Movement Enhancing Device for Children

June 6, 2017 updated by: University of Delaware

An Innovative Device for Intervention in Infants With Nervous System Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Services
      • Newark, Delaware, United States, 19716
        • University of Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Movement enhancing device
Guided play while wearing a movement assisting device
Device: Movement Enhancing Device
Naturalistic play activities using the hands while wearing the movement enhancing device.
Other Names:
  • WREX (Wilmington Robotic Exoskeleton)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time Contacting Objects
Time Frame: 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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Collaborators

Christiana Care Health Services
Alfred I. duPont Hospital for Children

Investigators

  • Principal Investigator: Michele A Lobo, PT, PhD, University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R21HD076092-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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