Randomized Trial Comparing Blood Flow Restriction Exercise and Bracing for Complete ACL Tear Evaluating Benefits of Blood Flow Restriction Added to Standard Conservative Treatment in Adults Aged 18 to 40 with ACL Rupture

What this Trial Is About

Researchers are evaluating the effects of exercise combined with blood flow restriction BFR in patients who have a complete anterior cruciate ligament ACL rupture. This randomized clinical trial aims to determine if adding BFR provides extra benefits to the conservative treatment of ACL injuries and whether using a knee brace promotes spontaneous healing. The study compares two groups one receiving bracing combined with BFR exercise and the other receiving bracing with sham BFR, to understand the added value of BFR in managing ACL rupture. Participants in the intervention group will wear a knee brace for 6 weeks, with adjustments made in phases to gradually increase knee movement and weight bearing. They will follow a detailed exercise program that progresses through phases, starting with isometric contractions and advancing to resistance exercises and gait training, all performed under BFR except for some later exercises. The control group follows the same splinting and exercise plan but with sham BFR instead of real blood flow restriction. Both groups will continue home-based exercises monitored through an electronic platform that ensures proper execution and compliance. Throughout the study, participants will undergo initial assessments including MRI, strength tests, swelling measurement, knee laxity evaluation, pain scales, and functional scores. Strength, swelling, and pain will be reassessed during weeks 2 and 4, with a final evaluation at the end of the 12-week intervention including all initial measures. Compliance with the home exercise program will be tracked digitally. The main outcome measured is strength, with secondary outcomes including MRI changes, knee stability, balance, swelling, pain, and patient-reported outcomes. The trial follows a double-blind, randomized design to provide reliable data on the benefits of BFR in ACL rupture treatment.

Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"