Young Hands at Work and Play: Flexible Electronics for Early Assessment of Force Modulation and Planning in Children Born Prematurely
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Design and Fabricate FlexiMitts
研究概览
简要总结
The morbidities associated with very low birth weight (VLBW) infants constitute a major health problem and a significant emotional and financial burden for families and our nation. The key to reducing this burden is early diagnosis. This research will be the first step towards intervention for cerebral growth and long-term neurodevelopmental morbidities of VLBW infants.
The proposed research is to design and fabricate a new technological innovation in wearable soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand (wrist and fingers) of toddlers. Building upon the investigators' ongoing work, they plan to engineer stretchable electronics for safe, toddler-scaled flexi-mitts to measure planning and force modulation.
The investigators' new flexi-mitt technology has the potential to provide a new diagnostic technology and the development of clinical assessment norms. With additional trials of the technology in large numbers of young children, it may be possible for clinicians and day care providers to eventually make measurements of planning and force modulation in play settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 13 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children Born Prematurely ("Preterm") -
- •Pilot Studies:
- •Ages 13-60 months (with the target ages around 18, 24, and 30 months)
- •Very low birth weight (less than 1500 grams)
- •Born between 28 and 33 weeks
- •Parent/Legal guardian provides written consent
- •Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)
- •Otherwise healthy condition
- •Longitudinal Study:
- •Ages 13-60 months (with the target age around 24 months) at the time of enrollment
- •Very low birth weight (less than 1500 grams)
- •Born between 28 and 33 weeks
- •Parent/Legal guardian provides written consent
- •Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)
- •Otherwise healthy condition
- •Typically Developing Children ("Term") -
- •Pilot Studies:
- •Ages 13-60 months (with the target ages around 18, 24, and 30 months)
- •Born at full term (37 weeks or later)
- •Healthy, with no history of neurological problems or musculoskeletal disorders, self-reported by parent or legal guardian
- •Parent/Legal guardian provides written consent
- •Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)
- •Longitudinal Study:
- •Ages 13-60 months (with the target age around 24 months) at time of enrollment
- •Born at full term (37 weeks or later)
- •Healthy, with no history of neurological problems or musculoskeletal disorders, self-reported by parent or legal guardian
- •Parent/Legal guardian provides written consent
- •Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)
排除标准
- •Both Preterm and Term
- •Child has a history of/or currently exhibits any severe neurological complications, such as perinatal intraventricular hemorrhage (Grade 3 or 4) or periventricular leukomalacia
- •The participant is a child of a PI or other IRB-approved study team member
- •Parent/legal guardian does not provide consent or is unwilling to facilitate testing with child
结局指标
主要结局
Design and Fabricate FlexiMitts
时间窗: Anticipated Year 1
To measure joint angles and force
Examine group differences between Groups 1 and 2
时间窗: Anticipated Year 2 through 4
To examine group differences in force modulation and joint angles
Demonstrate Safety
时间窗: Anticipated Year 1
Bench tests of material failure (i.e., stretch deformity and compositional integrity)
Examine longitudinal differences between Groups 1 and 2
时间窗: Anticipated Year 2 through 4
To examine longitudinal changes in force modulation and joint angles at 24 and 30 months
次要结局
未报告次要终点
研究者
Eugene Goldfield
Associate Professor of Psychology in Psychiatry
Wyss Institute at Harvard University