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

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training; Device: Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training; Device: Active Anodal Transcranial Direct Current Stimulation + Virtual Reality; Device: Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality; Other: Conventional Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riafat Mehmood, PhD*; Phone Number: 0333551063; Email: riafat.mehmood@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 task circuits, progressing from simple to complex tasks based on child performance.
Sham Comparator: Sham Transcranial direct current stimulation + Task-Oriented Training; Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.	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.
Experimental: Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy; Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.	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 minutes Difficulty automatically progresses based on performance metrics (speed, accuracy, movement amplitude)
Sham Comparator: Sham Transcranial direct current stimulation + Virtual Reality Therapy; Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.	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
Active Comparator: Conventional Physiotherapy; Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measure Gross Motor Function children.	GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking.	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures balance in children.	Balance will be evaluated using the Pediatric Balance Scale (PBS; Children's Modified Berg, 14 items scored 0-4).	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses walking speed in children	Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s)	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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.	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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.	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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.	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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)	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
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	Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Waqar Ahmed Awan, PhD, Riphah International University; Principal Investigator: Riafat Mehmood, PhD*, Riphah International University; Study Chair: Qamar Mehmood, PhD, Riphah international univesty

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): January 14, 2028

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Virtual reality; Transcranial direct current stimulation; Spastic Cerebral Palsy; Task-oriented training; Pediatric Neurorehabilitation; Muscle synergy; Conventional Physiotherapy; Cortical Activity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: PhD/011109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No