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

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation

• Registration Number: NCT06762392
• Lead Sponsor: University of Valencia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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	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	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

Secondary Outcome Measures

Name	Time	Method
Kinesiophobia	From baseline to the end of the intervention at 24 weeks	Kinesiophobia, or the fear of movement due to pain or injury-related concerns, will be assessed using the Tampa Scale for Kinesiophobia-11 (TSK-11), a validated self-reported questionnaire. The TSK-11 consists of 11 items that evaluate fear-avoidance beliefs related to movement and physical activity. Participants rate their level of agreement with each statement on a Likert scale, generating a total score that reflects the severity of movement-related fear.
Patient's Quality of Life	From baseline to the end of the intervention at 24 weeks	Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12), a validated self-reported questionnaire that measures physical and mental health status. The SF-12 evaluates key domains such as physical functioning, pain, general health perceptions, vitality, social functioning, emotional well-being, and mental health. Scores are calculated to generate composite measures of physical and mental health, allowing for the assessment of overall well-being and the impact of the intervention on participants' quality of life
Functional Performance	From baseline to the end of the intervention at 24 weeks	Functional performance will be assessed through a series of validated physical tests designed to evaluate lower limb strength, endurance, and neuromuscular control. Participants will complete the following tests (1) Single Heel Rise (Step Test): The participant stands on one leg on a step and performs repeated heel raises until fatigue or failure to maintain proper form. This test assesses calf muscle endurance and strength (2) Single Leg Bridge: The participant lies supine with their heel positioned 60 cm above the floor and performs repeated single-leg hip bridges. This test evaluates posterior chain strength, particularly in the gluteal and hamstring muscles (3) Single Leg Squat: The participant performs a squat on one leg, aiming to reach 60° of knee flexion while maintaining balance and proper form. This test measures lower limb strength, stability, and motor control.

Trial Locations

Locations (1)

Faculty of Physiotherapy; 🇪🇸 Valencia, Spain