Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Prechtl's General Movements Assessment (GMA) score
研究概览
简要总结
Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.
详细描述
For children with neurodevelopmental disabilities, early treatment in the first year of life improves long-term outcomes. However, the investigators are currently held back by inadequacies of available clinical tests to measure and predict impairment. Existing tests are hard to administer, require specialized training, and have limited long-term predictive value. There is a critical need to develop an objective, accurate, easy-to-use tool for the early prediction of long-term physical disability. The field of pediatrics and infant development would greatly benefit from a quantitative score that would correlate with existing clinical measures used today to detect movement impairments in very young infants. To realize a new generation of tests that will be easy to administer, the investigators will obtain large datasets of infants playing in an instrumented gym or simply being recorded while moving in a supine posture. Video and sensor data analyses will convert movement into feature vectors based on our knowledge of the problem domain. Our approach will use machine learning to relate these feature vectors to currently recommended clinical tests or other ground truth information. The power of this design is that algorithms can utilize many aspects of movement to produce the relevant scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants, male and female, between 0-6 months (Infants older than 6 months before initial enrollment will be excluded).
- •Infants with early brain injury (EBI):
- •Hydrocephalus
- •Hypoxic-ischemic encephalopathy (HIE)
- •Periventricular leukomalacia (PVL)
- •Intraventricular hemorrhage (IVH)
- •Healthy infants (controls):
- •o No history of early brain injury (EBI)
- •Infants without EBI/risk for future disability:
- •Infants without known brain injuries, but with a history of preterm birth less than 32-week gestation with significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.
排除标准
- 未提供
研究组 & 干预措施
Cross-sectional-150 infants (atypical vs typical)
Arm (Study)1: To assess the concurrent validity of a multimodal instrumented gym with existing clinical tools. Here, using 150 infants, we will focus on converting data from an instrumented gym into estimates of the standard clinical tests.
干预措施: PANDA Gym (Diagnostic Test)
Longitudinal cohort - 50 infants (atypical vs typical)
Arm (Study) 2: To discover the features related to long-term motor development. Here we will convert data collected longitudinally from 50 infants, using both instrumented gym and video recordings, into estimates standard clinical tests change over time and track features over developmental timescales.
干预措施: PANDA Gym (Diagnostic Test)
Cross-sectional-1500 infants (atypical vs typical)
Arm (Study) 3: To develop a computer vision-based algorithm to quantify infant motor performance from a single-camera video. Here using video data from 1200 infants, plus those gathered from Arm 1 and Arm 2, we will extract pose data from single-camera video recordings and convert these into kinematic features and relevant scores needed to classify infant movement.
干预措施: Mobile App (Other)
结局指标
主要结局
Prechtl's General Movements Assessment (GMA) score
时间窗: 5 months
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Hammersmith Infant Neurological Examination (HINE) score
时间窗: 5 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Ability to predict The Hammersmith Infant Neurological Examination (HINE) score
时间窗: 6 months
The regression R-squared resulting from regression algorithm to predict the Test of Infant Motor Performance (TIMP)
Ability to predict The Test of Infant Motor Performance (TIMP) score
时间窗: 6 months
The regression R-squared resulting from regression algorithm to predict the Test of Infant Motor Performance (TIMP)
Ability to predict the Alberta Infant Motor Scale (AIMS) score
时间窗: 6 months
The regression R-squared resulting from a regression algorithm to predict the Alberta Infant Motor Scale (AIMS) score
The Test of Infant Motor Performance (TIMP) score
时间窗: 4 months
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
Alberta Infant Motor Scale (AIMS) score
时间窗: 6 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Prechtl's General Movements Assessment (GMA) score
时间窗: 1 months
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Prechtl's General Movements Assessment (GMA) score
时间窗: 2 months
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Prechtl's General Movements Assessment (GMA) score
时间窗: 3 months
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
Prechtl's General Movements Assessment (GMA) score
时间窗: 4 months
The spontaneous movements of infants aged 1 to 5 months will be classified with the GMA. The GMA is a qualitative observational scale of infant movement. Normal infant movement is described as a writhing movement at earlier ages, characterized by small, circular and elegant movements, and fidgety movements at older ages.
The Test of Infant Motor Performance (TIMP) score
时间窗: 1 month
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
The Test of Infant Motor Performance (TIMP) score
时间窗: 2 months
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
The Test of Infant Motor Performance (TIMP) score
时间窗: 3 months
The TIMP, a test of infant movement designed to be used at term age and up to 16 weeks after, will be used to assess infants between 0 and 4 months.
Alberta Infant Motor Scale (AIMS) score
时间窗: 3 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Alberta Infant Motor Scale (AIMS) score
时间窗: 4 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Alberta Infant Motor Scale (AIMS) score
时间窗: 5 months
The AIMS is a quick motor screen that will be administered with infants 3,6 months of age.
Hammersmith Infant Neurological Examination (HINE) score
时间窗: 1 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
时间窗: 2 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
时间窗: 3 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
Hammersmith Infant Neurological Examination (HINE) score
时间窗: 4 months
The HINE, an examination of general infant neurological function and movement, will be administered with infants at all ages.
次要结局
- Toy contact time(6 months)
- Average Path Length(6 months)
- Toy contact frequency(6 month)
- Average Path Length(1 month)
- Toy contact time(1 month)
- Toy contact frequency(1 month)