Effects of Transcranial Direct Current Stimulation in Addition to Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Pediatric Balance Scale Total Score
研究概览
简要总结
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.
详细描述
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 on balance and executive functions in children with spastic diplegic cerebral palsy. The active intervention will be compared with sham tDCS combined with the same VR rehabilitation and with conventional physical therapy.
Forty-two children aged 8-16 years with spastic diplegic cerebral palsy and Gross Motor Function Classification System (GMFCS) levels I-III will be enrolled and randomly allocated in a 1:1:1 ratio, with 14 participants in each intervention arm. Outcome assessment will be performed by an assessor blinded to group allocation.
Participants in the active tDCS plus VR group will receive transcranial direct current stimulation at an intensity of 1 mA for 20 minutes per session using saline-soaked sponge electrodes, together with structured VR rehabilitation. The stimulation montage will target the lower-limb motor cortical region with a supraorbital reference electrode. Participants in the sham tDCS plus VR group will receive the same electrode setup and VR rehabilitation programme; sham stimulation will be delivered for the initial 30 seconds to reproduce the early sensory experience of active stimulation without continued therapeutic stimulation.
VR rehabilitation will include progressively challenging activities targeting postural control, balance, movement coordination, obstacle navigation, dual-task performance, visual attention, and cognitive-motor integration. Participants in the conventional physical therapy group will receive a structured rehabilitation programme incorporating lower-limb stretching, strengthening, balance training, gait-related activity, motor-control exercises, and progressive functional mobility training.
All groups will receive 18 sessions over six weeks at a frequency of three sessions per week. Assessments will be conducted before treatment at baseline (S0), after nine treatment sessions at the midpoint of the programme (S9), and after completion of 18 sessions (S18).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments will be performed by an assessor who is blinded to participant group allocation. Participants assigned to the active and sham tDCS groups will undergo the same electrode placement and virtual reality rehabilitation protocol. The sham condition will mimic the initial sensation of active stimulation; however, because the conventional physical therapy arm involves a visibly different intervention, participant masking will not apply across all three study groups.
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active tDCS + Virtual Reality
participants will receive active transcranial direct current stimulation at 1 mA for 20 minutes combined with virtual reality rehabilitation, three sessions per week for six weeks, for a total of 18 sessions.
干预措施: Active Transcranial Direct Current Stimulation (Device)
Active tDCS + Virtual Reality
participants will receive active transcranial direct current stimulation at 1 mA for 20 minutes combined with virtual reality rehabilitation, three sessions per week for six weeks, for a total of 18 sessions.
干预措施: Virtual Reality Rehabilitation (Behavioral)
Sham tDCS + Virtual Reality
Participants will receive sham transcranial direct current stimulation using the same electrode setup as the active condition, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks, for a total of 18 sessions.
干预措施: Sham Transcranial Direct Current Stimulation (Device)
Sham tDCS + Virtual Reality
Participants will receive sham transcranial direct current stimulation using the same electrode setup as the active condition, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks, for a total of 18 sessions.
干预措施: Virtual Reality Rehabilitation (Behavioral)
Conventional Physical Therapy
Participants will receive conventional physical therapy including lower-limb stretching, strengthening, balance training, motor-control exercises, gait-related training, and functional mobility activities, three sessions per week for six weeks.
干预措施: Conventional Physical Therapy (Behavioral)
结局指标
主要结局
Pediatric Balance Scale Total Score
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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.
Digit Span Test Raw Scores
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
Attention, short-term memory, and working memory will be assessed using the Digit Span Test. Raw scores will be recorded for Digit Span Forward, Digit Span Backward, Digit Span Sequencing, and the overall Digit Span Total Score. Higher raw scores indicate better attention and working-memory performance.
次要结局
- Modified Tardieu Scale(Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6))
研究者
Waqar Ahmed Awan
Head OF Department
Riphah International University