NCT04302558已完成不适用
Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in muscle diameter (hypertrophy)
研究概览
简要总结
Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between 13 and 40 years old
- •Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
- •Subjects must be able to understand study procedures and comply with them for the entire duration of the study
- •Subjects must have normal contralateral limb strength
排除标准
- •Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
- •Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
- •Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
- •Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent
结局指标
主要结局
Change in muscle diameter (hypertrophy)
时间窗: 2 weeks pre-operative, 8-10 days post-operative
Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris
次要结局
- Change in muscle strength(2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative)
研究者
Anikar Chhabra
Principal Investigator
Mayo Clinic
研究点 (2)
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