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临床试验/NCT03082313
NCT03082313已完成不适用

Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay

University of Southern California1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Movement Rate

研究概览

简要总结

The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. The intervention promotes movement experience from 3 months to sitting onset.

详细描述

Aim: Our purpose was to assess daily leg movement rate before and after a caregiver-provided in-home intervention for infants at risk for developmental disability. We also assessed adherence and quality of caregiver-child interaction.

Methods: Twelve infants, at risk for developmental disabilities, and their caregivers participated in an intervention focused on increasing leg movements. Intervention started between 3- and 6-months cor- rected age and ended once the infant was able to sit independently or at 9 months corrected age, whichever occurred first. Infants were assessed monthly.

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

入排标准

年龄范围
3 Months 至 9 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants will be 3 months of adjusted age at the first visit, +/- 10 days. Infants will be defined as at risk if they qualify for high risk infant follow up care as defined by California Children's Services.

排除标准

  • •Infants with congenital malformations of the legs will be excluded.

研究组 & 干预措施

Movement intervention

Experimental

The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time.

干预措施: Movement Intervention (Behavioral)

结局指标

主要结局

Movement Rate

时间窗: post intervention (intervention duration ranged from 2-6 months)

leg movements produced per hour of awake time, assessed using wearable sensors

次要结局

未报告次要终点

研究者

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

Beth A. Smith

Assistant Professor of Research

University of Southern California

研究点 (1)

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