Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales
研究概览
简要总结
The purpose of this project is to investigate the feasibility of using a home-based, parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants who have had surgery for a complex heart defect.
详细描述
Neurodevelopmental deficits are a common morbidity among children who receive surgical treatment for complex congenital heart defects in infancy. Over 40% of children with complex heart defects will have neurodevelopmental deficits that persist throughout childhood even after a successful surgical procedure in infancy1. These deficits are typically related to basic motor perceptual motor or visual motor skills. Problems integrating what is seen (visual perceptions) with body movement (motor skills) makes it difficult for children to participate in peer play and limits their ability to succeed in school, thereby having a significant impact on the child's quality of life.
Traditional, therapist-delivered rehabilitation programmes to address these delays in neurodevelopment have not previously been attempted. It would be difficult to provide direct rehabilitation programmes to these patients given that their defects are rare and few patients are located within the same geographical area. Home-based, parent-delivered rehabilitation programmes have previously been shown to be effective at improving the motor skills of school-age children with complex heart defects5. Since a home-based parent delivered model would enable the participation of infants regardless of geographic location, the feasibility of using such a model for delivering neurodevelopmental rehabilitation should be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Families will be eligible to participate in this study if the child:
- •Had the arterial switch operation (for transposition of the great arteries) or has had a Glenn procedure (for functional single ventricle).
- •Is medically stable for normal infant activities.
- •Is between 12 and 24 months of age in January 2010.
排除标准
- •Families will be excluded from study participation if:
- •The child has a recognized syndrome or other disability affecting neurodevelopment.
- •The child has had a medical procedure in the 3 months preceding the baseline study assessment.
- •The cardiologist responsible for the child's care refuses to allow the child's participation.
- •The child performs substantially above age-appropriate developmental milestones during the initial assessment (in which case an intervention is unlikely to have a detectable additional benefit).
结局指标
主要结局
Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales
时间窗: Baseline and four months
The Peabody Development Motor Scale has demonstrated validity and reliability for children from birth to 5 years of age. Six subtests (reflexes, stationary, locomotion, object manipulation, grasping, visual-motor integration) yield gross, fine and total motor quotient scores.
次要结局
- Parents opinion on the home-based neurodevelopmental rehabilitation programme(at 4 months)
- Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme(at 4 months)
研究者
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children