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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

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.

Eligibility

Primary outcome measure(s)

• Pain Intensity — 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 — 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 — 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

Trial sites (1)

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