The Efficacy of Constraint Induced Movement Therapy for Babies (Baby-CIMT) in Infants Below 12 Month With Risk of Developing Unilateral Cerebral Palsy, a Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Hand Assessment for Infants (HAI)
研究概览
简要总结
A randomized control trial investigating if an early intervention program of modified Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age will improve hand function in children with risk for developing cerebral palsy.
详细描述
The investigators hypothesis is that Baby-CIMT including intensive specific task oriented training is more preferable than general stimulation which is the assumption for baby massage used in the control group. The intervention protocol is developed at Astrid Lindgren Children hospital, Stockholm Sweden.
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)
入排标准
- 年龄范围
- 3 Months 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A neonatal history of different origin of events affecting the brain, preterm children with predominantly unilateral hemorrhage, venous infarction or with matter lesion or pre, perinatal or early postnatal stroke or Infants referred to the hospital/rehabilitation centers/specialists with signs of asymmetries before 8 month of age, likely to be diagnosed with unilateral cerebral palsy at later age.
- •Recruitment criteria of child characteristics
- •Age can vary, earliest at 3 months of age and at the latest at 8 months
- •Sign of asymmetries from mild to clear and severe asymmetries,
排除标准
- •Severe visual impairment Seizures not controlled by drugs Not unilateral CP at 12 month
研究组 & 干预措施
Baby-CIMT
The infants will be prevented from using the preferred hand while the other hand will be trained using amusing and easily handled toys.
干预措施: Baby-CIMT (Behavioral)
baby-massage
The infants will receive baby massage
干预措施: Baby-Massage (Behavioral)
结局指标
主要结局
Hand Assessment for Infants (HAI)
时间窗: 12 month post term age
Hand Assessment for Infants (HAI) identify and measure upper limb asymmetry and general manual development from 3-12 month in children at risk of developing cerebral palsy.Even though our Primary Outcome Measure is when children are at one year post term age, we are going to publish results from assessments at earlier ages to measure changes after each intervention period.
次要结局
- Alberta Motor Infant Scale(Baseline and12 months post term age)
研究者
Ann-Christin Eliasson
professor
Karolinska Institutet