Flexible Electronics for Early Assessment

Status:	Recruiting
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	Any
Updated:	6/28/2018
Start Date:	August 2, 2017
End Date:	January 2021
Contact:	Eugene Goldfield, Ph.D.
Email:	Eugene.goldfield@childens.harvard.edu
Phone:	617-355-8353

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

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.

Inclusion Criteria:

Very Low Birth Weight (VLBW) Infants 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 participate in testing

- Otherwise healthy condition

VLBW Infants Longitudinal Study:

- Ages 13-60 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 13-60 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 participate in testing

Healthy Infants Longitudinal Study:

- Ages 13-60 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 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 participate

We found this trial at

sites

Wyss Institute for Biologically Inspired Engineering at Harvard University

Boston, Massachusetts 02115

Phone: 617-355-8353

from

Boston, MA