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Interventions to Enhance Quadriceps Output After ACLR

2026年9月4日 更新者：University of Wisconsin, Madison

Clinical Interventions to Acutely Enhance Quadriceps Output After Anterior Cruciate Ligament Reconstruction

The investigators are interested in determining what treatments are effective in reducing inhibition after anterior cruciate ligament (ACL) surgery and helping people increase quadriceps strength. Two interventions that are often used clinically are neuromuscular electrical stimulation (NMES) and vibration. This is a study of how effective these treatments are, whether they work the same for everyone, and if one is better than the other. 22 participants will be enrolled and on study for 2 to 3 weeks.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

After a screening visit, participants will be randomized to 2 intervention conditions over 2, 60-minute visits at least 1 week apart where they will complete:

  • a 5 minute low intensity warm-up on a stationary bike
  • a series of patient-reported outcomes surveys
  • a pre-intervention quadriceps performance assessment

  • the intervention condition, one each visit, either:

    • ~20 minutes of NMES while completing rehabilitation exercises, OR
    • ~20 minutes of hamstring muscle vibration
  • a post-intervention quadriceps performance assessment

The primary objective of the study is to characterize the acute effects of interventions designed to mitigate the influence of inhibition (NMES and hamstrings muscle vibration) on quadriceps muscle performance in people post-anterior cruciate ligament reconstruction (ACLR) who have significant potential to benefit from these interventions (e.g. less than 4 months post-surgery).

  • Specific Aim 1: To determine the acute effects of quadriceps NMES and hamstrings muscle vibration on quadriceps muscle performance in people 2-4 months post-ACLR
  • Specific Aim 2: To determine if individuals with signs of more pronounced neural inhibition (quantified via assessment of knee extensor torque steadiness) have greater responses to NMES and hamstrings muscle vibration

Hypothesis 1: Quadriceps muscle strength will increase in people 2-4 months post-ACLR after 20 minutes of quadriceps NMES or hamstrings muscle vibration. The magnitude of increase in strength will be similar for both interventions.

Hypothesis 2: Surgical limb knee extensor torque steadiness will be strongly positively correlated with changes in quadriceps strength after NMES or hamstrings muscle vibration. People with greater steadiness impairments will demonstrate greater acute increases in quadriceps strength.

研究类型

介入性

注册 (估计的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Wisconsin
      • Madison、Wisconsin、美国、53706
        • 招聘中
        • UW Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Have undergone ACLR within the previous 4 months
  • Are at least 2 months post-ACLR

Exclusion Criteria:

  • A history of ACLR on both legs

  • Since the most recent ACLR:

    • secondary lower extremity surgery
    • leg or foot fracture
  • Unable to walk without an assistive device
  • Pain of greater than 5/10 during quadriceps strengthening exercises with the surgical limb
  • Cannot achieve 90 degrees of knee flexion with the surgical limb
  • People with contraindications to NMES
  • Anyone who had a previous skin reaction to NMES or attempted but could not tolerate NMES
  • Peripheral neuropathy or other neurological conditions

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：NMES then Vibration
设备：NMES
The thigh of the surgical leg will be cleaned with isopropyl alcohol. 2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles. An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb. Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch. Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes).
其他名称：
  • Empi Continuum
设备：Vibration
Participants will sit in a comfortable position on a treatment plinth with knees flexed to ~30°, hips flexed between 30-60°, and the back supported. The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA). Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of ~6 mm.
其他名称：
  • Thumper Versa Pro
实验性的：Vibration then NMES
设备：NMES
The thigh of the surgical leg will be cleaned with isopropyl alcohol. 2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles. An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb. Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch. Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes).
其他名称：
  • Empi Continuum
设备：Vibration
Participants will sit in a comfortable position on a treatment plinth with knees flexed to ~30°, hips flexed between 30-60°, and the back supported. The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA). Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of ~6 mm.
其他名称：
  • Thumper Versa Pro

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change in knee extensor peak torque production
大体时间：measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

次要结果测量

结果测量
大体时间
Change in knee extensor torque steadiness
大体时间：measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Wisconsin, Madison

调查人员

  • 首席研究员：Daniel Cobian, DPT, PhD、University of Wisconsin, Madison

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026-0153
  • Protocol Version 10/24/25 (其他标识符：UW Madison)
  • SMPH | Ortho and Rehab (其他标识符：UW Madison)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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