Movement Enhancing Device for Children
- 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
• 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
• 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
Group Intervention Description Movement enhancing device Movement Enhancing Device Guided play while wearing a movement assisting device
- Primary Outcome Measures
Name Time Method Change in Time Contacting Objects 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.
- Secondary Outcome Measures
Name Time Method
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