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Completed

NCT Number: NCT07406763

Blood Flow Restriction in ACL Reconstruction Rehabilitation: A Double-Blinded RCT

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Cairo, Cairo Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional rehabilitation protocol

Other

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

Blood Flow Restriction

Device

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.

Primary outcomes

  1. 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

  2. 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

  1. Knee Joint Proprioception (Joint Position Sense)

    Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative

    Assessed using a digital inclinometer Evaluated as joint position sense accuracy

  2. Knee Joint Range of Motion (ROM)

    Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative

    Flexion and extension measured using a digital goniometer

  3. Knee Joint Pain

    Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative

    Assessed using the Visual Analog Scale (VAS)

  4. Lower Limb Function

    Time frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative

    Assessed using the Arabic version of the Lower Extremity Functional Scale (LEFS)

Sponsors and collaborators

Lead sponsor

Ahmed Mohamed Mahmoud Abdelaziz Khalil

Other

Collaborators

  • Cairo University

Registry information

Official study title

Effect of Adding Blood Flow Restriction to Traditional Program After Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial

Acronym: *BFR*

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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