About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 45 years.
Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery
Disqualifiers
Cardiovascular comorbidities
Severe metabolic disorders or postoperative complications
Previous joint disorders requiring surgery on the affected leg
Pregnancy
Trial design
Parallel
Treatments tested in this trial
Blood Flow Restriction
Other interventionBlood 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
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
Secondary outcomes
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.
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
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.
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