Study Results
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Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2017-08-02
2021-05-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Group 1
Term
No interventions assigned to this group
Group 2
Preterm
No interventions assigned to this group
Group 3
Term
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.
Group 4
Preterm
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
* 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
13 Months
60 Months
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Beth Israel Deaconess Medical Center
OTHER
Wyss Institute at Harvard University
OTHER
Responsible Party
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Eugene Goldfield
Associate Professor of Psychology in Psychiatry
Principal Investigators
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Eugene Goldfield, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wyss Institute for Biologically Inspired Engineering
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Wyss Institute for Biologically Inspired Engineering at Harvard University
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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. No abstract available.
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.
Back SA. Cerebral white and gray matter injury in newborns: new insights into pathophysiology and management. Clin Perinatol. 2014 Mar;41(1):1-24. doi: 10.1016/j.clp.2013.11.001.
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. doi: 10.1017/s0012162299000353.
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, Sanchez 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.
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.
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.
Adolph KE, Berger SE, Leo AJ. Developmental continuity? Crawling, cruising, and walking. Dev Sci. 2011 Mar;14(2):306-18. doi: 10.1111/j.1467-7687.2010.00981.x.
Goldfield EC, Wolff PH. A dynamical systems perspective on infant action and it's development. Oxford Wiley-Blackwell; 2004
Thelen E, Smith L. A dynamic systems approach to the development of cognition and action. Cambridge, MA: MIT Press 1994
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.
Santello M, Baud-Bovy G, Jorntell H. Neural bases of hand synergies. Front Comput Neurosci. 2013 Apr 8;7:23. doi: 10.3389/fncom.2013.00023. eCollection 2013.
Eliasson AC, Gordon AM, Forssberg H. Basic co-ordination of manipulative forces of children with cerebral palsy. Dev Med Child Neurol. 1991 Aug;33(8):661-70. doi: 10.1111/j.1469-8749.1991.tb14943.x.
Forssberg H, Eliasson AC, Kinoshita H, Johansson RS, Westling G. Development of human precision grip. I: Basic coordination of force. Exp Brain Res. 1991;85(2):451-7. doi: 10.1007/BF00229422.
Yoshikawa T, Nagai K. Manipulating and grasping forces in manipulation by multifingered robot hands. IEEE Transactions on Robotics and Automation 7:67-77, 1991.
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.
Majidi C, Kramer R, Wood RJ. A non-differential elastomer curvature sensor for softer-than-skin electronics. Smart Materials and Structures 20(10), 2011
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
Endo Y, Tada M, Mochimaru M. Dhaiba: Development of Virtual Ergonomic Assessment System with Human Models Digital Human Modeling 1-8, 2014.
Benjamini Y, Hochberg Y. Controlling the false discovery rate: A practical and powerful approach to multiple testing. Journal of the Royal Statistical Society Series B (Methodological) 57(1):289-300, 1995.
Diggle P, Liang K-Y, Zeger SL. Analysis of longitudinal data. Clarendon Press; 1994.
Other Identifiers
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IRB16-1008
Identifier Type: OTHER
Identifier Source: secondary_id
LCD-CS-0001
Identifier Type: -
Identifier Source: org_study_id
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