Movement Enhancing Device for Children

NCT ID: NCT01959581

Last Updated: 2017-07-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Upper Extremity Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Coders are blind to which study phase participants are in

Study Groups

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Movement enhancing device

Guided play while wearing a movement assisting device

Group Type OTHER

Movement Enhancing Device

Intervention Type DEVICE

Naturalistic play activities using the hands while wearing the movement enhancing device.

Interventions

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Movement Enhancing Device

Naturalistic play activities using the hands while wearing the movement enhancing device.

Intervention Type DEVICE

Other Intervention Names

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WREX (Wilmington Robotic Exoskeleton)

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role collaborator

Alfred I. duPont Hospital for Children

OTHER

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele A Lobo, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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Christiana Care Health Services

Newark, Delaware, United States

Site Status

University of Delaware

Newark, Delaware, United States

Site Status

Nemours Foundation

Wilmington, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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1R21HD076092-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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