Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
概览
- 阶段
- 不适用
- 干预措施
- Standard Rehabilitation
- 疾病 / 适应症
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- 发起方
- University of Valencia
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain Intensity
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery.
The main questions it aims to answer are:
Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone?
Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery?
Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.
详细描述
Anterior Cruciate Ligament (ACL) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. Despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role. This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely. The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.
研究者
Borja Pérez-Domínguez
Assistant Professor
University of Valencia
入排标准
入选标准
- •Patients aged between 18 and 45 years.
- •Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery
排除标准
- •Cardiovascular comorbidities
- •Severe metabolic disorders or postoperative complications
- •Previous joint disorders requiring surgery on the affected leg
- •Pregnancy
- •Coagulation disorders
研究组 & 干预措施
Standard Rehabilitation
Participants in this group will receive a standardized post-operative rehabilitation protocol specifically designed for ACL reconstruction recovery. The protocol includes progressive exercises tailored to the recovery phases: early recovery (Phase 1), strength and neuromuscular control (Phase 2), agility and landing mechanics (Phase 3), and return to sport (Phase 4). Sessions will be supervised weekly by trained Physical Therapists, with additional unsupervised exercises to be performed at home or in the gym. This protocol follows current evidence-based guidelines without the incorporation of blood flow restriction therapy
干预措施: Standard Rehabilitation
Standard Rehabilitation + Blood Flow Restriction
Participants in this group will follow the same standardized post-operative rehabilitation protocol as the Active Comparator group, tailored to the recovery phases for ACL reconstruction (Phases 1-4). In addition, during Phase 2 (weeks 2-12), participants will undergo blood flow restriction (BFR) therapy during specific strengthening exercises. The BFR intervention involves applying a pneumatic cuff to the proximal thigh to achieve 70-80% arterial occlusion, combined with low-intensity resistance exercises (15-20% of 1RM). This approach aims to enhance muscle strength and recovery while minimizing joint stress. Sessions will be supervised weekly by trained Phyisical Therapists.
干预措施: Blood Flow Restriction
结局指标
主要结局
Pain Intensity
时间窗: From baseline to the end of the intervention at 24 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS), a self-reported measure where the participant marks their perceived pain on a 100mm line, with one end representing "no pain" and the other representing the "worst pain imaginable." The VAS provides a subjective measure of pain intensity, enabling the tracking of pain levels over time to evaluate the impact of the intervention on pain relief. This is a commonly used tool to gauge pain perception in both clinical and research settings.
Strength
时间窗: From baseline to the end of the intervention at 24 weeks
Strength will be assessed using handheld dynamometry, an objective measure of muscle force production. Participants will perform maximal voluntary contractions against the dynamometer, which quantifies force output in Newtons (N) or kilograms (kg). This method provides a reliable and valid measure of muscle strength, allowing for the evaluation of changes over time in response to the intervention.
Range of Motion
时间窗: From baseline to the end of the intervention at 24 weeks
Range of Motion (ROM) will be assessed using goniometry, a standardized method for measuring joint flexibility and movement capacity. A goniometer will be positioned at the joint of interest, and participants will perform active and/or passive movements while the angular displacement is recorded in degrees. This technique provides an objective measure of joint mobility, enabling the evaluation of changes over time in response to the intervention
次要结局
- Kinesiophobia(From baseline to the end of the intervention at 24 weeks)
- Patient's Quality of Life(From baseline to the end of the intervention at 24 weeks)
- Functional Performance(From baseline to the end of the intervention at 24 weeks)