N/A
N=30
Movement Enhancing Device for Children
Upper Extremity Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01959581 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in Time Contacting Objects — 40.75 percentage of time — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Movement Enhancing Device (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Time Contacting Objects |
40.75 | <.05 sig |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01959581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.