Flexible Electronics for Early Assessment

Study Overview
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Brief Summary
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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.

Official Title
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Young Hands at Work and Play: Flexible Electronics for Early Assessment of Force Modulation and Planning in Children Born Prematurely

Conditions
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Very Low Birth Weight Infant

Intervention / Treatment
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* Device: FlexiMitt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>Term | |
| No Intervention: Group 2<br>Preterm | |
| Experimental: Group 3<br>Term | Device: FlexiMitt<br>* The proposed research designs and fabricates 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.<br>|
| Experimental: Group 4<br>Preterm | Device: FlexiMitt<br>* The proposed research designs and fabricates 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Design and Fabricate FlexiMitts | To measure joint angles and force | Anticipated Year 1 | 
| Demonstrate Safety | Bench tests of material failure (i.e., stretch deformity and compositional integrity) | Anticipated Year 1 | 
| Examine group differences between Groups 1 and 2 | To examine group differences in force modulation and joint angles | Anticipated Year 2 through 4 | 
| Examine longitudinal differences between Groups 1 and 2 | To examine longitudinal changes in force modulation and joint angles at 24 and 30 months | Anticipated Year 2 through 4 |