Flexible Electronics for Early Assessment

NCT03034785 | Completed FDA Device

• 3 other identifiers: LCD-CS-00011R01HD090985-01IRB16-1008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Very Low Birth Weight Infant

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Group 1

NO INTERVENTION

Term

Group 2

NO INTERVENTION

Preterm

Group 3

EXPERIMENTAL

Term

Device: FlexiMitt

Group 4

EXPERIMENTAL

Preterm

Device: FlexiMitt

Interventions

FlexiMitt DEVICE

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.

Group 3; Group 4

Eligibility Criteria

• Age: 13 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyss Institute at Harvard University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Wyss Institute for Biologically Inspired Engineering at Harvard University

Boston, Massachusetts, 02115, United States

Location

Related Publications (24)

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  BACKGROUND

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  BACKGROUND

• Chen YP, Keen R, Rosander K, von Hofsten C. Movement planning reflects skill level and age changes in toddlers. Child Dev. 2010 Nov-Dec;81(6):1846-58. doi: 10.1111/j.1467-8624.2010.01514.x.

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  BACKGROUND

Study Officials

• Eugene Goldfield, Ph.D.

  Wyss Institute for Biologically Inspired Engineering

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology in Psychiatry

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 27, 2017
• Study Start: August 2, 2017
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 3, 2022

Record last verified: 2020-05

Locations

US (2)