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.
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
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
Parallel
Active Transcranial Direct Current Stimulation
DeviceActive 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
DeviceSham 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
BehavioralVirtual 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
BehavioralConventional 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.
Pediatric Balance Scale Total Score
Functional balance will be assessed using the Pediatric Balance Scale (PBS), a 14-item clinical measure of balance during functional activities. Each item is scored from 0 to 4, producing a total score ranging from 0 to 56. Higher scores indicate better functional balance. The PBS total score will be assessed at baseline, mid-intervention, and post-intervention.
Functional Reach Test Performance
Dynamic standing balance will be assessed using the Functional Reach Test (FRT). The primary FRT metric will be maximum forward reach distance measured in centimeters while maintaining a stable standing position without taking a step or losing balance. Greater reach distance indicates better dynamic balance. Completion time in seconds will also be recorded as an additional performance metric, with shorter completion time indicating better performance.
Trail Making Test Part A and Part B Performance
Visual attention, processing speed, and cognitive flexibility will be assessed using the Trail Making Test for Children. Completion time for Part A and Part B will be recorded in seconds. Lower completion times indicate faster cognitive performance. The difference between Part B and Part A completion times (B-A) will also be calculated as an index of the additional cognitive-flexibility and set-shifting demand associated with Part B.
Child Stroop Color and Word Test Performance
Inhibitory control and interference processing will be assessed using a child version of the Stroop Color and Word Test. Performance measures will include word-reading time, color-naming time, color-word interference time, and error score. Completion times will be recorded in seconds, with shorter times indicating faster performance. Fewer errors indicate better inhibitory control and response accuracy.
Modified Tardieu Scale
Lower-limb spasticity will be assessed using the Modified Tardieu Scale (MTS) in the clinically more-spastic index limb. The assessment will characterize velocity-dependent resistance to passive movement across relevant lower-limb muscle groups. Measurements will include the angle of muscle reaction at fast stretch (R1), passive range of motion at slow stretch (R2), and the dynamic component of spasticity calculated as R2 minus R1, expressed in degrees. Quality of muscle reaction will also be recorded where applicable. The same designated index limb will be assessed longitudinally at all study time points.
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