Effects of Transcranial Direct Current Stimulation in Addition to Virtual Reality on Gait and Self-Esteem in Children With Spastic 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
- 10-Meter Walk Test Self-Selected Walking Velocity
研究概览
简要总结
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.
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 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).
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
Experimental: 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)
Experimental: 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 Comparator: Sham tDCS + Virtual Reality
Participants will receive sham transcranial direct current stimulation using the same electrode setup, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks.
干预措施: Sham Transcranial Direct Current Stimulation (Device)
Sham Comparator: Sham tDCS + Virtual Reality
Participants will receive sham transcranial direct current stimulation using the same electrode setup, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks.
干预措施: Virtual Reality Rehabilitation (Behavioral)
Active Comparator: Conventional Physical Therapy
Participants will receive conventional physical therapy including stretching, strengthening, balance training, gait training, and functional mobility exercises, three sessions per week for six weeks.
干预措施: Conventional Physical Therapy (Behavioral)
结局指标
主要结局
10-Meter Walk Test Self-Selected Walking Velocity
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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
时间窗: Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6)
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.
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))
- GMFM-88(Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6))
- Functional Mobility Scale - 5 m, 50 m, and 500 m(Baseline (Week 0), after 9 treatment sessions (approximately Week 3), and after 18 treatment sessions (approximately Week 6))
- PEDI-CAT functional domains(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