Anterior Cruciate Ligament Reconstruction RehabilitationNCT06818201
Effects of tDCS on Motor Cortex During ACL Recovery
A study testing NIBS and Rehabilitation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- NIBS and Rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 28 Nov 2025to 27 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
OTRI OTRI contact
Spain1 site, 1 recruiting
- Recruiting
Catholic Univerity of Valencia
Valencia, Valencia, 46001
Josep Lopez Soler, PhD Student, +34 655174010, josep.soler@ucv.es
Juan V-M Vicente Mampel, PhD, +34 674177877, juan.vicente@ucv.es
About this study
Official title: Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients
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.
Read the 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.
- Being tested
- NIBS, Rehabilitation, Sham Comparator
- Keywords
- motor control, Anterior Cruciate Ligament, exercise, tDCS
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIBSDevice
A 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.
RehabilitationProcedure or surgery
This 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 ComparatorBehavioural
The 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
| Study group | Role | What they receive |
|---|---|---|
| NIBS + rehabilitation | Experimental | The intervention using tDCS will be performed through the Home tDCS device (Ionclinics®). It will be introduced in the first part of the rehabilitation, during activation, because the required exercises will be of lower intensity, complexity, and more compatible with this intervention. Receives: Device: NIBS; Procedure: Rehabilitation |
| ShamNIBS + RHB | Sham comparator | The 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 Receives: Procedure: Rehabilitation; Behavioral: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: At baseline, 90days post-surgery, 180days post-surgery
Secondary outcomes (6)
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
Measured: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
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.
Measured: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
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)
Measured: 60days post-surgery, 90days post-surgery and 180days post-surgery
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.".
Measured: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Pain Catastrophizing Scale
Pain Catastrophizing Scale (PCS) is a self-administered questionnaire (13 items on a Likert-type scale from 0 to 4), will be used in this study to assess the level of catastrophizing in the presence of pain.
Measured: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
EGGTMS
Brain Sight ® software to register the hotspot or point of greatest cortical activity following TMS stimulation. The hotspot helps establish the stimulation point to detect the motor threshold of activity using TMS.
Measured: At baseline, 90days post-surgery, 180days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start28 Nov 2025
- Primary completion27 Dec 2027 (estimated)
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the effects of combined tDCS and exercise-based rehabilitation targeting neuromuscular control, comparing it to sham tDCS treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818201
- Sponsor's protocol ID
- UCV/2023-2024/053
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data presented in this study are available on request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients
- ClinicalTrials.gov ID
- NCT06818201
- Acronym / sponsor ID
- UCV/2023-2024/053
- Keywords
- motor control, Anterior Cruciate Ligament, exercise, tDCS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 27 Dec 2027 (estimated)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To evaluate the effects of combined tDCS and exercise-based rehabilitation targeting neuromuscular control, comparing it to sham tDCS treatment.
| Arm | Type | Receives |
|---|---|---|
| NIBS + rehabilitation | Experimental | Device: NIBS, Procedure: RehabilitationThe intervention using tDCS will be performed through the Home tDCS device (Ionclinics®). It will be introduced in the first part of the rehabilitation, during activation, because the required exercises will be of lower intensity, complexity, and more compatible with this intervention. |
| ShamNIBS + RHB | Sham comparator | Procedure: Rehabilitation, Behavioral: Sham ComparatorThe 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 |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIBSA 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. | Device | NIBS + rehabilitation |
| RehabilitationThis 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 | Procedure or surgery | NIBS + rehabilitation, ShamNIBS + RHB |
| Sham ComparatorThe 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 | Behavioural | ShamNIBS + RHB |
Primary outcome
Electromyography (EMGs)
Time frame: At baseline, 90days post-surgery, 180days post-surgery
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 .
6 secondary outcomes
Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL)
Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Lysholm Scale
Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Functional Jump Test
Time frame: 60days post-surgery, 90days post-surgery and 180days post-surgery
Tampa Scale of Kinesiophobia
Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Pain Catastrophizing Scale
Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
EGGTMS
Time frame: At baseline, 90days post-surgery, 180days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided. The data presented in this study are available on request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
OTRI OTRI contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIBS and Rehabilitation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Vicente Mampel, PhD (+34963637412 ext. 6437, juan.vicente@ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (EMGs) (time frame: At baseline, 90days post-surgery, 180days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.