Cerebral Palsy
Conditions
Keywords
Spastic Cerebral Palsy, Pediatric Neurorehabilitation, Transcranial direct current stimulation, Task-oriented training, Virtual reality, Conventional Physiotherapy, Cortical Activity, Muscle synergy
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.
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.
Interventions
DEVICEActive 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)
DEVICESham 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
OTHERConventional 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.
DEVICEActive 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.
DEVICESham 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.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cortical Activity | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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 | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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. | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking. |
| Measures balance in children. | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | Balance will be evaluated using the Pediatric Balance Scale (PBS; Children's Modified Berg, 14 items scored 0-4). |
| Assesses walking speed in children | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s) |
| Assesses mobility and balance in children | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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 | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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 | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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 | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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. | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | 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 | Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up | Rosenberg Self-Esteem Scale (Child Version): Assesses the child's self-esteem. 10-item, 4-point Likert scale; total score represents overall self-esteem |
Contacts
CONTACTRiafat Mehmood, PhD*
STUDY_CHAIRQamar Mehmood, PhD
Riphah international univesty
STUDY_CHAIRWaqar Ahmed Awan, PhD
Riphah International University
PRINCIPAL_INVESTIGATORRiafat Mehmood, PhD*
Riphah International University
Outcome results
None listed