Flexible Electronics for Early Assessment

Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034785
• Other study ID #: LCD-CS-0001
• Secondary ID: 1R01HD090985-01I
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: May 4, 2021

Study information

• Verified date: May 2020
• Source: Wyss Institute at Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infant

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Wyss Institute for Biologically Inspired Engineering at Harvard University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Wyss Institute at Harvard University	Beth Israel Deaconess Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (24)

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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. — View Citation

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Goldfield EC, Wolff PH. A dynamical systems perspective on infant action and it's development. Oxford Wiley-Blackwell; 2004

Gordon AM, Duff SV. Fingertip forces during object manipulation in children with hemiplegic cerebral palsy. I: anticipatory scaling. Dev Med Child Neurol. 1999 Mar;41(3):166-75. — View Citation

Jung WP, Kahrs BA, Lockman JJ. Manual action, fitting, and spatial planning: relating objects by young children. Cognition. 2015 Jan;134:128-39. doi: 10.1016/j.cognition.2014.09.004. Epub 2014 Oct 19. — View Citation

Lawn JE, Kinney M. Preterm birth: now the leading cause of child death worldwide. Sci Transl Med. 2014 Nov 19;6(263):263ed21. doi: 10.1126/scitranslmed.aaa2563. — View Citation

Majidi C, Kramer R, Wood RJ. A non-differential elastomer curvature sensor for softer-than-skin electronics. Smart Materials and Structures 20(10), 2011

Nordstrand L, Holmefur M, Kits A, Eliasson AC. Improvements in bimanual hand function after baby-CIMT in two-year old children with unilateral cerebral palsy: A retrospective study. Res Dev Disabil. 2015 Jun-Jul;41-42:86-93. doi: 10.1016/j.ridd.2015.05.003. Epub 2015 Jun 19. — View Citation

Park WL, Chen BR, Wood RJ. Design and fabrication of soft artificial skin using embedded micro channels and liquid conductors. IEEE Sensors Journal 12(8):2711-2718, 2012.

Park YL, Majidi C, Kramer R, Berard P, Wood RJ. Hyperelastic pressure sensing with a liquid-embedded elastomer. Journal of Micromechanics and Microengineering 20(12), 2010.

Rubens CE, Sadovsky Y, Muglia L, Gravett MG, Lackritz E, Gravett C. Prevention of preterm birth: harnessing science to address the global epidemic. Sci Transl Med. 2014 Nov 12;6(262):262sr5. doi: 10.1126/scitranslmed.3009871. Review. — View Citation

Santello M, Baud-Bovy G, Jörntell H. Neural bases of hand synergies. Front Comput Neurosci. 2013 Apr 8;7:23. doi: 10.3389/fncom.2013.00023. eCollection 2013. — View Citation

Slota GP, Latash ML, Zatsiorsky VM. Grip forces during object manipulation: experiment, mathematical model, and validation. Exp Brain Res. 2011 Aug;213(1):125-39. doi: 10.1007/s00221-011-2784-y. Epub 2011 Jul 7. — View Citation

Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sánchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23. — View Citation

Thelen E, Smith L. A dynamic systems approach to the development of cognition and action. Cambridge, MA: MIT Press 1994

Ulrich BD. Opportunities for early intervention based on theory, basic neuroscience, and clinical science. Phys Ther. 2010 Dec;90(12):1868-80. doi: 10.2522/ptj.20100040. Epub 2010 Oct 21. Review. — View Citation

Vogt D, Park YL, Wood RJ. Design and characterization of a soft multi-axis force sensor using embedded microfluidic channels. IEEE Sensors Journal 13(10):4056-4064, 2013

Yoshikawa T, Nagai K. Manipulating and grasping forces in manipulation by multifingered robot hands. IEEE Transactions on Robotics and Automation 7:67-77, 1991.

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Design and Fabricate FlexiMitts	To measure joint angles and force	Anticipated Year 1
Primary	Demonstrate Safety	Bench tests of material failure (i.e., stretch deformity and compositional integrity)	Anticipated Year 1
Primary	Examine group differences between Groups 1 and 2	To examine group differences in force modulation and joint angles	Anticipated Year 2 through 4
Primary	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