Not yet recruiting NCT07574996
Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training, Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training, Active Anodal Transcranial Direct Current Stimulation + Virtual Reality, Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
* To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy. * To determine the retention effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy, one-month follow-up across the five groups.
Detailed description
* To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on * gross motor function, gait, balance, mobility, dexterity, and spasticity. * executive functions * self-esteem.
Interventions
- Device Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training
Active anodal transcranial direct current stimulation is delivered using a certified tDCS device at a low, safe intensity according to pediatric guidelines. Stimulation is applied to the scalp for approximately 20 minutes per session and is delivered concurrently with task-oriented training. Task-oriented activities individualized to motor deficits, emphasizing: * Functional reaching * Grasp-release tasks * Bilateral coordination * Balance and postural activities * Each session includes 10-15 t - Device Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training
Sham stimulation will mimic active tDCS for the first 30 seconds (ramp up/down) and then deliver no current for the remainder of the session, ensuring blinding. TOT protocol is identical to Group 1. - Device Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
Active anodal transcranial direct current stimulation is delivered using a certified tDCS device at a low, safe intensity according to pediatric guidelines. Stimulation is applied to the scalp for approximately 20 minutes per session and is delivered concurrently with Virtual Reality. System: Pediatric upper-limb and balance VR rehabilitation system Activities: Interactive tasks including * reaching, * stepping, * virtual object manipulation, * coordination games. * Session duration: 30 to 40 m - Device Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
Sham stimulation will mimic active tDCS for the first 30 seconds (ramp up/down) and then deliver no current for the remainder of the session, ensuring blinding. VR protocol identical to Group 3 - Other Conventional Physiotherapy
* Stretching of spastic muscle groups * Strengthening exercises for weak muscle groups * Balance and gait training * Functional mobility practice * Session duration: 45 minutes. Delivered by a trained pediatric physiotherapist following standard clinical guidelines.
Primary outcome measures
- Change in Cortical Activity [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Change in Muscle Synergy Patterns [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Measure Gross Motor Function children. [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Measures balance in children. [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Assesses walking speed in children [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Assesses mobility and balance in children [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Measures balance and reach ability in children [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Assesses manual dexterity in children [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Measures spasticity and muscle tone in children [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
- Measures functional performance and disability in children. [Time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up]
Eligibility criteria
Inclusion criteria
- Children aged 6-18 years.
- Neurologist-confirmed spastic cerebral palsy.
- GMFCS Levels I-III (mild to moderate motor impairment).
- Ability to understand and follow simple instructions.
- Medically stable (no planned major surgery; no recent adjustment of medications affecting cortical excitability).
- Parental/guardian written informed consent and child assent.
Exclusion criteria
- Active uncontrolled epilepsy or history of seizure in the last year.
- Metal implants in the head or implanted medical/electrical devices (e.g., cochlear implants, ventriculoperitoneal shunts, pacemakers).
- Significant visual or auditory impairments that would interfere with task performance.
- Severe behavioral or cognitive difficulties that would prevent safe application of tDCS or training tasks.
- Currently taking medications known to significantly alter cortical excitability (e.g., benzodiazepines, antiepileptics) if dosage is unstable.
- Participation in other experimental neurorehabilitation or brain stimulation interventions within the last 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07574996 · PhD/011109