AzTrials
AzTrials

Anterior Cruciate Ligament InjuriesNCT06437470

Effect of Blood Flow Restriction Technique After Anterior Cruciate Ligament Reconstruction

A study testing blood flow restriction technique in people with Anterior Cruciate Ligament Injuries, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study will be to evaluate the effect of adding BFR (using 80% of LOP) to the conventional physical therapy program on knee function, functional test, balance, quadriceps and hamstrings muscles strength, thigh muscle girth and knee effusion in rehabilitation after ACLR. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
blood flow restriction technique
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteEgypt
Study dates
31 May 2024to 29 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged from 18-35 years.
  • Underwent an ACLR semitendinosus autograft one-week post-operative
  • Willingness to participate in the intervention and subsequent assessment.
  • BMI from 18.5 to 29.9 kg/m2.

Who cannot join

  • Insecure graft fixation (due to bone quality, suspension).
  • Active infection.
  • Postsurgical excess knee swelling that may limit exercise performance.
  • ACLR using bone tendon bone (BTB) graft.
  • Any cardiovascular disease such as hypertension.
  • Any lower limb trauma.
  • Hip and ankle pathology.
  • BMI more than 30 kg/m2

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of physical therapy - Cairo University

    Cairo, Giza Governorate, 12613

Other trials in Egypt

About this study

Official title: Combined Effect of Blood Flow Restriction Technique and Conventional Physical Therapy After Anterior Cruciate Ligament Reconstruction: A Pilot Randomized Controlled Trial

The purpose of this study will be to evaluate the effect of adding BFR (using 80% of LOP) to the conventional physical therapy program on knee function, functional test, balance, quadriceps and hamstrings muscles strength, thigh muscle girth and knee effusion in rehabilitation after ACLR.

Read the detailed description

Anterior cruciate ligament (ACL) injury is one of the most common knee injuries especially in the age range 20 to 29 years. It is commonly seen during sport activities including jumping, pivoting or during contact with the other players (Khalil et al., 2023).

Quadriceps and hamstrings muscle weakness and atrophy are commonly seen after Anterior cruciate ligament reconstruction (ACLR) mainly due to weight bearing limitation in the early stage of rehabilitation (Barber-Westin and Noyes 2019 and Hughes et al., 2019). Recent rehabilitation protocols focused on range of motion (ROM) exercises and increased muscle activation in the early post-operative phase to minimize complications such as joint stiffness and muscle weakness (Myer et al., 2006 and Patterson et al., 2019a).

It is recommended by the American College of Sports Medicine to use 60% to 70% of one repetition maximum (1 RM) to increase muscle strength and 70% to 80% of 1 RM to increase muscle size. However, using these percentage of loads in the early post-operative phase after ACLR may not be applicable (Barber-Westin and Noyes 2019). Therefore, therapists considered it is necessary to find a safe exercise protocol designed to increase muscle strength and mass to be used in the early post-operative phase. One of these protocols is the blood flow restriction training (BFRT) (Patterson et al., 2019a).

The BFRT is a technique that restricts arterial and venous circulation in the working muscles during exercise (Scott et al., 2015). This technique uses a pneumatic tourniquet system that applies external pressure to the most proximal part of the arm or the thigh. Cuff inflation causes compression on the vascular structures under the cuff leading to occlusion of the venous return and restriction of the arterial blood flow to the distal part of the limb. This intentionally induced ischemic environment results in a state of hypoxia within the distal muscles (Manini and Clark 2009). In such environment, muscle strength and hypertrophy can be reached by smaller external loads such as 20% or 30% of 1RM (Loenneke et al., 2012a). This makes the BFRT applicable in the early post-operative phase of rehabilitation without stressing the knee joint, thus protecting the graft and minimizing the risk of increasing any associated injuries in cartilage or meniscus (Loenneke et al., 2012b and Arve et al., 2020).

The BFRT is beneficial for many groups such as geriatrics and those with degenerative joint diseases, ligamentous injury and inflammatory diseases (Hughes et al., 2017). Early BFRT research designs used general measures to calculate cuff pressures, such as setting pressure relative to systolic blood pressure, thigh circumference, or random pressures which is probably inaccurate especially with change in limb circumference or body position (Takano et al., 2005 and Loenneke et al., 2015). A study performed by (Khalil et al., 2023) used the portable doppler ultrasound device to calculate limb occlusion pressure (LOP) of dorsalis pedis artery while manually inflating the restriction cuff. This procedure is operator dependent and may lead to some errors, especially in determining the exact location of the artery.

Recent research recommends the use of individualized BFRT where the percentage of occlusion of the vascular structures is determined automatically for each individual separately (Scott et al., 2015).

Previous studies concluded that BFRT after ACLR was effective in improving knee extension and flexion torques, pain, and balance (Spada et al., 2022, Bobes et al., 2020 and Jung et al., 2022) A recent systematic review performed by (Colapietro et al., 2023) found that limited studies included functional testing of the knee joint after BFRT which will be covered in this study using the latest wireless version of AirBands produced by VALD performance company which possesses the ability to automatically calculate LOP for each participant alone as recommended by the guidelines of Australian Institute of Sport.

Up to the authors' knowledge, there was no study has investigated the effect of blood flow restriction (BFR) using 80% of LOP combined with the conventional physical therapy program on knee function and balance compared to the conventional physical therapy program alone after ACLR.

Being tested
blood flow restriction technique
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood flow restriction techniqueOther

    All participants in the control group will receive the conventional physical therapy program with the use non-inflated cuff as a sham treatment during exercising.

    All participants in the intervention group will receive the conventional physical therapy program combined to blood flow restriction to 80% of limb occlusive pressure by using blood flow restriction cuff.

Study groups in NCT06437470
Study groupRoleWhat they receive
conventional physical therapy programSham comparatorparticipants will receive the conventional physical therapy program while using non-inflated cuff as a sham treatment during exercising.
Receives: Other: blood flow restriction technique
blood flow restriction combined to conventional physical therapy programExperimentalparticipants will receive the conventional physical therapy program with the use of BFR cuff which will be inflated to reach 80% of limb occlusive pressure
Receives: Other: blood flow restriction technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. knee function

    will be assessed by the Arabic version of the knee outcome survey-activities for daily living scale.

    It encompasses six questions addressing restrictions in daily activities caused by symptoms like pain, swelling, and instability, and eight questions evaluating difficulties in functional tasks such as walking, stair climbing, and sitting or standing up from a chair.

    Each question is rated on a 6-point Likert scale.

    Scores range from 0 to 70, with higher scores indicating better functional capacity.

    Measured: after 3 months of intervention

  2. knee functional test

    will be assessed by the single leg hop test

    Measured: after 3 months of intervention

  3. balance

    will be assessed by the Y balance test for the lower quarter

    Measured: after 3 months of intervention

  4. quadriceps and hamstring muscles strength

    will be assessed by the hand held dynamometer

    Measured: after 3 months of intervention

Secondary outcomes (2)
  1. Thigh muscle girth

    will be assessed by a non-elastic measuring tape

    Measured: baseline then 3 months after intervention

  2. Knee effusion

    will be assessed by a non-elastic measuring tape

    Measured: baseline then 3 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2024
  2. Study start31 May 2024
  3. Primary completion29 Jul 2025
  4. Study completion29 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06437470
Sponsor's protocol ID
P.T.REC/012/005176
Status last verified
Apr 2026
First submitted
25 May 2024
Last updated
15 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing blood flow restriction technique in people with Anterior Cruciate Ligament Injuries, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

knee function (time frame: after 3 months of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in