Flexible Electronics for Early Assessment

Description

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. Additionally, the investigators plan to have the parent/guardian wear the gloves so they can determine the relative contributions of the child and the adult to the child's learning. In the same way that the adult assists learning to walk, they may assist in learning during play. The force data may be analyzed in the same way as the child's data. 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.

Study Start Date

August, 02 2017

Estimated Completion Date

January 2021

Interventions

  • Device: FlexiMitt

Study ID

Wyss Institute at Harvard University -- LCD-CS-0001

Status

Recruiting

Trial ID

NCT03034785

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

120

Sponsor

Wyss Institute at Harvard University

Inclusion Criteria

    Very Low Birth Weight (VLBW) Infants Pilot Studies:
  • Ages 13-36 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 participate in testing
  • Otherwise healthy condition VLBW Infants Longitudinal Study:
  • Ages 13-19 months (with the target age around 18 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 participate in testing
  • Otherwise healthy condition Healthy Infants Pilot Studies:
  • Ages 13-36 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 participate in testing Healthy Infants Longitudinal Study:
  • Ages 13-19 months (with the target age around 18 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 participate in testing Parent/Guardian • Must be a parent/guardian of child in Group 1 or Group 2

Exclusion Criteria

    Both Healthy and VLBW Infants
  • Child has a history of/or currently exhibits any severe neurological complications, such as perinatal germinal matrix hemorrhage or extensive periventricular leukomalacia (as verified by Dr. Vincent Smith)
  • 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 participate

Gender

All

Ages

13 Months to 36 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Vincent C Smith MD 617-667-3276 vsmith1@bidmc.harvard.edu
Wyss Institute for Biologically Inspired Engineering at Harvard University - Boston, Massachusetts 2.6 miles Eugene Goldfield PhD 617-355-8353 Eugene.Goldfield@childrens.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Vincent C Smith MD 617-667-3276 vsmith1@bidmc.harvard.edu
Wyss Institute for Biologically Inspired Engineering at Harvard University - Boston, Massachusetts 2.6 miles Eugene Goldfield PhD 617-355-8353 Eugene.Goldfield@childrens.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Vincent C Smith MD 617-667-3276 vsmith1@bidmc.harvard.edu
Wyss Institute for Biologically Inspired Engineering at Harvard University - Boston, Massachusetts 2.6 miles Eugene Goldfield PhD 617-355-8353 Eugene.Goldfield@childrens.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Vincent C Smith MD 617-667-3276 vsmith1@bidmc.harvard.edu
Wyss Institute for Biologically Inspired Engineering at Harvard University - Boston, Massachusetts 2.6 miles Eugene Goldfield PhD 617-355-8353 Eugene.Goldfield@childrens.harvard.edu

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