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Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

2013年8月25日 更新者:Brian McCrindle、The Hospital for Sick Children
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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

20

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5G 1X8
        • The Hospital for Sick Children

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 2年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:All Subjects
A total of 20 children and their parents will be recruited for this study. Ten children will have had the Glenn procedure and 10 infants will have had the arterial switch operation.
Participation in the study will require the parent and child to attend two assessment visits in addition to completing a series of parent and infant activities on a daily basis throughout the 10-week intervention period. The parent-led activities will include activities such as walking with the child, stacking blocks, rolling a ball to the child, hiding a toy under a blanket for the child to find, encouraging the child to kick a rattle while the child is lying on his/her back, or crawling or rolling in different directions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales
大体时间: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.
Baseline and four months

次要结果测量

结果测量
措施说明
大体时间
Parents opinion on the home-based neurodevelopmental rehabilitation programme
大体时间:at 4 months
During the final assessment, the researcher will interview the parent to obtain their perspective on delivering the study activities at home.
at 4 months
Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme
大体时间:at 4 months
Research students participating in this project will also be interviewed regarding their experiences and perceptions of guiding a home-based, parent-delivered rehabilitation programme.
at 4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Brian McCrindle, MD、The Hospital for Sick Children, Toronto Canada

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年10月1日

初级完成 (实际的)

2010年6月1日

研究完成 (实际的)

2010年6月1日

研究注册日期

首次提交

2010年11月10日

首先提交符合 QC 标准的

2010年11月10日

首次发布 (估计)

2010年11月11日

研究记录更新

最后更新发布 (估计)

2013年8月27日

上次提交的符合 QC 标准的更新

2013年8月25日

最后验证

2013年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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