Effect of Adding Blood Flow Restriction to Traditional Program After Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ahmed Mohamed Mahmoud Abdelaziz Khalil
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Quadriceps Muscle Strength
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
patient and research assistant (the examiner of all patients) were blinded
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Traditional Rehabilitation Protocol Group
Participants in this group received a standard postoperative rehabilitation program following anterior cruciate ligament reconstruction (ACLR) from the 2nd to the 12th postoperative week.
Intervention: traditional rehabilitation protocol (Other)
Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group
Participants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises.
Intervention: traditional rehabilitation protocol (Other)
Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group
Participants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises.
Intervention: Blood Flow Restriction (Device)
Outcomes
Primary Outcomes
Quadriceps Muscle Strength
Time Frame: 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
Time Frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Assessed using a handheld dynamometer (HHD) Measured on the operated limb
Secondary Outcomes
- Knee Joint Proprioception (Joint Position Sense)(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
- Knee Joint Range of Motion (ROM)(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
- Knee Joint Pain(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
- Lower Limb Function(preoperative baseline, 1.5 months post-operative, and 3 months post-operative)
Investigators
Ahmed Mohamed Mahmoud Abdelaziz Khalil
doctor
Cairo University