Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Maximal isometric strength of knee extensors
研究概览
简要总结
This study aims to evaluate the effectiveness of neuromuscular electrical stimulation with superimposed voluntary contraction (NMES+ group) compared to NMES without voluntary contraction (NMES group) during the initial month of rehabilitation post anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group. Both groups will follow an identical rehabilitation regimen in the first month after surgery, which includes interventions for symptom management, inflammation control, edema reduction, improved joint motion range, and restoration of muscle function.
All participants will undergo identical assessment protocols at four time points: pre-surgery evaluation, and assessments at 2, 15, and 30 days post-ACLR. The primary outcome of the study is the maximal isometric strength of knee extensors. Secondary outcomes encompass thigh muscle atrophy, self-reported functional impairments, knee pain, knee edema, joint range of motion, and quadriceps activation status.
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
- Single (Outcomes Assessor)
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
- •Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.
排除标准
- •Failure to attend the pre-surgery assessment session;
- •Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;
- •Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition.
结局指标
主要结局
Maximal isometric strength of knee extensors
时间窗: Before surgery and 30 days post-surgery.
Assessed by manual isometric dynamometry
次要结局
- Quadriceps activation status(Before surgery, and then at 2, 15, and 30 days post-surgery.)
- Knee edema(Before surgery, and then at 2, 15, and 30 days post-surgery.)
- Joint range of motion(Before surgery, and then at 2, 15, and 30 days post-surgery.)
- Self-reported functional impairments(Before surgery, and then at 2, 15, and 30 days post-surgery.)
- Muscle atrophy(Before surgery, and then at 2, 15, and 30 days post-surgery.)
- Knee pain(Before surgery, and then at 2, 15, and 30 days post-surgery.)
研究者
Bruno Manfredini Baroni
PhD
Federal University of Health Science of Porto Alegre