Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sham Transcranial direct current stimulation + Task-Oriented Training | Sham Comparator | Participants receive sham (inactive) transcranial direct current stimulation combined with 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. |
|
| Sham Transcranial direct current stimulation + Virtual Reality Therapy | Sham Comparator | Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation. |
|
| Conventional Physiotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riafat Mehmood, PhD* | Contact | 0333551063 | riafat.mehmood@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Qamar Mehmood, PhD | Riphah international univesty | Study Chair |
| Waqar Ahmed Awan, PhD | Riphah International University | Study Chair |
| Riafat Mehmood, PhD* |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| Active Comparator |
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy. |
|
|
| 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
|
|
| 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 |
|
|
| 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 |
| Riphah International University |
| Principal Investigator |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
Not provided
Not provided