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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01959581
Other study ID # 1R21HD076092-01A1
Secondary ID
Status Completed
Phase N/A
First received October 8, 2013
Last updated October 19, 2016
Start date May 2014
Est. completion date October 2016

Study information

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

Clinical Trial 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.


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 information / eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Movement Enhancing Device
Naturalistic play activities using the hands while wearing the movement enhancing device.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
University of Delaware Alfred I. duPont Hospital for Children, Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

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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