Movement-based Infant Intervention
Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90089
- Infant Neuromotor Control Laboratory
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Infants with congenital malformations of the legs will be excluded.
学习计划
研究是如何设计的?
设计细节
- 主要用途: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 |
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实验性的:Movement intervention
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.
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At each visit, the caregiver will be reminded of the infant's movement rate from the last visit.
The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time.
Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant.
The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
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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 |
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Movement Rate
大体时间:post intervention (intervention duration ranged from 2-6 months)
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leg movements produced per hour of awake time, assessed using wearable sensors
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post intervention (intervention duration ranged from 2-6 months)
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合作者和调查者
调查人员
- 首席研究员:Beth A Smith, PT, PhD、University of Southern California
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
Movement Intervention的临床试验
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University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的
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University of Southern CaliforniaNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child... 和其他合作者完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人