Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorEuropean University Cyprus
About this trial
The goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture.
The main questions it aims to answer are:
1. Does blood flow restriction adds any additional benefits to conservative treatment of the ACL? 2. Does bracing promotes spontaneous healing to the ACL
Researchers will compare bracing and BFR to bracing and sham BFR to see if the intervention provides any additional benefits to the conservative management of this injury.
Participants will:
1. Use a knee brace for 6 weeks with adjustments according to protocol 2. Follow and identical exercise plan with either BFR (intervention group) or BFR sham (control group) 3. Follow a home based exercise program.
Eligibility criteria
Qualifiers
MRI-confirmed complete rupture of ACL. Ability to communicate and read fluently in Greek and be willing to keep their leg immobilised for the required period based on the study protocol.
Disqualifiers
Heart disease, overweight, diabetes, pregnancy, thrombophilia, atrial fibrillation, heart failure, cancer, use of drugs that may increase blood clotting, use of hormones or contraceptives, any reason for not using BFR e.g., an open wound or serious skin problems and/or allergies to the cuff material.
Trial design
Treatments tested in this trial
- Blood Flow Restriction
- Brace
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov