Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy

This study is a three-arm, parallel-group, randomized controlled trial designed to evaluate the effects of active transcranial direct current stimulation (tDCS) combined with virtual reality (VR) rehabilitation in children with spastic cerebral palsy. The study will compare active tDCS plus VR with sham tDCS plus an identical VR protocol and with conventional physical therapy.

Forty-two children with spastic diplegic cerebral palsy, aged 8-16 years and classified within Gross Motor Function Classification System (GMFCS) levels I-III, will be enrolled. Eligible participants will be randomly allocated in a 1:1:1 ratio, with 14 participants assigned to each treatment group. Outcome assessment will be performed by an assessor blinded to treatment allocation.

Participants in all three groups will complete 18 treatment sessions over six weeks at a frequency of three sessions per week. The active tDCS plus VR group will receive low-intensity tDCS at 1 mA for 20 minutes per session in combination with a structured VR-based rehabilitation programme. The VR programme will include progressively challenging activities directed toward postural control, balance, coordination, gait-related activity, and cognitive-motor integration.

Participants in the sham tDCS plus VR group will undergo the same electrode setup and VR rehabilitation programme. Sham stimulation will be delivered briefly at the beginning of the session to reproduce the initial sensations of stimulation without providing continued active cortical stimulation. Participants allocated to conventional physical therapy will receive a structured rehabilitation programme incorporating stretching, lower-limb strengthening, balance training, gait training, functional mobility exercises, and progressive task-specific practice.

Assessments will be conducted at baseline before the intervention (S0), after nine treatment sessions at the midpoint of the programme (S9), and following completion of 18 treatment sessions (S18).

The co-primary outcomes will be gait performance, assessed using the 10-Meter Walk Test, and self-esteem, assessed using the child version of the Rosenberg Self-Esteem Scale. Secondary outcome domains will include spasticity assessed using the Modified Tardieu Scale, gross motor function assessed using the Gross Motor Function Measure-88, functional mobility assessed using the Functional Mobility Scale, and functional independence assessed using the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT).

The study is intended to determine whether active tDCS provides an additional therapeutic effect when combined with VR rehabilitation beyond the effects associated with VR training and sham stimulation, while also comparing the technology-assisted intervention with conventional physical therapy.

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.