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Cerebral PalsyNCT07574996

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

A study testing Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training, Active Anodal Transcranial Direct Current Stimulation + Virtual Reality and Conventional Physiotherapy in people with Cerebral Palsy, run by Riphah International University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training, Active Anodal Transcranial Direct Current Stimulation + Virtual Reality and Conventional Physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 14 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Riafat Mehmood, PhD* contact

0333551063

riafat.mehmood@riphah.edu.pk

About this study

  • 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.
Read the 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.
Conditions
Cerebral Palsy
Being tested
Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training, Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training, Active Anodal Transcranial Direct Current Stimulation + Virtual Reality, Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality, Conventional Physiotherapy
Keywords
Spastic Cerebral Palsy, Pediatric Neurorehabilitation, Transcranial direct current stimulation, Task-oriented training, Virtual reality, Conventional Physiotherapy, Cortical Activity, Muscle synergy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 TrainingDevice

    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 RealityDevice

    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 RealityDevice

    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 PhysiotherapyOther

    • 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.
Study groups in NCT07574996
Study groupRoleWhat they receive
Group A: Active Anodal Transcranial direct current stimulation + Task-Oriented TrainingExperimentalParticipants receive active anodal transcranial direct current stimulation (tDCS) applied concurrently with task-oriented training.
Receives: Device: Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training
Sham Transcranial direct current stimulation + Task-Oriented TrainingSham comparatorParticipants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.
Receives: Device: Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training
Active Anodal Transcranial direct current stimulation + Virtual Reality TherapyExperimentalParticipants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.
Receives: Device: Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
Sham Transcranial direct current stimulation + Virtual Reality TherapySham comparatorParticipants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
Receives: Device: Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
Conventional PhysiotherapyActive comparatorParticipants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 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.

    Measured: 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).

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

  5. Assesses walking speed in children

    Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s)

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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)

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

  10. 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

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

  11. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion18 Nov 2027 (estimated)
  4. Study completion14 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574996
Sponsor's protocol ID
PhD/011109
Status last verified
May 2026
First submitted
17 Feb 2026
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training, Active Anodal Transcranial Direct Current Stimulation + Virtual Reality and Conventional Physiotherapy in people with Cerebral Palsy, run by Riphah International University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Riafat Mehmood, PhD* (0333551063, riafat.mehmood@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cortical Activity (time frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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