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

Riphah International University42 enrolled

Overview

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.

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.

Interventions

Active Transcranial Direct Current StimulationDEVICE

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 StimulationDEVICE

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 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 RehabilitationBEHAVIORAL

Virtual 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 TherapyBEHAVIORAL

Conventional 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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.