit will be asked to participate in physical therapy sessions 3 times per week for 3 weeks. The strengthening program will consist of an individualized, progressive exercise program with an emphasis on increasing lower extremity strength, power, and biomechanics.

干预措施: Progressive strengthening program (Other)

结局指标

主要结局

Quadriceps Rate of Torque Development (RTD) Maximum

时间窗: Change from Baseline Quadriceps RTD at 3 weeks

slope of the torque-time tracing (change in torque/change in time) (Nm/kg\*s-1)

Knee Joint biomechanics during gait (nonlinear)

时间窗: Change from Baseline nonlinear knee joint biomechanics at 3 weeks

Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)

次要结局

  • Quadriceps percent activation(Change from Baseline Quadriceps percent activation at 3 weeks)
  • Knee Joint biomechanics during gait (traditional)(Change from Baseline knee joint biomechanics at 3 weeks)
  • Patient reported function(Change from Baseline IKDC at 3 weeks)
  • Jumping performance(Change from Baseline single leg hop for distance at 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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