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RECRUITING Not applicable ClinicalTrials.gov

Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy

Sponsor: Riphah International University • ClinicalTrials.gov ID: NCT07829770

Registry updated: 2026-09-21
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Description

Children with spastic diplegic cerebral palsy commonly experience difficulties with balance and may also have challenges involving attention, working memory, cognitive flexibility, and inhibitory control. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may influence motor-cortical excitability, while virtual reality (VR) rehabilitation provides repetitive, interactive, and task-oriented training. This randomized controlled trial will investigate whether active tDCS combined with VR rehabilitation improves balance and executive functions more than sham tDCS combined with the same VR rehabilitation or conventional physical therapy in children with spastic diplegic cerebral palsy. A total of 42 children aged 8 to 16 years with Gross Motor Function Classification System (GMFCS) levels I-III will be randomly assigned in a 1:1:1 ratio to active tDCS plus VR, sham tDCS plus VR, or conventional physical therapy. Participants will complete 18 treatment sessions over six weeks, with three sessions per week. Outcomes will be assessed at baseline, after nine treatment sessions, and after 18 treatment sessions. Balance will be evaluated using the Pediatric Balance Scale and Functional Reach Test. Executive functions will be assessed using the Trail Making Test, Stroop Test, and Digit Span. Lower-limb spasticity will be evaluated using the Modified Tardieu Scale.

Interventions

  • Active Transcranial Direct Current Stimulation (Device)
    Active transcranial direct current stimulation will be delivered using saline-soaked sponge electrodes at an intensity of 1 mA for 20 minutes per session. Stimulation will be administered three times per week for six weeks, for a total of 18 sessions, concurrently with virtual reality rehabilitation. The stimulation montage will target the lower-limb motor cortical region with a supraorbital reference electrode.
  • Sham Transcranial Direct Current Stimulation (Device)
    Sham transcranial direct current stimulation will use the same electrode montage and setup as the active condition. Active current will be delivered only during the initial 30 seconds to reproduce the initial sensory experience of stimulation, after which stimulation will be discontinued while the electrodes remain in place. Sham tDCS will be combined with the same virtual reality rehabilitation protocol as the active tDCS group
  • Virtual Reality Rehabilitation (Behavioral)
    Virtual reality rehabilitation will be delivered using an interactive motion-based rehabilitation system and will include progressively challenging activities targeting postural control, balance, movement coordination, obstacle navigation, visual attention, dual-task performance, and cognitive-motor integration. Training will be delivered three times per week for six weeks, for a total of 18 sessions. The same VR rehabilitation protocol will be provided in both the active and sham tDCS groups.
  • Conventional Physical Therapy (Behavioral)
    Conventional physical therapy will be delivered for approximately 30 minutes per session, three sessions per week for six weeks, for a total of 18 sessions. Treatment will include lower-limb stretching, supported balance and weight-shifting activities, strengthening, motor-control exercises, gait-related training, and progressive functional mobility activities. Exercise difficulty and therapist assistance will be progressed according to participant tolerance and functional ability.

Eligibility criteria

Inclusion Criteria: * Diagnosed with spastic cerebral palsy (spastic diplegia). Age 8-16 years. Gross Motor Function Classification System (GMFCS) levels I-III. Presence of mild to moderate lower-limb spasticity, defined as a Modified Tardieu Scale (MTS) score between 1 and 3 in at least one major lower-limb muscle group, such as the gastrocnemius, hamstrings, or hip adductors. Able to understand and follow verbal instructions. Parent or guardian provides informed consent and the child provides assent Exclusion Criteria: * History of seizures or epilepsy. Implanted metal or electronic devices, such as a pacemaker. Severe cognitive impairment that prevents comprehension of study tasks. Skin allergies, lesions, or other conditions affecting the electrode application sites. Current use of antispasticity medication that could directly influence spasticity outcomes. Botulinum toxin injection within the previous 3 months. Recent orthopedic surgery or change in medication regimen within the previous 5 days. Concurrent participation in alternative or adjunct therapies outside the study protocol. Refusal to participate or withdrawal of consent/assent

Conditions

Spastic Diplegic Cerebral Palsy

Locations

  • Al-Farabi Special Education Centre for Physically Handicapped — Islamabad, Pakistan
  • Sedum School of Rehabilitation — Islamabad, Pakistan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record