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

NCT07574996 | Not Yet Recruiting DMC

• 1 other identifier: PhD/011109
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Cerebral Palsy

Keywords

Spastic Cerebral Palsy; Pediatric Neurorehabilitation; Transcranial direct current stimulation; Task-oriented training; Virtual reality; Conventional Physiotherapy; Cortical Activity; Muscle synergy

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (5)

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

EXPERIMENTAL

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

Sham Transcranial direct current stimulation + Task-Oriented Training

SHAM COMPARATOR

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

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

Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy

EXPERIMENTAL

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

Device: Active Anodal Transcranial Direct Current Stimulation + Virtual Reality

Sham Transcranial direct current stimulation + Virtual Reality Therapy

SHAM COMPARATOR

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

Device: Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality

Conventional Physiotherapy

ACTIVE COMPARATOR

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

Other: Conventional Physiotherapy

Interventions

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.

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

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.

Sham Transcranial direct current stimulation + Task-Oriented Training

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)

Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy

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

Sham Transcranial direct current stimulation + Virtual Reality Therapy

Conventional Physiotherapy OTHER

* 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.

Conventional Physiotherapy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Qamar Mehmood, PhD

  Riphah international univesty

  STUDY CHAIR

• Waqar Ahmed Awan, PhD

  Riphah International University

  STUDY CHAIR

• Riafat Mehmood, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riafat Mehmood, PhD*

CONTACT

0333551063; riafat.mehmood@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study uses a double-blind brain stimulation design with extended masking. Participants, caregivers, therapists delivering task-oriented training or virtual reality therapy, and all outcome assessors are blinded to the type of transcranial direct current stimulation (active or sham). Sham stimulation is delivered using an identical setup and produces the same initial scalp sensation as active stimulation but does not provide continuous current, thereby maintaining blinding. Only the trained research staff member responsible for programming the tDCS device is aware of stimulation assignment and is not involved in intervention delivery, outcome assessment, or data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, double-blind, parallel-group interventional study with five treatment arms. Eligible participants are randomly assigned in a 1:1:1:1:1 ratio to one of five rehabilitation interventions. These include task-oriented training or virtual reality-based therapy delivered with either active or sham transcranial direct current stimulation (tDCS), as well as a conventional physiotherapy group. Randomization is performed using a computer-generated blocked allocation sequence with variable block sizes to ensure balanced group assignment. Parallel-group allocation is maintained throughout the study, with participants receiving only the intervention assigned at enrollment. Blinding is applied to participants, caregivers, therapists, and outcome assessors for the brain stimulation condition. Outcome assessments are conducted at baseline, immediately after the intervention period, and at one-month follow-up to evaluate both immediate and retention effects.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): January 14, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share