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NCT06818201 | NOT YET RECRUITING | Anterior Cruciate Ligament Reconstruction Rehabilitation


Effects of tDCS on Motor Cortex During ACL Recovery
Sponsor:

Catholic University Foundation of Valencia San Vicente Mártir

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.

Condition or disease

Anterior Cruciate Ligament Reconstruction Rehabilitation

Intervention/treatment

NIBS

Rehabilitation

Sham Comparator

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 54 participants
Masking : TRIPLE
Masking Description : The groups will be randomly assigned, and a double-blind procedure will be employed as the masking technique. Subject selection will be conducted randomly using the EPIDAT 3.1 program. Both the participants and the researcher responsible for data collection will remain unaware of the assigned intervention and the results obtained, respectively, until the study's conclusion. An independent researcher will generate a table of random numbers using an Excel formula to blind data collectors and outcome adjudicators, thereby ensuring unbiased outcome ascertainment.
Primary Purpose : TREATMENT
Official Title : Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients
Actual Study Start Date : 2025-05-22
Estimated Primary Completion Date : 2026-12-22
Estimated Study Completion Date : 2026-12-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years to 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Effects of tDCS on Motor Cortex During ACL Recovery

Location Details

NCT06818201


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