Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy

実験的：Group A: Active Anodal Transcranial direct current stimulation + Task-Oriented Training

Participants receive active anodal transcranial direct current stimulation (tDCS) applied concurrently with task-oriented training.

デバイス：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 task circuits, progressing from simple to complex tasks based on child performance.

偽コンパレータ：Sham Transcranial direct current stimulation + Task-Oriented Training

Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.

デバイス：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.

実験的：Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy

Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.

デバイス：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 minutes Difficulty automatically progresses based on performance metrics (speed, accuracy, movement amplitude)

偽コンパレータ：Sham Transcranial direct current stimulation + Virtual Reality Therapy

Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.

デバイス：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

アクティブコンパレータ：Conventional Physiotherapy

Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.

他の：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.

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).

Assesses walking speed in children

Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s)

Assesses mobility and balance in children

Timed Up and Go (TUG): Assesses mobility and balance. (get out of a chair, walk three meters, turn, come back, and sit); time in seconds, average of two trials.

Measures balance and reach ability in children

Functional Reach Test (FRT): Measures balance and reach ability. Two to three attempts are recorded in centimeters for the standard forward reach distance.

Assesses manual dexterity in children

Box & Block Test (BBT): Assesses manual dexterity. The number of 1-inch cubes moved over the partition in 60 seconds, tested independently for each hand, and one practice trial was used to measure the standard BBT.

Measures spasticity and muscle tone in children

Modified Tardieu Scale (MTS): Measures spasticity and muscle tone. Joint specific passive stretches are carried out at predetermined speeds (V1, V2, V3)

Measures functional performance and disability in children.

Pediatric Evaluation of Disability Inventory (PEDI / PEDI-CAT): Measures functional performance and disability. record functional skills, caregiver support, and changes in self-care, mobility, and social function

Assesses the child's self-esteem

Rosenberg Self-Esteem Scale (Child Version): Assesses the child's self-esteem. 10-item, 4-point Likert scale; total score represents overall self-esteem