ACLNCT06727344
Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"
A study testing Blood Flow Restriction and Brace in people with ACL and ACL - Anterior Cruciate Ligament Rupture, run by European University Cyprus at 2 sites in Cyprus.
Trial summary
The goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL, ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Blood Flow Restriction and Brace
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesCyprus
- Study dates
- 1 Feb 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- MRI-confirmed complete rupture of ACL. Ability to communicate and read fluently in Greek and be willing to keep their leg immobilised for the required period based on the study protocol.
Who cannot join
- Heart disease, overweight, diabetes, pregnancy, thrombophilia, atrial fibrillation, heart failure, cancer, use of drugs that may increase blood clotting, use of hormones or contraceptives, any reason for not using BFR e.g., an open wound or serious skin problems and/or allergies to the cuff material.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus2 sites, 2 recruiting
- Recruiting
European University Cyprus
Nicosia, 2404
Marios Vryonides, Vice Vector, +35722713112, M.Vryonides@euc.ac.cy
- Recruiting
European University Cyprus
Nicosia, 2404
Marios Vryonides, Vice-Rector, 0035722713112, M.Vryonides@euc.ac.cy
Alexis Pitsillides, Phd candidate
About this study
Official title: Comparison of Conservative Treatment With Blood Flow Restriction With Standard Management in Total ACL Rupture. "Randomized Clinical Trial"
The goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture.
The main questions it aims to answer are:
Read more
- Does blood flow restriction adds any additional benefits to conservative treatment of the ACL?
- Does bracing promotes spontaneous healing to the ACL
Researchers will compare bracing and BFR to bracing and sham BFR to see if the intervention provides any additional benefits to the conservative management of this injury.
Participants will:
- Use a knee brace for 6 weeks with adjustments according to protocol
- Follow and identical exercise plan with either BFR (intervention group) or BFR sham (control group)
- Follow a home based exercise program.
Read the detailed description
Methodological design:
For the purposes of the present study, a double-blind, two-arm randomised clinical trial will be conducted. Participants in the intervention group will undergo and exercise protocol with the use of blood flow restriction (BFR). Participants in control group will follow the same exercise protocol but with sham BFR instead. Both groups will follow the same brace protocol.
Intervention group:
The intervention group will consist of people with a recent ACL tear who meet the eligibility criteria. Participants in this group will follow a splint use protocol. In particular, during the first 3 weeks (phase 1) a splint will be used with the knee immobilised at 90°, non-weight bearing walking with the use of walking aids according to age and mobility. During the 4th and 5th week (phase 2) the range of motion of the splint will be set to 60° to 90° and from 30° to 90° respectively. Walking will remain non-weight bearing. During the 6th week (phase 3) the degree of freedom of the splint will be placed at 0° allowing full flexion but preventing hyperextension of the joint. During this phase, partial bearing is allowed with the use of a walking aid. From the 7th week (phase 4) onwards the splint is removed and walking is done with no loading restrictions.
Regarding the exercise program, participants in this group, during phase 1, will perform isometric quadriceps and hamstring contractions guided by a visual stimulus from an electronic hand dynamometer. The exercise parameters will be 75 repetitions divided into 4 sets (30,15,15,15) at 30% of the 1st maximum of the opposite leg. During phase 2, the exercise protocol is maintained as phase 1 with the only differences that the exercises will be performed at 60 degrees too. Additionally, the "sliding" exercise will be added where the heel is dragged on the bed causing knee flexion as well as the skateboard sliding exercise from a seated position in the allowed range of motion. Exercise parameters remain the same for all exercises as previous phase. In the 3rd phase, single leg squats up to 45° are added. Exercise parameters remain the same. In the 4th phase, the exercise protocol changes. Subjects start at a stationary bike for 5 minutes (without BFR) and the quadriceps and hamstrings isometrics are replaced with resistance exercises for extension and knee flexion. Sliding and single-leg squats are performed at an increased range of flexion (up to 90°) and climbing a 30cm step is added. All exercise parameters remain the same as in the previous phases. During the last phase (5th) gait retraining on a treadmill for 5 minutes and Y balance exercise is added. Both of these exercises will be performed without BFR. The break between sets will be 30 seconds and between exercises 1 minute.
The exercise program of the intervention group will be performed under lower extremity blood flow restriction. Cuff pressure will be reduced during the breaks. The execution speed of the exercises will be 2 seconds of contraction followed by 2 seconds of return. Hold in all isometric exercises will be 3 seconds.
Initial measurements will be taken upon enrollment of participants and will include MRI, Lachman test, arthrometer, strength, swelling, Lysholm scale, Tegner scale, pain (Vas), exercise pain (Vas). By the end of 2nd and 4th week, strength, swelling and pain (Vas) will be reassessed. The final measurements will be taken at the end of the intervention period and will include all the measurements taken initially.
The participants will be given a home-base exercise program through an electronic platform which will provide the possibility of monitoring their compliance. At the same time, through the platform, the correct execution of the exercises will be ensured as all the exercises will be presented with videos and specific exercise parameters.
Control Group:
The control group will perform an identical program of splinting, exercises, home exercises and measurements as the intervention group. The blood flow restriction protocol will be performed in an identical manner to the intervention group, with only difference being that variables setting will be set at a control program (sham).
- Conditions
- ACL, ACL - Anterior Cruciate Ligament Rupture
- Being tested
- Blood Flow Restriction, Brace
- Keywords
- BFR, Blood Flow Restriction, Brace, ACL rupture, ACL
- 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 RestrictionOther
Exercise with restriction of blood flow supply
BraceOther
Knee brace to restrict range of motion
| Study group | Role | What they receive |
|---|---|---|
| Brace and BFR exercise | Experimental | Not described Receives: Other: Blood Flow Restriction; Other: Brace |
| Brace and BFR sham | Sham comparator | Not described Receives: Other: Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Quadriceps strength using a hand held dynamometer
Measured: Enrolment, week 2 and 4, end of intervention (12 weeks)
Secondary outcomes (7)
MRI
Measured: Enrolment and end of intervention at 12 weeks
Knee laxity
Knee arthrometer
Measured: enrolment and end of intervention at 12 weeks
Balance
Star execution test
Measured: enrolment and end of intervention at 12 weeks
Swelling
Knee circumference
Measured: enrolment and end of intervention at 12 weeks
Visual analog scale (VAS)
Visual analog scale for pain measurement. A higher score indicates greater pain intensity 0 indicates no pain while 100 indicates the worst pain.
Measured: enrolment, week 2 and 4 and end of intervention at 12 weeks
Lysholm scale
Lysholm scale: The Lysholm Knee Score is a questionnaire consisting of 8 items. The scale calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. A high score on the Lysholm score list corresponds to a low degree of knee instability.
Measured: enrolment and end of intervention at 12 weeks
Patient reported outcome measures
Tegner scale:
The TAS is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes.
Measured: enrolment and end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Sep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ACLStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexios Pitsillides, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727344
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2024/70
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To keep the study double blinded
Publications
Pitsillides A, Stasinopoulos D, Giannakou K. Healing potential of the anterior cruciate ligament in terms of fiber continuity after a complete rupture: A systematic review. J Bodyw Mov Ther. 2021 Oct;28:246-254. doi: 10.1016/j.jbmt.2021.06.003. Epub 2021 Jun 12.
PubMed 34776148Filbay SR, Dowsett M, Chaker Jomaa M, Rooney J, Sabharwal R, Lucas P, Van Den Heever A, Kazaglis J, Merlino J, Moran M, Allwright M, Kuah DEK, Durie R, Roger G, Cross M, Cross T. Healing of acute anterior cruciate ligament rupture on MRI and outcomes following non-surgical management with the Cross Bracing Protocol. Br J Sports Med. 2023 Dec;57(23):1490-1497. doi: 10.1136/bjsports-2023-106931. Epub 2023 Jun 14.
PubMed 37316199Pitsillides A, Constantinou A, Karagiannis C, Giannakou K. Conservative treatment using blood flow restriction and brace in individuals with complete anterior cruciate ligament rupture: protocol for a randomised clinical trial. J Orthop Surg Res. 2025 Dec 1;21(1):10. doi: 10.1186/s13018-025-06285-y.
PubMed 41327334
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative Treatment With Blood Flow Restriction With Standard Management in Total ACL Rupture. "Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT06727344
- Acronym / sponsor ID
- ΕΕΒΚ/ΕΠ/2024/70
- Conditions
- ACL, ACL - Anterior Cruciate Ligament Rupture
- Keywords
- BFR, Blood Flow Restriction, Brace, ACL rupture, ACL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Dec 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 goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture.
The main questions it aims to answer are:
- Does blood flow restriction adds any additional benefits to conservative treatment of the ACL?
- Does bracing promotes spontaneous healing to the ACL
Researchers will compare bracing and BFR to bracing and sham BFR to see if the intervention provides any additional benefits to the conservative management of this injury.
Participants will:
- Use a knee brace for 6 weeks with adjustments according to protocol
- Follow and identical exercise plan with either BFR (intervention group) or BFR sham (control group)
- Follow a home based exercise program.
Detailed description
Methodological design:
For the purposes of the present study, a double-blind, two-arm randomised clinical trial will be conducted. Participants in the intervention group will undergo and exercise protocol with the use of blood flow restriction (BFR). Participants in control group will follow the same exercise protocol but with sham BFR instead. Both groups will follow the same brace protocol.
Intervention group:
The intervention group will consist of people with a recent ACL tear who meet the eligibility criteria. Participants in this group will follow a splint use protocol. In particular, during the first 3 weeks (phase 1) a splint will be used with the knee immobilised at 90°, non-weight bearing walking with the use of walking aids according to age and mobility. During the 4th and 5th week (phase 2) the range of motion of the splint will be set to 60° to 90° and from 30° to 90° respectively. Walking will remain non-weight bearing. During the 6th week (phase 3) the degree of freedom of the splint will be placed at 0° allowing full flexion but preventing hyperextension of the joint. During this phase, partial bearing is allowed with the use of a walking aid. From the 7th week (phase 4) onwards the splint is removed and walking is done with no loading restrictions.
Regarding the exercise program, participants in this group, during phase 1, will perform isometric quadriceps and hamstring contractions guided by a visual stimulus from an electronic hand dynamometer. The exercise parameters will be 75 repetitions divided into 4 sets (30,15,15,15) at 30% of the 1st maximum of the opposite leg. During phase 2, the exercise protocol is maintained as phase 1 with the only differences that the exercises will be performed at 60 degrees too. Additionally, the "sliding" exercise will be added where the heel is dragged on the bed causing knee flexion as well as the skateboard sliding exercise from a seated position in the allowed range of motion. Exercise parameters remain the same for all exercises as previous phase. In the 3rd phase, single leg squats up to 45° are added. Exercise parameters remain the same. In the 4th phase, the exercise protocol changes. Subjects start at a stationary bike for 5 minutes (without BFR) and the quadriceps and hamstrings isometrics are replaced with resistance exercises for extension and knee flexion. Sliding and single-leg squats are performed at an increased range of flexion (up to 90°) and climbing a 30cm step is added. All exercise parameters remain the same as in the previous phases. During the last phase (5th) gait retraining on a treadmill for 5 minutes and Y balance exercise is added. Both of these exercises will be performed without BFR. The break between sets will be 30 seconds and between exercises 1 minute.
The exercise program of the intervention group will be performed under lower extremity blood flow restriction. Cuff pressure will be reduced during the breaks. The execution speed of the exercises will be 2 seconds of contraction followed by 2 seconds of return. Hold in all isometric exercises will be 3 seconds.
Initial measurements will be taken upon enrollment of participants and will include MRI, Lachman test, arthrometer, strength, swelling, Lysholm scale, Tegner scale, pain (Vas), exercise pain (Vas). By the end of 2nd and 4th week, strength, swelling and pain (Vas) will be reassessed. The final measurements will be taken at the end of the intervention period and will include all the measurements taken initially.
The participants will be given a home-base exercise program through an electronic platform which will provide the possibility of monitoring their compliance. At the same time, through the platform, the correct execution of the exercises will be ensured as all the exercises will be presented with videos and specific exercise parameters.
Control Group:
The control group will perform an identical program of splinting, exercises, home exercises and measurements as the intervention group. The blood flow restriction protocol will be performed in an identical manner to the intervention group, with only difference being that variables setting will be set at a control program (sham).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brace and BFR exercise | Experimental | Other: Blood Flow Restriction, Other: Brace |
| Brace and BFR sham | Sham comparator | Other: Brace |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- MRI-confirmed complete rupture of ACL. Ability to communicate and read fluently in Greek and be willing to keep their leg immobilised for the required period based on the study protocol.
Key exclusion criteria (1 listed)
- Heart disease, overweight, diabetes, pregnancy, thrombophilia, atrial fibrillation, heart failure, cancer, use of drugs that may increase blood clotting, use of hormones or contraceptives, any reason for not using BFR e.g., an open wound or serious skin problems and/or allergies to the cuff material.
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 RestrictionExercise with restriction of blood flow supply | Other | Brace and BFR exercise |
| BraceKnee brace to restrict range of motion | Other | Brace and BFR exercise, Brace and BFR sham |
Primary outcome
Strength
Time frame: Enrolment, week 2 and 4, end of intervention (12 weeks)
Quadriceps strength using a hand held dynamometer
7 secondary outcomes
MRI
Time frame: Enrolment and end of intervention at 12 weeks
Knee laxity
Time frame: enrolment and end of intervention at 12 weeks
Balance
Time frame: enrolment and end of intervention at 12 weeks
Swelling
Time frame: enrolment and end of intervention at 12 weeks
Visual analog scale (VAS)
Time frame: enrolment, week 2 and 4 and end of intervention at 12 weeks
Lysholm scale
Time frame: enrolment and end of intervention at 12 weeks
Patient reported outcome measures
Time frame: enrolment and end of intervention at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 34776148Pitsillides A, Stasinopoulos D, Giannakou K. Healing potential of the anterior cruciate ligament in terms of fiber continuity after a complete rupture: A systematic review. J Bodyw Mov Ther. 2021 Oct;28:246-254. doi: 10.1016/j.jbmt.2021.06.003. Epub 2021 Jun 12.
- Results publication: PubMed 37316199Filbay SR, Dowsett M, Chaker Jomaa M, Rooney J, Sabharwal R, Lucas P, Van Den Heever A, Kazaglis J, Merlino J, Moran M, Allwright M, Kuah DEK, Durie R, Roger G, Cross M, Cross T. Healing of acute anterior cruciate ligament rupture on MRI and outcomes following non-surgical management with the Cross Bracing Protocol. Br J Sports Med. 2023 Dec;57(23):1490-1497. doi: 10.1136/bjsports-2023-106931. Epub 2023 Jun 14.
- Derived from this study: PubMed 41327334Pitsillides A, Constantinou A, Karagiannis C, Giannakou K. Conservative treatment using blood flow restriction and brace in individuals with complete anterior cruciate ligament rupture: protocol for a randomised clinical trial. J Orthop Surg Res. 2025 Dec 1;21(1):10. doi: 10.1186/s13018-025-06285-y.
- Individual participant dataSharing planned: No. To keep the study double blinded
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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.
2 sites 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 and Brace in people with ACL and ACL - Anterior Cruciate Ligament Rupture, run by European University Cyprus at 2 sites in Cyprus.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis N Pitsillides, PhD candidate (0035799418065, alexpitsillides@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: Enrolment, week 2 and 4, end of intervention (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06727344, which also lists 3 linked publications.
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 3 Apr 2025.