Actively Recruiting

Phase Not Applicable
Age: 16Years - 40Years
All Genders
ID06818201

Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients

Led by Fundación Universidad Católica de Valencia San Vicente Mártir · Updated on 2025-12-02

54

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Anterior cruciate ligament (ACL) rupture is a common injury, especially among young and active individuals, with many cases occurring during sports activities. This research aims to evaluate the combined effects of transcranial direct current stimulation (tDCS) and exercise-based rehabilitation on neuromuscular control after ACL reconstruction. The study will compare these treatments to a sham stimulation to assess impacts on brain and muscle function, pain, and recovery outcomes. Participants will be randomly assigned to one of two groups: one receiving active tDCS with rehabilitation exercises and the other receiving sham tDCS with rehabilitation. The active tDCS involves 16 sessions over 8 weeks, delivering a low electrical current to the primary motor cortex using a helmet device. Rehabilitation includes 72 sessions of strength-focused exercises over 24 weeks. The sham group receives brief stimulation mimicking the sensation of tDCS without actual brain modulation. Throughout the study, participants will undergo assessments such as electromyography (EMG) at baseline and 90 and 180 days after surgery. Additional evaluations include quality of life questionnaires, functional tests, pain and fear of movement scales at several time points up to 180 days post-surgery. Researchers will monitor brain and muscle activity, recovery progress, and safety during the trial which lasts about six months post-surgery.

CONDITIONS

Brief Title

Effects of tDCS on Motor Cortex During ACL Recovery

Who Can Participate

Age: 16Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of complete ACL tear confirmed by clinical evaluation and MRI imaging
  • Patients who have undergone surgical intervention for ACL injury
  • Aged between 16 and 40 years
  • Tegner activity level of 4 or higher
Not Eligible

You will not qualify if you...

  • Rupture of other tendons, cartilage, bones, or ligaments
  • History of lower limb pathologies such as open surgeries, knee arthroscopies, or femur/tibia fractures
  • Presence of neuromuscular or metabolic diseases
  • Concussion within the past six months
  • History of cranial surgery or presence of intracranial metal clips
  • Use of medications that affect neuronal activity
  • Diagnosed neurological diseases or disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants receive transcranial direct current stimulation (tDCS) or sham stimulation combined with exercise-based rehabilitation to improve neuromuscular control during recovery after ACL surgery.

Twice-weekly tDCS sessions for 8 weeks and thrice-weekly rehabilitation sessions for 24 weeks

Follow-up

Duration - Up to 180 days post-surgery

Participants are monitored after treatment to assess recovery progress and outcomes related to motor function, pain, and quality of life.

Visits at 30, 60, 90, and 180 days post-surgery

Trial Site Locations

Total: 1 location

1

Catholic Univerity of Valencia

Valencia, Valencia, Spain, 46001

Actively Recruiting

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Research Team

J

Juan Vicente Mampel, PhD

O

OTRI OTRI

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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