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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training

    Device

    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.

  • Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training

    Device

    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.

  • Active Anodal Transcranial Direct Current Stimulation + Virtual Reality

    Device

    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)

  • Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality

    Device

    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

  • 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

150 Participants
are divided into 5 treatment groups
Group A: Group A: Active Anodal Transcranial direct current stimulation + Task-Oriented TrainingExperimental treatment 1 intervention
Group B: Sham Transcranial direct current stimulation + Task-Oriented TrainingSham comparator 1 intervention
Group C: Active Anodal Transcranial direct current stimulation + Virtual Reality TherapyExperimental treatment 1 intervention
Group D: Sham Transcranial direct current stimulation + Virtual Reality TherapySham comparator 1 intervention
Group E: Conventional PhysiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
2

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

Time frame
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
3

Measure Gross Motor Function children.

GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking.

Time frame
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
4

Measures balance in children.

Balance will be evaluated using the Pediatric Balance Scale (PBS; Children's Modified Berg, 14 items scored 0-4).

Time frame
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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