Flexible Electronics for Early Assessment

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infant
• Interventions: Device: FlexiMitt

• Registration Number: NCT03034785
• Lead Sponsor: Wyss Institute at Harvard University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Study Start: 2017-08-02
• Status Verified: 2020-05
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	FlexiMitt	Term
Group 4	FlexiMitt	Preterm

Primary Outcome Measures

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

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Wyss Institute for Biologically Inspired Engineering at Harvard University; 🇺🇸 Boston, Massachusetts, United States