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Movement Enhancing Device for Children

This study has been completed.
Sponsor:
Collaborators:
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Information provided by (Responsible Party):
University of Delaware
ClinicalTrials.gov Identifier:
NCT01959581
First received: October 8, 2013
Last updated: June 6, 2017
Last verified: June 2017
  Purpose
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 Intervention
Upper Extremity Dysfunction Device: Movement Enhancing Device

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: May 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959581

Locations
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
Investigators
Principal Investigator: Michele A Lobo, PT, PhD University of Delaware
  More Information

Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT01959581     History of Changes
Other Study ID Numbers: 1R21HD076092-01A1 ( U.S. NIH Grant/Contract )
Study First Received: October 8, 2013
Results First Received: February 6, 2017
Last Updated: June 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 19, 2017