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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Faculty of Physiotherapy
Valencia, Valencia, Spain
Start Date
January 1, 2025
Primary Completion Date
December 30, 2026
Completion Date
January 1, 2027
Last Updated
March 5, 2026
40
ESTIMATED participants
Blood Flow Restriction
OTHER
Standard Rehabilitation
OTHER
Lead Sponsor
University of Valencia
NCT07485530
NCT06818201
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07128602