tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Assisting Hand Assessment
研究概览
简要总结
The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants and care providers will not be told of their group allocation. Participants in the sham group will receive a brief stimulation of the scalp, which will give them a feeling of being stimulated. This sham stimulation has been shown to effectively blind participants to group. Assessors will not be told the type of study being conducted.
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
- •Diagnosis of congenital hemiplegic cerebral palsy
- •Ability to lift and grasp light objects with affected hand
- •Ability to extend wrist of affected hand 15 degrees
- •Ability to follow instructions and provide informed assent
- •Parent(s) able to provide informed consent
排除标准
- •Seizures after age 2 years
- •Spasticity medication within 6 months before study
- •Selective dorsal rhizotomy
- •Surgery in affected upper extremity within year before study
结局指标
主要结局
Change in Assisting Hand Assessment
时间窗: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Measure of how well the child uses both hands cooperatively for bimanual activities
次要结局
- Jebsen-Taylor Test of Hand Function(Day before intervention begins, compared to day after intervention ends (six days after intervention begins))
- Box and Blocks test(Day before intervention begins, compared to day after intervention ends (six days after intervention begins))