Flexible Electronics for Early Assessment

April 29, 2022 updated by: Eugene Goldfield, Wyss Institute at Harvard University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Wyss Institute for Biologically Inspired Engineering at Harvard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
Term
No Intervention: Group 2
Preterm
Experimental: Group 3
Term
Device: FlexiMitt
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.
Experimental: Group 4
Preterm
Device: FlexiMitt
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Design and Fabricate FlexiMitts
Time Frame: Anticipated Year 1
To measure joint angles and force
Anticipated Year 1
Demonstrate Safety
Time Frame: Anticipated Year 1
Bench tests of material failure (i.e., stretch deformity and compositional integrity)
Anticipated Year 1
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
Anticipated Year 2 through 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
Anticipated Year 2 through 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyss Institute at Harvard University

Collaborators

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

Investigators

  • Principal Investigator: Eugene Goldfield, Ph.D., Wyss Institute for Biologically Inspired Engineering

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2017

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCD-CS-0001
  • 1R01HD090985-01 (U.S. NIH Grant/Contract)
  • IRB16-1008 (Other Identifier: Harvard Longwood Medical Area IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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