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Movement Enhancing Device for Children

Not Applicable
Completed
Conditions
Upper Extremity Dysfunction
Interventions
Device: Movement Enhancing Device
Registration Number
NCT01959581
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Movement enhancing deviceMovement Enhancing DeviceGuided play while wearing a movement assisting device
Primary Outcome Measures
NameTimeMethod
Change in Time Contacting Objects7 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Christiana Care Health Services

🇺🇸

Newark, Delaware, United States

Nemours Foundation

🇺🇸

Wilmington, Delaware, United States

University of Delaware

🇺🇸

Newark, Delaware, United States

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