Clinical trial NCT06818201: Effects of tDCS on Motor Cortex During ACL Recovery
Official title: Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
Keywords: motor control
Anterior Cruciate Ligament
exercise
tDCS
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 54
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: To evaluate the effects of combined tDCS and exercise-based rehabilitation targeting neuromuscular control, comparing it to sham tDCS treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Anterior cruciate ligament (ACL) rupture is a common injury, particularly among young and physically active individuals, with an incidence of 0.4 to 0.8 injuries per 1,000 person-years. While the majority of ruptures occur during sports activities (65-75%), a significant proportion (25-35%) happen in non-sport settings. Rehabilitation is crucial for recovery, but only 65% of patients return to their pre-injury activity level, and only 55% resume competitive activities. Neuromuscular structures such as the hamstrings and hip abductors play a vital role in reducing the risk of re-injury and aiding post-surgical rehabilitation.

Arthrogenic muscle inhibition (AMI) is a common phenomenon following ACL surgery, affecting quadriceps activation and force generation. While spinal mechanisms of AMI have been extensively studied, the influence of supraspinal centers, such as the motor cortex, in modulating AMI is also recognized. Traditional treatments, such as electrostimulation, are largely ineffective, and non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), combined with exercise rehabilitation, are being explored to improve neuromuscular control.

This study aims to evaluate the effects of combined tDCS and exercise-based rehabilitation, comparing it to sham tDCS treatment. Outcomes will include cortical reorganization, corticospinal activation, pain perception, and psychosocial and functional variables. The central hypothesis is that reducing cortical hyperexcitability will enhance neuromuscular control, leading to improved outcomes and a reduced risk of re-injury.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Cranial surgery or have intracranial metal clips are ineligible.
* Taking medications that affect neuronal activity.
* Neurological diseases or disorders are not eligible for participation.

Primary outcomes:
measure: Electromyography (EMGs)
timeFrame: At baseline, 90days post-surgery, 180days post-surgery
Secondary outcomes:
measure: Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL)
timeFrame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
measure: Lysholm Scale
timeFrame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
measure: Functional Jump Test
timeFrame: 60days post-surgery, 90days post-surgery and 180days post-surgery
measure: Tampa Scale of Kinesiophobia
timeFrame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
measure: Pain Catastrophizing Scale
timeFrame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
measure: EGGTMS
timeFrame: At baseline, 90days post-surgery, 180days post-surgery
Other outcomes:
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