Blood Flow Restriction in ACL Reconstruction Rehabilitation: A Double-Blinded RCT (*BFR*)

February 6, 2026 updated by: Ahmed Mohamed Mahmoud Abdelaziz Khalil

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Physical Therapy
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11511
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: traditional rehabilitation protocol

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
Experimental: 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.
Other: traditional rehabilitation protocol

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

Device: Blood 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative baseline, 1.5 months post-operative, and 3 months post-operative
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
preoperative baseline, 1.5 months post-operative, and 3 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative baseline, 1.5 months post-operative, and 3 months post-operative
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
preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Knee Joint Pain
Time Frame: preoperative baseline, 1.5 months post-operative, and 3 months post-operative
Assessed using the Visual Analog Scale (VAS)
preoperative baseline, 1.5 months post-operative, and 3 months post-operative
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)
preoperative baseline, 1.5 months post-operative, and 3 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Mohamed Mahmoud Abdelaziz Khalil

Collaborators

Cairo University

Investigators

  • Study Director: Maha Mohammed, A.Prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not applicable - the thesis does not describe a plan to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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