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临床试验/NCT05144373
NCT05144373已完成不适用

Role of Early Motor Experience in Infants With Down Syndrome

Georgia State University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Bayley language scores

研究概览

简要总结

Infants with Down syndrome show significant delays and weaknesses in motor, cognitive, and language development compared to typically developing infants. This project aims to examine the developmental cascade effects of specific gross and fine motor experience on motor, cognitive and language development in infants with Down syndrome. We propose that both gross and fine motor experience will facilitate cognitive and language development in infants with Down syndrome, and particularly, fine motor experience will help advance gesture and early words production.

详细描述

Down syndrome (DS) is the most common genetic condition and causes significant development delays and weaknesses in the motor, cognitive, and language domains. It is important to study these co-occurring developmental challenges and develop effective intervention strategies for positive learning outcomes in multiple domains simultaneously. It was found that motor development is closely associated with cognitive and language development in typically developing infants and advances in motor development have developmental cascade effects on other domains. However, this interrelation has not been studied in infants with DS. Our prior work has shown that gross motor experience through body-weight-supported treadmill stepping leads to an earlier onset of walking and improves subsequent locomotor ability in infants with DS. However, we do not yet know the extent to which this motor experience advances cognitive and language development in infants with DS. Research also suggests that grasping, a major fine motor skill emerging in infancy, provides the needed scaffolding for subsequent gesture and speech production. However, research on grasping and its potential effects on other domains in infants with DS remains scarce. The objectives of this proposal are to understand: the role of (a) specific gross motor experience and (b) specific fine motor experience on the motor, cognitive and language development of infants with DS. Our central hypothesis is that motor (both gross and fine) experience will help advance cognitive and language development in infants with DS. We will recruit 45 infants with DS from the greater Atlanta area and beyond. There will be three groups: (a) gross motor (GM) group (n=15), entering the study at about 10 months of age; (b) gross motor plus fine motor (GM+FM) group (n=15), entering the study at about 10 months; and (c) control group (n=15), entering the study at about 20 months. Aim 1: Determine the effects of gross motor experience on cognitive and language development in infants with DS, comparing the GM and control groups. Only the GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age (T1) until onset of walking. We hypothesize that the GM group will show higher Bayley scores and better gesture and word production at termination of the GM intervention (T3) and five months thereafter (T4) than the control group. Aim 2: Determine the effects of fine motor experience on cognitive and language development in infants with DS who receive the GM intervention, particularly in gesture and word production, comparing the GM and GM+FM groups. Only the GM+FM group will receive fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. We hypothesize that the GM+FM group will show further improvements in motor, cognitive and language domains, particularly in gesture and word production, than the GM group at termination of the FM intervention (T2) and again at T3 and T4. Our study will gain an in-depth understanding of the cascading effects of motor experience on cognitive and language development and lay the groundwork for future clinical trials in infants with DS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • An appropriate age range of 7-36 months
  • A diagnosis of Down syndrome.

排除标准

  • The presence of seizure disorders
  • Non-correctable vision, hearing and heart problems
  • Any other severe medical conditions that may prevent the infant from participating in this study

结局指标

主要结局

Bayley language scores

时间窗: 25 months for all three groups

The Bayley Scale of Infant and Toddler Development language composite scores

Gesture production

时间窗: 25 months for all three groups

It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction

Bayley cognitive scores

时间窗: 25 months for all three groups

The Bayley Scale of Infant and Toddler Development cognitive composite scores

次要结局

  • Bayley motor scores(25 months for all three groups)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianhua Wu

Professor

Georgia State University

研究点 (2)

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