Clinical Interventions to Acutely Enhance Quadriceps Output After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in knee extensor peak torque production
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have undergone ACLR within the previous 4 months
- •Are at least 2 months post-ACLR
排除标准
- •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
研究组 & 干预措施
Vibration then NMES
干预措施: NMES (Device)
Vibration then NMES
干预措施: Vibration (Device)
NMES then Vibration
干预措施: NMES (Device)
NMES then Vibration
干预措施: Vibration (Device)
结局指标
主要结局
Change in knee extensor peak torque production
时间窗: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
次要结局
- Change in knee extensor torque steadiness(measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks)