Movement Enhancing Device for Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01959581
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Information provided by (Responsible Party):
University of Delaware

Brief Summary:
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device.

Condition or disease Intervention/treatment
Upper Extremity Dysfunction Device: Movement Enhancing Device

Detailed Description:
Certain conditions or diagnoses identified soon after birth are known to put infants at risk for having problems with their motor (movement) development as they get older. Infants with these diagnoses are at risk for additional developmental problems due to their inability to move their bodies to explore, learn, and play. This study tests how a device that assists movement can help exploration, learning, and play in children. The information gathered in this study will help us better understand how early learning happens and how we can help individuals become better movers, learners, and problem-solvers so they can increase their participation in everyday play activities.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Coders are blind to which study phase participants are in
Primary Purpose: Treatment
Official Title: An Innovative Device for Intervention in Infants With Nervous System Injury
Study Start Date : May 2014
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Movement enhancing device
Guided play while wearing a movement assisting device
Device: Movement Enhancing Device
Naturalistic play activities using the hands while wearing the movement enhancing device.
Other Name: WREX (Wilmington Robotic Exoskeleton)

Primary Outcome Measures :
  1. Change in Time Contacting Objects [ Time Frame: 7 months ]
    Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

• Infants will be invited to participate if they are between 1 month and 6 years and:

  • Were born < 36 weeks of gestational age with periventricular leukomalacia or grade III or IV intraventricular hemorrhage
  • Were born > 36 weeks of gestational age with encephalopathy related to perinatal asphyxia
  • Have the diagnosis of neonatal stroke or intracranial hemorrhage
  • Have brachial plexus palsy
  • Have arthrogryposis multiplex congenital
  • Have Down syndrome
  • Have congenital hypotonia

Exclusion Criteria:

• blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01959581

United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
University of Delaware
Newark, Delaware, United States, 19716
Nemours Foundation
Wilmington, Delaware, United States, 19803
Sponsors and Collaborators
University of Delaware
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Principal Investigator: Michele A Lobo, PT, PhD University of Delaware

Responsible Party: University of Delaware Identifier: NCT01959581     History of Changes
Other Study ID Numbers: 1R21HD076092-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2013    Key Record Dates
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Delaware:
Wilmington Robotic Exoskeleton
Upper extremity function
Preterm Infants
Brain injury
Early Intervention

Additional relevant MeSH terms:
Musculoskeletal Diseases