Blood Flow Restriction in ACL Reconstruction Rehabilitation: A Double-Blinded RCT (NCT07406763) | Clinical Trial Compass
CompletedNot Applicable
Blood Flow Restriction in ACL Reconstruction Rehabilitation: A Double-Blinded RCT
Egypt36 participantsStarted 2020-02-01
Plain-language summary
The goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR).
This study is conducted in male and female adults aged 18-35 years who underwent ACLR using a semitendinosus tendon autograft.
The main questions it aims to answer are:
Does adding BFR to a traditional rehabilitation protocol improve quadriceps and hamstring muscle strength after ACLR? Does adding BFR improve knee joint proprioception, range of motion, pain, and lower limb function after ACLR? Researchers compared a traditional rehabilitation protocol alone (control group) with the same protocol combined with blood flow restriction training (BFR group) to see if BFR provides superior improvements in postoperative outcomes.
Participants was: randomly assigned to either a traditional rehabilitation group or a BFR-assisted rehabilitation group Perform supervised rehabilitation exercises from the 2nd to the 12th postoperative week Undergo assessments of muscle strength, knee proprioception, range of motion, pain, and function Be evaluated 1 week before surgery and at 1.5 and 3 months after ACL reconstruction
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Male or female participants aged 18-35 years Undergoing primary unilateral anterior cruciate ligament reconstruction Reconstruction performed using semitendinosus tendon autograft Referred for postoperative rehabilitation by an orthopedic surgeon Medically cleared to participate in postoperative rehabilitation and exercise training Ability to understand and follow verbal instructions Willingness to participate and provide written informed consent Exclusion Criteria History of previous surgery on either knee Concomitant ligament injuries requiring surgical repair (e.g., PCL, MCL, LCL) Severe meniscal injury requiring repair or affecting rehabilitation progression Known cardiovascular, vascular, or thromboembolic disorders Peripheral vascular disease or conditions contraindicating blood flow restriction training Neurological disorders affecting lower limb function Uncontrolled systemic disease (e.g., uncontrolled diabetes or hypertension) Postoperative complications such as infection, deep vein thrombosis, or graft failure Inability to comply with the rehabilitation program or follow-up assessments
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quadriceps Muscle Strength
Timeframe: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
2
Hamstring Muscle Strength
Timeframe: preoperative baseline, 1.5 months post-operative, and 3 months post-operative