Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Score of the Alberta Infant Motor Scale (AIMS) at month 9
研究概览
简要总结
this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.
详细描述
Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.
Intervention group:
- Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.
- Three evaluations of motor milestones at 9, 12, and 15 months old.
Control group:
1. Three evaluations of motor milestones at 9, 12, and 15 months old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded: spontaneous behavior of babies is evaluated, that doesn't depend of having knowledge of the intervention. Outcomes assessor doesn't know the evaluated baby group.
入排标准
- 年龄范围
- 1 Day 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy-term infants
- •Male and female
- •Apgar score of at least 7 in the first minute and at five minutes.
- •Natural or cesarean birth
- •Absence of congenital malformations or orthopedic injury
- •Absence of known congenital or genetic pathology
- •Normal neurological medical examination of the newborn at hospital discharge.
排除标准
- •Newborns who have required hospitalization before being enrolled.
- •Multiple births
结局指标
主要结局
Score of the Alberta Infant Motor Scale (AIMS) at month 9
时间窗: 9 months old
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.
Score of the Alberta Infant Motor Scale (AIMS) at month 15
时间窗: 15 months old
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.
Score of the Alberta Infant Motor Scale (AIMS) at month 12
时间窗: 12 months old
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.
次要结局
未报告次要终点
研究者
Luis Fernandez
Physical Therapist
Universidad San Jorge