Effect of Adding Blood Flow Restriction to Traditional Program After Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Quadriceps Muscle Strength
研究概览
简要总结
The goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR).
This study is conducted in male and female adults aged 18-35 years who underwent ACLR using a semitendinosus tendon autograft.
The main questions it aims to answer are:
Does adding BFR to a traditional rehabilitation protocol improve quadriceps and hamstring muscle strength after ACLR? Does adding BFR improve knee joint proprioception, range of motion, pain, and lower limb function after ACLR? Researchers compared a traditional rehabilitation protocol alone (control group) with the same protocol combined with blood flow restriction training (BFR group) to see if BFR provides superior improvements in postoperative outcomes.
Participants was: randomly assigned to either a traditional rehabilitation group or a BFR-assisted rehabilitation group Perform supervised rehabilitation exercises from the 2nd to the 12th postoperative week Undergo assessments of muscle strength, knee proprioception, range of motion, pain, and function Be evaluated 1 week before surgery and at 1.5 and 3 months after ACL reconstruction
详细描述
Anterior cruciate ligament reconstruction (ACLR) is commonly followed by persistent quadriceps and hamstring weakness, reduced knee range of motion, impaired proprioception, pain, and limitations in lower limb function despite standard rehabilitation. Traditional postoperative rehabilitation protocols may not fully restore neuromuscular performance within the early months following surgery.
Blood flow restriction (BFR) training has emerged as a rehabilitation strategy that allows low-load exercise to produce strength gains comparable to high-load training by partially restricting arterial inflow and venous outflow during exercise. This approach may be particularly beneficial in the early postoperative phase after ACLR, when high mechanical loading is contraindicated.
This randomized controlled clinical trial investigates the effects of adding BFR training to a traditional rehabilitation protocol following ACL reconstruction. Participants are randomly allocated to either a traditional rehabilitation protocol alone or the same protocol combined with BFR applied to the operated limb during exercise sessions. Rehabilitation is initiated in the early postoperative period and continues for a standardized duration.
Clinical outcomes related to muscle performance, knee joint function, proprioceptive accuracy, range of motion, and pain are evaluated at multiple time points before and after surgery to examine short-term and mid-term recovery patterns. The study aims to determine whether the inclusion of BFR enhances functional recovery compared with conventional rehabilitation alone following ACLR.
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
- Double (Participant, Outcomes Assessor)
盲法说明
patient and research assistant (the examiner of all patients) were blinded
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18-35 years Undergoing primary unilateral anterior cruciate ligament reconstruction Reconstruction performed using semitendinosus tendon autograft Referred for postoperative rehabilitation by an orthopedic surgeon Medically cleared to participate in postoperative rehabilitation and exercise training Ability to understand and follow verbal instructions Willingness to participate and provide written informed consent
排除标准
- •History of previous surgery on either knee Concomitant ligament injuries requiring surgical repair (e.g., PCL, MCL, LCL) Severe meniscal injury requiring repair or affecting rehabilitation progression Known cardiovascular, vascular, or thromboembolic disorders Peripheral vascular disease or conditions contraindicating blood flow restriction training Neurological disorders affecting lower limb function Uncontrolled systemic disease (e.g., uncontrolled diabetes or hypertension) Postoperative complications such as infection, deep vein thrombosis, or graft failure Inability to comply with the rehabilitation program or follow-up assessments
研究组 & 干预措施
Traditional Rehabilitation Protocol Group
Participants in this group received a standard postoperative rehabilitation program following anterior cruciate ligament reconstruction (ACLR) from the 2nd to the 12th postoperative week.
干预措施: traditional rehabilitation protocol (Other)
Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group
Participants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises.
干预措施: traditional rehabilitation protocol (Other)
Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group
Participants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises.
干预措施: Blood Flow Restriction (Device)
结局指标
主要结局
Quadriceps Muscle Strength
时间窗: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
Hamstring Muscle Strength
时间窗: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
次要结局
- Knee Joint Proprioception (Joint Position Sense)(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
- Knee Joint Range of Motion (ROM)(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
- Knee Joint Pain(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
- Lower Limb Function(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
研究者
Ahmed Mohamed Mahmoud Abdelaziz Khalil
doctor
Cairo University