RecruitingACTRN12622000325707

Integrated versus traditional rehabilitation program after anterior cruciate ligament (ACL) reconstruction in high level athletes

Evaluation of a new integrated rehabilitation program versus a traditional rehabilitation program in the postoperative high-level athletes with anterior cruciate ligament reconstruction


Sponsor

University of L'Aquila

Enrollment

40 participants

Start Date

May 3, 2021

Study Type

Interventional

Conditions

Summary

Anterior cruciate ligament (ACL) injury is a common knee injury sustained by athletes. Patients seeking return to activity commonly undergo anterior cruciate ligament reconstruction (ACL-R) to re-establish me¬chanical knee stability. Currently, There is no consensus on the ideal rehabilitation program for patients undergoing ACL reconstruction as there are various clinical practices for the management of this injury. Until now 35–45% of patients undergoing ACL-R do not return to Sport (RTS). Even in elite sports environments, typically 20–25% of athletes are unable to RTS after ACLR. More importantly, those who RTS do so at unacceptable re-injury risk. The overall secondary ACL injury risk after ACL-R is around 15% .Currently the rehabilitation programs are divided into phases, and each phase focuses on the treatment of 1 or 2 functional deficits induced by the injury and subsequent ACL-R . As such, it appears that typically adopted rehabilitation criteria after ACL-R need improvement. We believe that the rehabilitation program, especially in elite athletes, should be more complete, including, from the early stages of rehabilitation, the treatment of the various neurophysiological, biomechanical and metabolic components that characterize an athlete's performance, such as the sensory-motor function, neuromuscular, biomechanical, and cardiovascular conditioning, quality of movement, etc., through a correct and careful dosage of the workload of each component during rehabilitation progression. The purpose of this prospective randomized controlled study is to compare an innovative integrated rehabilitation program and the traditional rehabilitation program in terms of functional improvement, i.e., pain, joint amplitude, and performance-related factors, in patients who undergone ACL-R This may be clinically important to optimize the rehabilitation process with the aim of preventing the still high re-injury rate after ACL-R.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

An anterior cruciate ligament (ACL) tear is one of the most feared injuries for athletes — it affects the main stabilising ligament of the knee and typically requires surgery followed by months of rehabilitation. Despite advances in surgical techniques, between 35–45% of athletes never fully return to their sport, and re-injury rates remain high. This suggests current rehabilitation approaches have room for improvement. This Italian study compares a new "integrated" rehabilitation program against the traditional approach. The integrated program works on multiple aspects of athletic performance from early in recovery — including sensory-motor function, neuromuscular strength, movement quality, and cardiovascular fitness — rather than tackling one element at a time. The goal is better, faster, and more durable recovery for high-level athletes. You may be eligible if you are a high-level athlete between 18 and 40 years old who has recently undergone ACL reconstruction surgery. Athletes with tibial fractures, injury to the ACL in the other knee, or who had a synthetic ligament implant are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Neurophysiological and metabolic capacities that underpin sport practiced by each subject, the parameters of frequency, intensity, recovery, etc. with which each neurophysiological and metabolic capac

Neurophysiological and metabolic capacities that underpin sport practiced by each subject, the parameters of frequency, intensity, recovery, etc. with which each neurophysiological and metabolic capacity will be administered to each subject will be calibrated on the basis of the results of the evaluation tests carried out for each neurophysiological and metabolic capacity and modulated in relation to the residual functional capacities of each subject in each specific period of rehabilitation program. The correct development of an integrated post Anterior Cruciate Ligament Reconstruction (ACL-R) rehabilitation program requires an assessment of the functional requirements imposed by the sport practiced by the athlete who will be rehabilitated, as well as a knowledge of the training principles applied in his/her specific sport. This requires a close collaboration between physician, physiotherapist and athletic trainer. In addition, a periodic re-evaluation of the athlete is necessary during the rehabilitation program in order to acquire the information necessary to manipulate the various variables (load intensity, repetitions, recovery time, etc.) to achieve the desired objectives, always keeping considering what are the functional requirements of the sport practiced. Traditional rehabilitation after an injury still follows predetermined blocks in a fixed timeline, the integrated rehabilitation program followed by group 2 consider both physical (strength and aerobic parameters) and neuromuscular capacities from the early rehabilitation stage; only dosage changes in time. Moreover, in the integrated rehabilitation program neurophysiological parameters of the sport practiced must be taken into consideration. Generally: integrated rehabilitation program will be divided into two phases: Phase 1 (0-4 months) of supervised rehabilitation sessions of 1 hour, once a day, five times a week, from Monday to Friday, starting 1 week after surgery; and Phase 2 (4-12 months) of sport-specific retraining sessions of 1 hour, four times a week, Monday-Tuesday, Thursday-Friday these sessions will be performed at gym or on field. On a daily basis it will be monitored: • Intervention adherence with an attendance checklist and facilitated every month by a face-to-face session with an unblinded physiotherapist. • Pain assessment test. A visual analog scale (VAS): 0-3 green; 4-5 yellow, and 6-10 red, along with descriptions of pain at each level will be displayed on the interface of each strength equipment and used to track the rate of perceived discomfort during movement and used to assess improvements and managing the overloads progression. The traffic light approach will be used for pain monitoring in both phases. The traffic light has three pain levels on. Feedback on the perception of discomfort in the execution of the exercise will be reported by the patient to the physiotherapist in each session. the goal will be to perform exercises with minimal or no discomfort (light green 0-3 VAS) in both phases; in the second phase an execution with discomfort in yellow light (4-5 VAS) will also be tolerated. • As soon as the patients will have full range of motion and every week, patients following the integrated rehabilitation protocol will undergo series of tests represented by: • strength and power evaluation (Isometric Maximal Voluntari Contraction and Rate of Force Development and s Symmetry) by means of isometric and isotonic test protocol embedded on each equipment for lower limb training (Leg Extension, Leg Curl, Leg Press). • At the beginning of the rehabilitation phase patients will use a ‘viscus resistance’ in which the resistance increases with movement speed. The patients than will progress through an isotonic resistance as soon as he will be able to execute each movement at maximum speed without any discomfort. The percentages of workloads for maximum strength and power will be determined, already from the first phase, respectively at 80-90% and 35-40% of the maximum reached in the isokinetic test, which will be re-determined weekly. • aerobic conditioning to evaluate maximal oxygen consumption on a stationary bike. The test result will be based on the linear relationship between oxygen uptake and heart rate increases. Patients will train at increasing percentages of the maximal oxygen uptake. Aerobic workload capacity will be based on maximal power capacity exertion measured in watts on a stationary bike with a graded exercise test (step of 1 minute). In phase 1 patients will train with a load corresponding to 50% of the measured maximal power capacity. If during the rehabilitation process the load will be perceived as too light it will be updated with increments of 5%. At the beginning of phase two patients will execute a new test and the training intensity will be set at 75% of the maximal power capacity exertion All treatment will be performed at the same rehabilitation center or in field and in both cases under the supervision of qualified physiotherapists, sports specialist personal trainers, and strength and conditioning specialists. An assessment of the neurophysiological and cardiometabolic parameters will be carried out every two months. The intervention provided will depend on whether the predefined criteria will be met at the follow-up assessment every 2 months (i.e. the participant's goals are met, the participant is satisfied with current symptoms / functions, and the overall assessment of change reported as at least improved).


Locations(1)

Italy

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ACTRN12622000325707


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