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.
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
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.
- Conditions
- Anterior Cruciate Ligament Injuries
- 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 group | Role | What they receive |
|---|---|---|
| conventional physical therapy program | Sham comparator | participants 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 program | Experimental | participants 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.
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
knee functional test
will be assessed by the single leg hop test
Measured: after 3 months of intervention
balance
will be assessed by the Y balance test for the lower quarter
Measured: after 3 months of intervention
quadriceps and hamstring muscles strength
will be assessed by the hand held dynamometer
Measured: after 3 months of intervention
Secondary outcomes (2)
Thigh muscle girth
will be assessed by a non-elastic measuring tape
Measured: baseline then 3 months after intervention
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.
- First posted31 May 2024
- Study start31 May 2024
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Ali Abed, Cairo University
- Investigators
- Enas F Youssef, Professor, Study chair, Prof. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo UniversityDina S Abd Allah, lecturer, Study director, Lec. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo UniversityAhmed S Elkalyoby, Asst. prof, Study director, Asst. prof. of orthopedic surgery, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Blood Flow Restriction Technique and Conventional Physical Therapy After Anterior Cruciate Ligament Reconstruction: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06437470
- Acronym / sponsor ID
- P.T.REC/012/005176
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy program | Sham comparator | Other: blood flow restriction techniqueparticipants will receive the conventional physical therapy program while using non-inflated cuff as a sham treatment during exercising. |
| blood flow restriction combined to conventional physical therapy program | Experimental | Other: blood flow restriction techniqueparticipants will receive the conventional physical therapy program with the use of BFR cuff which will be inflated to reach 80% of limb occlusive pressure |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood flow restriction techniqueAll 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. | Other | blood flow restriction combined to conventional physical therapy program, conventional physical therapy program |
Primary outcome
knee function
Time frame: after 3 months of intervention
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.
knee functional test
Time frame: after 3 months of intervention
will be assessed by the single leg hop test
balance
Time frame: after 3 months of intervention
will be assessed by the Y balance test for the lower quarter
quadriceps and hamstring muscles strength
Time frame: after 3 months of intervention
will be assessed by the hand held dynamometer
2 secondary outcomes
Thigh muscle girth
Time frame: baseline then 3 months after intervention
Knee effusion
Time frame: baseline then 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas F Youssef, Professor study chair
Prof. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University
Dina S Abd Allah, lecturer study director
Lec. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University
Ahmed S Elkalyoby, Asst. prof study director
Asst. prof. of orthopedic surgery, Cairo University
1 site in 1 country: see every site and its status.
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.