Cerebral palsy can affect walking ability, muscle control, functional mobility, and psychosocial well-being in children. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may support motor learning, while virtual reality (VR) rehabilitation provides interactive, repetitive, and task-specific motor training.
This randomized controlled trial will investigate whether active tDCS combined with VR rehabilitation provides additional benefits compared with sham tDCS combined with the same VR rehabilitation and conventional physical therapy in children with spastic cerebral palsy.
A total of 42 children aged 8 to 16 years with spastic diplegic cerebral palsy and Gross Motor Function Classification System (GMFCS) levels I-III will be randomly assigned in a 1:1:1 ratio to one of three groups: active tDCS plus VR, sham tDCS plus VR, or conventional physical therapy. Each group will receive 18 treatment sessions over six weeks, with three sessions per week.
Outcomes will be assessed before treatment, after nine sessions, and after 18 sessions. The primary outcomes will be gait performance measured using the 10-Meter Walk Test and self-esteem measured using the Rosenberg Self-Esteem Scale. Secondary outcomes will evaluate spasticity, gross motor function, functional mobility, and functional independence.
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.
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.
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 early 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 a Microsoft Xbox console with Kinect motion tracking. The program will include progressive whole-body, balance, gait-related, coordination, navigation, and dual-task activities using Kinect Adventures. Training will progress through familiarization, cognitive-motor integration, and challenge/functional integration phases over six weeks. VR will be provided in both the active and sham tDCS groups for 18 sessions.
Conventional Physical Therapy
BehavioralConventional physical therapy will be delivered for 30 minutes per session, three sessions per week for six weeks, for a total of 18 sessions. Treatment will progress from lower-limb stretching, supported balance and weight shifting to strengthening, motor-control exercises, gait initiation, overground gait training, obstacle negotiation, and functional mobility activities. Exercise difficulty and therapist support will be progressed according to participant tolerance and functional ability.
10-Meter Walk Test Self-Selected Walking Velocity
Gait performance will be assessed using the 10-Meter Walk Test at a self-selected walking pace. Walking velocity will be expressed in meters per second (m/s), with higher values indicating faster walking performance. The measure will be collected at baseline, mid-intervention, and post-intervention.
Child Rosenberg Self-Esteem Scale Total Score
Global self-esteem will be assessed using the Child Rosenberg Self-Esteem Scale. The scale contains 10 items and produces a total score ranging from 0 to 30, with higher scores indicating greater self-esteem. The total score will be assessed at baseline, mid-intervention, and post-intervention.
Modified Tardieu Scale
Spasticity will be assessed using the Modified Tardieu Scale in the clinically affected lower-limb muscle groups. The assessment will include the quality of muscle reaction and the angles of muscle reaction (R1) and passive range of motion (R2). The dynamic component of spasticity will be calculated as R2 minus R1, expressed in degrees.
GMFM-88
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The instrument evaluates five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Dimension and total scores will be expressed as percentages, with higher scores indicating better gross motor function.
Functional Mobility Scale - 5 m, 50 m, and 500 m
Functional mobility will be assessed using the Functional Mobility Scale at 5-meter, 50-meter, and 500-meter distances, representing mobility in home, school, and community environments. Each distance is rated on a 1-to-6 scale according to the level of assistance or mobility device required, with higher scores indicating greater functional mobility.
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test Daily Activities Domain Scaled Score
Functional performance in daily activities will be assessed using the Daily Activities domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). The domain is reported as a scaled score ranging from 20 to 80. Higher scores indicate greater functional ability in daily activities and therefore a better outcome.
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Riphah International University
Lead sponsor
IIMC, Riphah International University, Pakistan
Collaborator
