Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Hammersmith Neonatal/Infant Neurological Examination
研究概览
简要总结
This project focuses on motor development, muscle growth and muscle activity. Using advanced, instrumented tests such as , the link between muscles and the movement characteristics will be studied. In addition, the evolution of these neuro-biomechanical determinants during the first year of life will be investigated. The examinations are planned for a group of high-risk infants (e.g. premature birth, cases of asphyxia, etc.) compared with a group of infants with typical development.
详细描述
Background and rationale:
Prematurity and the associated causes of perinatal brain damage, as well as neonatal stroke and birth asphyxia, are major risk factors for neurodevelopmental disorders appearing from birth. In addition, these neuromotor disorders resulting from impaired brain development appear progressively over the course of the first year, affecting early movement and muscle growth. Therefore, early diagnosis and motor therapy are essential to improve long-term neurodevelopmental outcomes. However, in order to provide adequate strategies for these high-risk infants, it is crucial to identify the determinants of potential neuromotor deficits and their consequences on early motor behavior and developmental trajectory during the first year of life. A multimodal tool is needed to reveal the early neuro-biomechanical determinants of motor behavior in infants at high risk of neurodevelopmental disorders.
Objective(s):
- Establishing a comprehensive multimodal tool for the assessment of neuro-biomechanical determinants of motor behavior in the first year of life in high-risk infants for neurodevelopmental impairments, further referred to as "advanced muscle and movement analysis (AMMA)"
- Revealing early neuro-biomechanical determinants in high-risk infants covering the first year of life, including the time points in the neonatal period, at term age, at 3 months of (corrected) age, at 6 months of (corrected) age and at 12 months of (corrected) age, by using the AMMA
Outcome(s):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Weeks 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hammersmith Neonatal/Infant Neurological Examination
时间窗: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
Neurological assessment for different domains such as muscle tone, postures, movements and reflexes . Resulting in total scores (0-78) which can be compared to norm values, and higher scores indicate better outcome.
Change in muscle morphology size
时间窗: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
The size of the lower leg muscles defined by freehand ultrasound
Change in muscle morphology length
时间窗: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
The length of the lower leg muscles defined by freehand ultrasound
General Movement Assessment
时间窗: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age
Observation of general movements following the Prechtl's General Movement Assessment, interpreted by observing age-specific general movement components and extracting the Motor Optimality Score (0-12, the higher, the better outcome)
Change in muscle activity
时间窗: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
Investigation of the muscle activity during spontaneous, whole body movements by using surface electromyography.
Change in motor behaviour
时间窗: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
Investigation movement quality/quantify during spontaneous, whole body movements by using reflective markers.
次要结局
- Bayley Scales of Infant and Toddler Development - Version III(3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.)
- Magnetic resonance imaging of the brain: classification(up to 4 weeks post-term age)
- Magnetic resonance imaging of the brain: quantification(up to 4 weeks post-term age)
- Alberta Infant Motor Scale (AIMS)(3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.)
研究者
Stephane ARMAND
Professor
University Hospital, Geneva