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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Blood Flow Restriction
Other interventionExercise with restriction of blood flow supply
Brace
Other interventionKnee brace to restrict range of motion
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Brace and BFR exerciseExperimental treatment 2 interventions
Group B: Brace and BFR shamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Strength
Quadriceps strength using a hand held dynamometer
Time frame
Enrolment, week 2 and 4, end of intervention (12 weeks)Secondary outcomes
1
MRI
Time frame
Enrolment and end of intervention at 12 weeks2
Knee laxity
Knee arthrometer
Time frame
enrolment and end of intervention at 12 weeks3
Balance
Star execution test
Time frame
enrolment and end of intervention at 12 weeks4
Swelling
Knee circumference
Time frame
enrolment and end of intervention at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov