Anterior Cruciate Ligament Reconstruction RehabilitationNCT06762392
Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
A study testing Blood Flow Restriction and Standard Rehabilitation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Blood Flow Restriction and Standard Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 1 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 45 years.
- Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery
Who cannot join
- Cardiovascular comorbidities
- Severe metabolic disorders or postoperative complications
- Previous joint disorders requiring surgery on the affected leg
- Pregnancy
- Coagulation disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy
Valencia, Valencia, 46010
Borja Perez-Dominguez, PhD, +34 697464680, f.borja.perez@uv.es
About this study
The goal of this clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery.
The main questions it aims to answer are:
Read more
Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone?
Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery?
Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.
Read the detailed description
Anterior Cruciate Ligament (ACL) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. Despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role.
This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely.
The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.
- Being tested
- Blood Flow Restriction, Standard Rehabilitation
- Keywords
- Physical Therapy, Rehabilitation, Anterior Cruciate Ligament, Blood Flow Restriction, Randomized Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionOther
Blood Flow Restriction (BFR) therapy in this study involves the application of a pneumatic cuff around the proximal thigh to restrict arterial blood flow during specific rehabilitation exercises. The cuff will be inflated to achieve 70-80% of arterial occlusion, while participants perform low-intensity resistance exercises at 15-20% of their one-repetition maximum (1RM). BFR therapy will be used during Phase 2 of rehabilitation (weeks 2-12) alongside a standardized rehabilitation protocol. The intervention will be closely monitored by trained Physical Therapists to ensure safety and efficacy, with pressure adjustments made in real-time based on the participant's exercise performance. This intervention distinguishes itself by its use of BFR, a technique that is not part of conventional ACL rehabilitation
Standard RehabilitationOther
The Standard Rehabilitation (RHB) intervention in this study consists of a structured, evidence-based protocol designed to optimize recovery after anterior cruciate ligament (ACL) reconstruction. This rehabilitation protocol is implemented across four phases. The rehabilitation will be supervised by experienced Physical Therapists, and participants will be given a tailored home exercise program to complement the supervised sessions. The intervention aims to optimize recovery, restore function, and reduce the risk of re-injury.
| Study group | Role | What they receive |
|---|---|---|
| Standard Rehabilitation | Active comparator | Participants in this group will receive a standardized post-operative rehabilitation protocol specifically designed for ACL reconstruction recovery. The protocol includes progressive exercises tailored to the recovery phases: early recovery (Phase 1), strength and neuromuscular control (Phase 2), agility and landing mechanics (Phase 3), and return to sport (Phase 4). Sessions will be supervised weekly by trained Physical Therapists, with additional unsupervised exercises to be performed at home or in the gym. This protocol follows current evidence-based guidelines without the incorporation of blood flow restriction therapy Receives: Other: Standard Rehabilitation |
| Standard Rehabilitation + Blood Flow Restriction | Experimental | Participants in this group will follow the same standardized post-operative rehabilitation protocol as the Active Comparator group, tailored to the recovery phases for ACL reconstruction (Phases 1-4). In addition, during Phase 2 (weeks 2-12), participants will undergo blood flow restriction (BFR) therapy during specific strengthening exercises. The BFR intervention involves applying a pneumatic cuff to the proximal thigh to achieve 70-80% arterial occlusion, combined with low-intensity resistance exercises (15-20% of 1RM). This approach aims to enhance muscle strength and recovery while minimizing joint stress. Sessions will be supervised weekly by trained Phyisical Therapists. Receives: Other: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS), a self-reported measure where the participant marks their perceived pain on a 100mm line, with one end representing "no pain" and the other representing the "worst pain imaginable." The VAS provides a subjective measure of pain intensity, enabling the tracking of pain levels over time to evaluate the impact of the intervention on pain relief. This is a commonly used tool to gauge pain perception in both clinical and research settings.
Measured: From baseline to the end of the intervention at 24 weeks
Strength
Strength will be assessed using handheld dynamometry, an objective measure of muscle force production. Participants will perform maximal voluntary contractions against the dynamometer, which quantifies force output in Newtons (N) or kilograms (kg). This method provides a reliable and valid measure of muscle strength, allowing for the evaluation of changes over time in response to the intervention.
Measured: From baseline to the end of the intervention at 24 weeks
Range of Motion
Range of Motion (ROM) will be assessed using goniometry, a standardized method for measuring joint flexibility and movement capacity. A goniometer will be positioned at the joint of interest, and participants will perform active and/or passive movements while the angular displacement is recorded in degrees. This technique provides an objective measure of joint mobility, enabling the evaluation of changes over time in response to the intervention
Measured: From baseline to the end of the intervention at 24 weeks
Secondary outcomes (3)
Kinesiophobia
Kinesiophobia, or the fear of movement due to pain or injury-related concerns, will be assessed using the Tampa Scale for Kinesiophobia-11 (TSK-11), a validated self-reported questionnaire. The TSK-11 consists of 11 items that evaluate fear-avoidance beliefs related to movement and physical activity. Participants rate their level of agreement with each statement on a Likert scale, generating a total score that reflects the severity of movement-related fear.
Measured: From baseline to the end of the intervention at 24 weeks
Patient's Quality of Life
Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12), a validated self-reported questionnaire that measures physical and mental health status. The SF-12 evaluates key domains such as physical functioning, pain, general health perceptions, vitality, social functioning, emotional well-being, and mental health. Scores are calculated to generate composite measures of physical and mental health, allowing for the assessment of overall well-being and the impact of the intervention on participants' quality of life
Measured: From baseline to the end of the intervention at 24 weeks
Functional Performance
Functional performance will be assessed through a series of validated physical tests designed to evaluate lower limb strength, endurance, and neuromuscular control. Participants will complete the following tests (1) Single Heel Rise (Step Test): The participant stands on one leg on a step and performs repeated heel raises until fatigue or failure to maintain proper form. This test assesses calf muscle endurance and strength (2) Single Leg Bridge: The participant lies supine with their heel positioned 60 cm above the floor and performs repeated single-leg hip bridges. This test evaluates posterior chain strength, particularly in the gluteal and hamstring muscles (3) Single Leg Squat: The participant performs a squat on one leg, aiming to reach 60° of knee flexion while maintaining balance and proper form. This test measures lower limb strength, stability, and motor control.
Measured: From baseline to the end of the intervention at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Pérez-Domínguez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762392
- Sponsor's protocol ID
- UV-INV_ETICA-3498956
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
- ClinicalTrials.gov ID
- NCT06762392
- Acronym / sponsor ID
- UV-INV_ETICA-3498956
- Keywords
- Physical Therapy, Rehabilitation, Anterior Cruciate Ligament, Blood Flow Restriction, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Jan 2025 (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 clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery.
The main questions it aims to answer are:
Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone?
Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery?
Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.
Detailed description
Anterior Cruciate Ligament (ACL) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. Despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role.
This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely.
The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation | Active comparator | Other: Standard RehabilitationParticipants in this group will receive a standardized post-operative rehabilitation protocol specifically designed for ACL reconstruction recovery. The protocol includes progressive exercises tailored to the recovery phases: early recovery (Phase 1), strength and neuromuscular control (Phase 2), agility and landing mechanics (Phase 3), and return to sport (Phase 4). Sessions will be supervised weekly by trained Physical Therapists, with additional unsupervised exercises to be performed at home or in the gym. This protocol follows current evidence-based guidelines without the incorporation of blood flow restriction therapy |
| Standard Rehabilitation + Blood Flow Restriction | Experimental | Other: Blood Flow RestrictionParticipants in this group will follow the same standardized post-operative rehabilitation protocol as the Active Comparator group, tailored to the recovery phases for ACL reconstruction (Phases 1-4). In addition, during Phase 2 (weeks 2-12), participants will undergo blood flow restriction (BFR) therapy during specific strengthening exercises. The BFR intervention involves applying a pneumatic cuff to the proximal thigh to achieve 70-80% arterial occlusion, combined with low-intensity resistance exercises (15-20% of 1RM). This approach aims to enhance muscle strength and recovery while minimizing joint stress. Sessions will be supervised weekly by trained Phyisical Therapists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 45 years.
- Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery
Key exclusion criteria (5 listed)
- Cardiovascular comorbidities
- Severe metabolic disorders or postoperative complications
- Previous joint disorders requiring surgery on the affected leg
- Pregnancy
- Coagulation disorders
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 RestrictionBlood Flow Restriction (BFR) therapy in this study involves the application of a pneumatic cuff around the proximal thigh to restrict arterial blood flow during specific rehabilitation exercises. The cuff will be inflated to achieve 70-80% of arterial occlusion, while participants perform low-intensity resistance exercises at 15-20% of their one-repetition maximum (1RM). BFR therapy will be used during Phase 2 of rehabilitation (weeks 2-12) alongside a standardized rehabilitation protocol. The intervention will be closely monitored by trained Physical Therapists to ensure safety and efficacy, with pressure adjustments made in real-time based on the participant's exercise performance. This intervention distinguishes itself by its use of BFR, a technique that is not part of conventional ACL rehabilitation | Other | Standard Rehabilitation + Blood Flow Restriction |
| Standard RehabilitationThe Standard Rehabilitation (RHB) intervention in this study consists of a structured, evidence-based protocol designed to optimize recovery after anterior cruciate ligament (ACL) reconstruction. This rehabilitation protocol is implemented across four phases. The rehabilitation will be supervised by experienced Physical Therapists, and participants will be given a tailored home exercise program to complement the supervised sessions. The intervention aims to optimize recovery, restore function, and reduce the risk of re-injury. | Other | Standard Rehabilitation |
Primary outcome
Pain Intensity
Time frame: From baseline to the end of the intervention at 24 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS), a self-reported measure where the participant marks their perceived pain on a 100mm line, with one end representing "no pain" and the other representing the "worst pain imaginable." The VAS provides a subjective measure of pain intensity, enabling the tracking of pain levels over time to evaluate the impact of the intervention on pain relief. This is a commonly used tool to gauge pain perception in both clinical and research settings.
Strength
Time frame: From baseline to the end of the intervention at 24 weeks
Strength will be assessed using handheld dynamometry, an objective measure of muscle force production. Participants will perform maximal voluntary contractions against the dynamometer, which quantifies force output in Newtons (N) or kilograms (kg). This method provides a reliable and valid measure of muscle strength, allowing for the evaluation of changes over time in response to the intervention.
Range of Motion
Time frame: From baseline to the end of the intervention at 24 weeks
Range of Motion (ROM) will be assessed using goniometry, a standardized method for measuring joint flexibility and movement capacity. A goniometer will be positioned at the joint of interest, and participants will perform active and/or passive movements while the angular displacement is recorded in degrees. This technique provides an objective measure of joint mobility, enabling the evaluation of changes over time in response to the intervention
3 secondary outcomes
Kinesiophobia
Time frame: From baseline to the end of the intervention at 24 weeks
Patient's Quality of Life
Time frame: From baseline to the end of the intervention at 24 weeks
Functional Performance
Time frame: From baseline to the end of the intervention at 24 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 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 and Standard Rehabilitation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 5 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 5 Mar 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 Spain. 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. 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 Borja Perez-Dominguez, Ph.D. (+34 697 46 46 80, f.borja.perez@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: From baseline to the end of the intervention at 24 weeks). The study lists 3 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 5 Mar 2026.