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OpenTrials
Completed

NCT Number: NCT03034785

Flexible Electronics for Early Assessment

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.

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Key information

Conditions

Very Low Birth Weight Infant

Age range

13 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Design and Fabricate FlexiMitts

    Time frame: Anticipated Year 1

    To measure joint angles and force

  2. Demonstrate Safety

    Time frame: Anticipated Year 1

    Bench tests of material failure (i.e., stretch deformity and compositional integrity)

  3. Examine group differences between Groups 1 and 2

    Time frame: Anticipated Year 2 through 4

    To examine group differences in force modulation and joint angles

  4. Examine longitudinal differences between Groups 1 and 2

    Time frame: Anticipated Year 2 through 4

    To examine longitudinal changes in force modulation and joint angles at 24 and 30 months

Sponsors and collaborators

Lead sponsor

Wyss Institute at Harvard University

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2017
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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