Wearable Sensors and Video Recording for Children (Birth to 24 Months) to Monitor Motor Development
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Six month clinical score estimation
研究概览
简要总结
The objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.
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
- 0 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals identified as potentially at risk of abnormal motor development due to a risk factor (for example, prematurity, neonatal hypoxic ischemic encephalopathy, or neonatal stroke) OR control individuals for whom normal motor development is expected.
- •Age: < 24 months of age
- •Legal guardian able and willing to give written consent and comply with study procedures.
- •In case of multiple pregnancies, only one child selected at random will participate in the research activities. Study staff will have no influence over the selection, besides any known medical condition automatically excluding the baby as listed in our
排除标准
- •Exclusion Criteria:
- •Any open wound or skin breakdown on the limbs or upper torso.
- •Missing or incomplete limbs (such as from amputation or congenital limb defects)
- •Legal guardian unable to give written consent and comply with study procedures.
结局指标
主要结局
Six month clinical score estimation
时间窗: 6 months
Error between true clinical test scores and scores estimated from sensor and video data, assessed at 6 month time-point.
Prediction of neuromotor outcome using sensor and video data from 3 month time-point
时间窗: 3 months
Sensitivity and specificity of algorithm (trained on sensor and video data from the 3 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition \[PDMS-2\])
Three month clinical score estimation
时间窗: 3 months
Error between true clinical test scores and scores estimated from sensor and video data, assessed at the 3 month time-point.
Prediction of neuromotor outcome using sensor and video data from 6 month time-point
时间窗: 6 months
Sensitivity and specificity of algorithm (trained on sensor and video data from the 6 month time-point) to predict neuromotor outcome at final study visit (as measured by the Peabody Developmental Motor Scales, second edition \[PDMS-2\])
次要结局
- Prediction of neuromotor outcome using Test of Infant Motor Performance (TIMP) scores(1-2 weeks, 1 month, 3 months)
- Prediction of neuromotor outcome using Alberta Infant Motor Scale (AIMS) scores(6 months, 9 months, 1 year)
- Clinical score estimation(1-2 weeks, 1 month, 9 months, 1 year, 2 years)
- Prediction of neuromotor outcome at 2 years using sensor and video data from the remaining time-points(1-2 weeks, 1 month, 9 months, 1 year, 2 years)
- Prediction of neuromotor outcome using General Movements Assessment (GMA) scores(1-2 weeks, 1 month, 3 months)
- Prediction of neuromotor outcome using Hammersmith Infant Neurological Examination (HINE) scores(6 months, 9 months, 1 year)
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab