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

NCT06762392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-05

No results posted yet for this study

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

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 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

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.

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-30
Completion
2027-01-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762392 on ClinicalTrials.gov