About this trial
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training
DeviceActive 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 task circuits, progressing from simple to complex tasks based on child performance.
Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training
DeviceSham 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.
Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
DeviceActive 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 minutes Difficulty automatically progresses based on performance metrics (speed, accuracy, movement amplitude)
Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
DeviceSham 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
Conventional Physiotherapy
Other intervention* 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Cortical Activity
Quantitative electroencephalography (EEG) parameters to assess changes in brain activity specifically cortical activity. EEG data will be recorded using a 14-channel system with electrodes placed according to the international 10-20 system, ensuring adequate spatial coverage of relevant cortical regions. Resting-state EEG will be obtained under eyes-open and eyes-closed conditions (5 minutes each) to evaluate baseline neural activity. At the event-related potentials (ERPs) cortical activity will be recorded during cognitive tasks such as oddball or Go/No-Go paradigms. Primary outcomes will include changes in power spectral density across standard frequency bands and alterations in ERP components (P3, N2, P2) in terms of amplitude and latency.
Change in Muscle Synergy Patterns
The outcome measures for this clinical trial will include quantitative electromyography (EMG) parameters and muscle synergy analysis to evaluate neuromuscular function. Surface EMG signals will be recorded from key upper and lower limb muscles, including tibialis anterior, gastrocnemius medialis, soleus, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, gluteus medius, flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii, deltoid, and first dorsal interosseous, at a sampling rate of ≥1000-2000 Hz following SENIAM guidelines for electrode placement. Primary outcomes will include normalized EMG amplitude and temporal activation patterns during functional tasks, processed band-pass filtering (20-450 Hz), rectification, and envelope smoothing. Muscle activity will be normalized using the maximum voluntary contraction (MVC) or peak-amplitude methods. Secondary outcomes will include muscle synergy characteristics derived using a non-negative matrix
Measure Gross Motor Function children.
GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking.
Measures balance in children.
Balance will be evaluated using the Pediatric Balance Scale (PBS; Children's Modified Berg, 14 items scored 0-4).
Locations
Sponsors and contacts
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