Movement Enhancing Device for Children

Upper Extremity Dysfunction Clinical Trial

Official title:

An Innovative Device for Intervention in Infants With Nervous System Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959581
• Other study ID #: 1R21HD076092-01A1
• 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

• Musculoskeletal Diseases
• Upper Extremity Dysfunction

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