Anterior Cruciate Ligament (ACL), Blood Flow Restriction Therapy
Conditions
Keywords
ACLR, BFRT
Brief 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
Detailed description
Anterior cruciate ligament reconstruction (ACLR) is commonly followed by persistent quadriceps and hamstring weakness, reduced knee range of motion, impaired proprioception, pain, and limitations in lower limb function despite standard rehabilitation. Traditional postoperative rehabilitation protocols may not fully restore neuromuscular performance within the early months following surgery. Blood flow restriction (BFR) training has emerged as a rehabilitation strategy that allows low-load exercise to produce strength gains comparable to high-load training by partially restricting arterial inflow and venous outflow during exercise. This approach may be particularly beneficial in the early postoperative phase after ACLR, when high mechanical loading is contraindicated. This randomized controlled clinical trial investigates the effects of adding BFR training to a traditional rehabilitation protocol following ACL reconstruction. Participants are randomly allocated to either a traditional rehabilitation protocol alone or the same protocol combined with BFR applied to the operated limb during exercise sessions. Rehabilitation is initiated in the early postoperative period and continues for a standardized duration. Clinical outcomes related to muscle performance, knee joint function, proprioceptive accuracy, range of motion, and pain are evaluated at multiple time points before and after surgery to examine short-term and mid-term recovery patterns. The study aims to determine whether the inclusion of BFR enhances functional recovery compared with conventional rehabilitation alone following ACLR.
Interventions
The traditional rehabilitation protocol includes progressive therapeutic exercises aimed at restoring: Quadriceps and hamstring muscle strength Knee joint range of motion Neuromuscular control and functional performance
DEVICEBlood Flow Restriction
Blood flow restriction was applied to the proximal thigh of the operated limb using a specially designed sphygmomanometer cuff capable of partially restricting arterial inflow and venous outflow during exercise. BFR was used during low-load resistance exercises targeting the quadriceps and hamstring muscles, in accordance with postoperative safety guidelines.
Sponsors
Ahmed Mohamed Mahmoud Abdelaziz Khalil
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
patient and research assistant (the examiner of all patients) were blinded
Intervention model description
Double-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Strength | preoperative baseline, 1.5 months post-operative, and 3 months post-operative | Assessed using a handheld dynamometer (HHD) Measured on the operated limb |
| Hamstring Muscle Strength | preoperative baseline, 1.5 months post-operative, and 3 months post-operative | Assessed using a handheld dynamometer (HHD) Measured on the operated limb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Joint Proprioception (Joint Position Sense) | preoperative baseline, 1.5 months post-operative, and 3 months post-operative | Assessed using a digital inclinometer Evaluated as joint position sense accuracy |
| Knee Joint Range of Motion (ROM) | preoperative baseline, 1.5 months post-operative, and 3 months post-operative | Flexion and extension measured using a digital goniometer |
| Knee Joint Pain | preoperative baseline, 1.5 months post-operative, and 3 months post-operative | Assessed using the Visual Analog Scale (VAS) |
| Lower Limb Function | preoperative baseline, 1.5 months post-operative, and 3 months post-operative | Assessed using the Arabic version of the Lower Extremity Functional Scale (LEFS) |
Countries
Egypt
Contacts
STUDY_DIRECTORMaha Mohammed, A.Prof
Cairo University
Outcome results
None listed