Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.

NCT06762392 | Recruiting

• 1 other identifier: UV-INV_ETICA-3498956
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

Physical Therapy; Rehabilitation; Anterior Cruciate Ligament; Blood Flow Restriction; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  From baseline to the end of the intervention at 24 weeks

Secondary Outcomes (3)

• Kinesiophobia

  From baseline to the end of the intervention at 24 weeks

• Patient's Quality of Life

  From baseline to the end of the intervention at 24 weeks

• Functional Performance

  From baseline to the end of the intervention at 24 weeks

Study Arms (2)

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

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.

Other: Blood Flow Restriction

Interventions

Blood Flow Restriction OTHER

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 Rehabilitation + Blood Flow Restriction

Standard Rehabilitation OTHER

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.

Standard Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 45 years.
• Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery

You may not qualify if:

• Cardiovascular comorbidities
• Severe metabolic disorders or postoperative complications
• Previous joint disorders requiring surgery on the affected leg
• Pregnancy
• Coagulation disorders

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Borja Perez-Dominguez, Ph.D.

CONTACT

+34 697 46 46 80; f.borja.perez@uv.es

Enrique Falco-Crespo, PT

CONTACT

+34 669 72 38 19; enrique.falco@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)