The Pilot Study of Constraint Induced Movement Therapy(CIMT） Intervention in Children With Hemiplegic Cerebral Palsy After Botulism Toxin Injection in Preschool Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
研究概览
简要总结
To establish a pilot randomized, crossover study on applying 2 constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy after botulinum toxin injection during preschool education.
详细描述
This study was designed to be a pilot study on the use of 4-week 2-hours/day and 2-week 4-hours/day CIMT interventions in children with hemiplegic CP after a BoNT-A injection in preschool education, and compared the effects and psychological stress of CP children relative to the 2 CIMT programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemiplegic or quadriplegic CP children were under a regular rehabilitation program with BoNT-A injections. They were classified as Gross Motor Function Classification System level I and II, aged between 3 and 6 years old, with at least below average mentality, and were in mainstream preschool education; the extension of their hemiplegic wrist and metaphalangeal joint was greater than 10 degrees.
排除标准
- •Children were excluded if they (a) could not understand or cooperate with the CIMT program, (b) had joint contracture of an upper limb, and (c) could not actively extend their hemiplegic wrist.
结局指标
主要结局
change of Visual-motor integration in Peabody-Developmental Motor Scales(PDMSⅡ)
时间窗: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
hand function, from 0 to 144, higher scores mean a better outcome.
Change of Chinese Version of Pediatric Evaluation of Disability Inventory( PEDI-C)
时间窗: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
ADL, from 0 to 73, higher scores mean a better outcome.
Change of Caregiver-Teacher Report Form (C-TRF)-Diagnostic scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
时间窗: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
From 0 to 14, higher scores mean a worse outcome.
Change of Statistical Manual (DSM)-oriented scale of the Achenbach System of Empirically-Based Assessment (ASEBA)
时间窗: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT and 4 months after CIMT
From 0 to 14, higher scores mean a worse outcome.
change of Modified Ashworth Scale(MAS)
时间窗: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
change of spasticity, from 0 to 4, higher scores mean a worse outcome.
Change of grasping in Peabody-Developmental Motor Scales(PDMSⅡ)
时间窗: 1 month after Botox injection, shortly after CIMT intervention, 2 months after CIMT, and 4 months after CIMT
hand function. from 0 to 52, higher scores mean a better outcome.
Change of GAS(goal attainment scale)
时间窗: 1 month after Botox injection, 2 months after CIMT and 4 months after CIMT
GAS included 2 playing goals and 2 self-care goals.The goals were decided by the occupation therapist, the preschool teacher and the major caregiver. From (-2) to 2, higher scores mean a better outcome.
次要结局
未报告次要终点