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Clinical Trials/NCT01959581
NCT01959581
Completed
N/A

An Innovative Device for Intervention in Infants With Nervous System Injury

University of Delaware3 sites in 1 country30 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Upper Extremity Dysfunction
Sponsor
University of Delaware
Enrollment
30
Locations
3
Primary Endpoint
Change in Time Contacting Objects
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
October 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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.

Study Sites (3)

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