Clinical trial NCT06762392: Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
Official title: Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
Keywords: Physical Therapy
Rehabilitation
Anterior Cruciate Ligament
Blood Flow Restriction
Randomized Clinical Trial
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: From baseline to the end of the intervention at 24 weeks
measure: Strength
timeFrame: From baseline to the end of the intervention at 24 weeks
measure: Range of Motion
timeFrame: From baseline to the end of the intervention at 24 weeks
Secondary outcomes:
measure: Kinesiophobia
timeFrame: From baseline to the end of the intervention at 24 weeks
measure: Patient's Quality of Life
timeFrame: From baseline to the end of the intervention at 24 weeks
measure: Functional Performance
timeFrame: From baseline to the end of the intervention at 24 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
Study officials:
References: