Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.

University of Valencia

Status: Enrolling

Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation

Treatments: Other: Standard Rehabilitation; Other: Blood Flow Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT06762392

UV-INV_ETICA-3498956

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 45 years.
• Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery

Exclusion criteria

• Cardiovascular comorbidities
• Severe metabolic disorders or postoperative complications
• Previous joint disorders requiring surgery on the affected leg
• Pregnancy
• Coagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Standard Rehabilitation

Active Comparator group

Description:

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

Treatment:

Other: Standard Rehabilitation

Standard Rehabilitation + Blood Flow Restriction

Experimental group

Description:

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.

Treatment:

Other: Blood Flow Restriction