An Innovative Device for Intervention in Infants With Nervous System Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Change in Time Contacting Objects
研究概览
简要总结
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device.
详细描述
Certain conditions or diagnoses identified soon after birth are known to put infants at risk for having problems with their motor (movement) development as they get older. Infants with these diagnoses are at risk for additional developmental problems due to their inability to move their bodies to explore, learn, and play. This study tests how a device that assists movement can help exploration, learning, and play in children. The information gathered in this study will help us better understand how early learning happens and how we can help individuals become better movers, learners, and problem-solvers so they can increase their participation in everyday play activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Coders are blind to which study phase participants are in
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants will be invited to participate if they are between 1 month and 6 years and:
- •Were born < 36 weeks of gestational age with periventricular leukomalacia or grade III or IV intraventricular hemorrhage
- •Were born > 36 weeks of gestational age with encephalopathy related to perinatal asphyxia
- •Have the diagnosis of neonatal stroke or intracranial hemorrhage
- •Have brachial plexus palsy
- •Have arthrogryposis multiplex congenital
- •Have Down syndrome
- •Have congenital hypotonia
排除标准
- •blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.
结局指标
主要结局
Change in Time Contacting Objects
时间窗: 7 months
Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.
次要结局
未报告次要终点