Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- EEG (Alpha, Beta, Theta)
研究概览
简要总结
Experimental cross-sectional study of a single application (vojta therapy or massage) in preterm and non-preterm infants to test whether there are differences in brain activation and oxygenation that occur with both techniques between term and preterm infants.
Secondly, the brain activation and oxygenation produced by both physiotherapy techniques will be tested separately to establish comparisons between the two groups.
Finally, between 3 - 6 months, we will analyse whether there are changes in gaze fixation (eye tracker) in the 4 study arms to see if there are differences between term and preterm infants but also the differences between the immediate effectiveness of both techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
盲法说明
Invesigator will not know which infants are premature or not
入排标准
- 年龄范围
- 7 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •term and preterm babys
- •first month after birth
排除标准
- •intrumental delivery
- •pathology associated
研究组 & 干预措施
Preterm group 1
To analize the brain activation and oxigenation using the Vojta Therapy
干预措施: Vojta Therapy (Other)
Preterm Group 2
To analize the brain activation and oxigenation using massotherapy
干预措施: Massotherapy (Other)
Term group 1
To analize the brain activation and oxigenation using the Vojta Therapy
干预措施: Vojta Therapy (Other)
Term group 2
To analize the brain activation and oxigenation using massotherapy
干预措施: Massotherapy (Other)
结局指标
主要结局
EEG (Alpha, Beta, Theta)
时间窗: Change from Baseline brain activation at 3 months
Brain activation
NIRS
时间窗: Change from Baseline brain oxigenation at 3 months
Brain oxigenation
次要结局
- Eye tracker(Change from Baseline gaze fization at 6 months)
研究者
Rocío Llamas-Ramos
Associate Professor
University of Salamanca