About this trial
Anterior Cruciate Ligament (ACL) is a prevalent injury, particularly among young and physically active individuals. The efficacy of transcranial direct current stimulation (tDCS) and exercise-based rehabilitation on neuromuscular control in post-ACL reconstruction patients is evaluated, and these techniques are combined.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis complete ACL tear through clinical evaluation and MRI imaging.
Patients who have received surgical intervention.
Aged between 16 and 40 years.
Tegner activity level of 4 or higher.
Disqualifiers
Rupture, such as tendons, cartilage, bones, or ligaments.
Absence of any pre-existing or current lower limb pathologies, such as open surgeries, knee arthroscopies, or femur/tibia fractures.
Neuromuscular or metabolic diseases.
Concussion within the past six months are not eligible.
Trial design
Parallel
Treatments tested in this trial
NIBS
DeviceA total of 16 sessions will be scheduled, distributed over 8 weeks (2 sessions/week). The continuous current intensity will be set at 2 mA, for 20 minutes. Two electrodes, anode (red) and cathode (black), will be used along with two sponge pads with conductive gel, all combined into a helmet for each patient. The electrodes will be placed according to the international 10-20 system in tDCS. The stimulated area will be the primary motor cortex (M1), so the anode will be placed at the C3 or C4 points and the cathode will be placed at the contralateral supraorbital area Fp1 or Fp2.
Rehabilitation
Procedure/SurgeryThis protocol will consist of 72 sessions, distributed as 3 sessions per week over a period of 24 weeks. Strength will be the prioritized method of work and will be present in all phases. Additionally, periodic measurements will be included to ensure that the patient is making adequate progress and meets the necessary progression criteria to advance to the next phase
Sham Comparator
BehavioralThe device will be configured to produce an ascending ramp lasting 30 seconds, identical to the one used in the experimental group, followed by a descending ramp of another 30 seconds. Thus, the control group will experience a sensation of tingling on the scalp, similar to that felt by the experimental group. This stimulation will have a total duration of 1 minute, which will not be sufficient to induce changes in cortical excitability
Treatment groups
Trial outcomes
Primary outcomes
Electromyography (EMGs)
The The Surface EMG amplitudes of the quadriceps and hamstring muscles. The main device, Musclelab, is equipped with a Musclelab force sensor and wireless surface elec-tromyography (EMGs). Electrode placement will follow the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscle (SENIAM) protocol from the European Concerted Action in the Biomedical Health and Research Program (BIOMED II). The instructions provided to the patients will be to perform the movement with the max-imum possible contraction, and as rapidly as possible, to achieve the highest peak of force. The patient will carry out 3 familiarization repetitions at a submaximal inten-sity at the beginning of each repetition, and it will begin with the non-surgical ex-tremity, followed by the tests on the surgical extremity. Three effective MVIC attempts will be conducted, each lasting 5 seconds, with a 30-second rest interval between each repetition .
Secondary outcomes
Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL)
This scale is of a continuous quantitative nature. It serves as a Patient-Reported Outcome Measure to assess the impact on the lives of patients with ACL, both pre- and post-treatment, regardless of whether the treatment is surgical or non-surgical. The questionnaire comprises 32 items, categorized into 5 domains: symptoms and physical prob-lems (5 items), work-related problems (4 items), sports participation/competition (12 items), lifestyle (6 items), and social and emotional aspects (5 items). Each domain is allocated a proportional score based on the number of items it contains and is evaluated using a 100-millimeter visual analog scale (VAS). A higher score indicates a better quali-ty of life for the patient. This scale was validated in Spanish, demonstrating a Cronbach's alpha of 0.81 and 0.94 and an intraclass correlation coefficient (ICC) that exhibited good consistency, ranging from 0.88 to 0.96
Lysholm Scale
Its purpose is to evaluate knee functionality in various types of ligament injuries, with the objective of monitoring the progression following an intervention and/or assessing knee deterioration in specific pathologies. The scale comprises eight items (limping, use of support for ambulation, instability, pain, locking, swelling, ability to ascend stairs, and ability to squat). It is evaluated on a scale of 0 - 100, with 100-95 being classified as excellent, 94-84 as good, 83-65 as fair, and less than 65 as poor. Furthermore, each item and the overall score are analysed independently. This scale demonstrates a Cronbach's alpha of 0.737 and an intraclass correlation coefficient of 0.844.
Functional Jump Test
Functional Jump Test have been commonly used for the evaluation of patients after ACLR, especially to assess the Limb Symmetry Index (LSI). Consist in 8 jump tests: Single Hop for Distance (SHD), 6m Timed Hop (6MTH), Triple Hop for Distance (THD), Triple Crossover Hop for Distance (TCHD), Single Medial Hop for Distance (MHD), Single Lateral Hop for Distance (LHD), Single Limb Countermovement Jump for Height (SLCMJ), and Timed Speedy Hop Test (TSHT)
Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia is a self-administered questionnaire composed of different questions with a 4-point Likert scale ranging from "strongly disagree" to "strongly agree.".
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