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

Sponsor
Riphah International University
Study ID
NCT07574996
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

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.
  • 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 * 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 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
    * 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 Details

* 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.

Key Dates

First listed
May 8, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Nov 18, 2027
Completion
Jan 14, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Sham Comparator: Sham Transcranial direct current stimulation + Task-Oriented Training
    Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.
  • 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.
  • Sham Comparator: Sham Transcranial direct current stimulation + Virtual Reality Therapy
    Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
  • Active Comparator: Conventional Physiotherapy
    Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.

Primary Outcome Measure

Change in Cortical Activity [ Time Frame: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up ]

Central Contacts

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