Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Flow Restriction, Standard Rehabilitation.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Blood Flow Restriction
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 i - Other Standard Rehabilitation
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, a
Primary outcome measures
- Pain Intensity [Time frame: From baseline to the end of the intervention at 24 weeks]
- Strength [Time frame: From baseline to the end of the intervention at 24 weeks]
- Range of Motion [Time frame: From baseline to the end of the intervention at 24 weeks]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Patients aged between 18 and 45 years.
- Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery
Exclusion criteria
- Cardiovascular comorbidities
- Severe metabolic disorders or postoperative complications
- Previous joint disorders requiring surgery on the affected leg
- Pregnancy
- Coagulation disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Faculty of Physiotherapy — Valencia
Identifiers
NCT: NCT06762392 · UV-INV_ETICA-3498956