Upper Extremity Dysfunction Clinical Trial
Official title:
An Innovative Device for Intervention in Infants With Nervous System Injury
Verified date | October 2016 |
Source | University of Delaware |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Month to 6 Years |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Christiana Care Health Services | Newark | Delaware |
United States | University of Delaware | Newark | Delaware |
United States | Nemours Foundation | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Delaware | Alfred I. duPont Hospital for Children, Christiana Care Health Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased time contacting objects | Increased success interacting with objects in a standardized midline reaching assessment noted by increased percentage of assessment time with the hand(s) contacting the object | 7 months | No |
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