Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
研究概览
简要总结
- To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy.
- To determine the retention effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy, one-month follow-up across the five groups.
详细描述
- To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on
- gross motor function, gait, balance, mobility, dexterity, and spasticity.
- executive functions
- self-esteem.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This study uses a double-blind brain stimulation design with extended masking. Participants, caregivers, therapists delivering task-oriented training or virtual reality therapy, and all outcome assessors are blinded to the type of transcranial direct current stimulation (active or sham). Sham stimulation is delivered using an identical setup and produces the same initial scalp sensation as active stimulation but does not provide continuous current, thereby maintaining blinding. Only the trained research staff member responsible for programming the tDCS device is aware of stimulation assignment and is not involved in intervention delivery, outcome assessment, or data analysis.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-18 years.
- •Neurologist-confirmed spastic cerebral palsy.
- •GMFCS Levels I-III (mild to moderate motor impairment).
- •Ability to understand and follow simple instructions.
- •Medically stable (no planned major surgery; no recent adjustment of medications affecting cortical excitability).
- •Parental/guardian written informed consent and child assent.
排除标准
- •Active uncontrolled epilepsy or history of seizure in the last year.
- •Metal implants in the head or implanted medical/electrical devices (e.g., cochlear implants, ventriculoperitoneal shunts, pacemakers).
- •Significant visual or auditory impairments that would interfere with task performance.
- •Severe behavioral or cognitive difficulties that would prevent safe application of tDCS or training tasks.
- •Currently taking medications known to significantly alter cortical excitability (e.g., benzodiazepines, antiepileptics) if dosage is unstable.
- •Participation in other experimental neurorehabilitation or brain stimulation interventions within the last 6 months.
研究组 & 干预措施
Sham Transcranial direct current stimulation + Task-Oriented Training
Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.
干预措施: Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training (Device)
Group A: Active Anodal Transcranial direct current stimulation + Task-Oriented Training
Participants receive active anodal transcranial direct current stimulation (tDCS) applied concurrently with task-oriented training.
干预措施: Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training (Device)
Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.
干预措施: Active Anodal Transcranial Direct Current Stimulation + Virtual Reality (Device)
Sham Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
干预措施: Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality (Device)
Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
干预措施: Conventional Physiotherapy (Other)