Movement Enhancing Device for Children

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.

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Key information

Conditions

Upper Extremity Dysfunction Arthrogryposis Brain Diseases Brain Injuries Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Joint Diseases Muscular Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Services, Newark, Delaware, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Movement Enhancing Device

Device

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

Other names: WREX (Wilmington Robotic Exoskeleton)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

Alfred I. duPont Hospital for Children
Christiana Care Health Services

Registry information

Official study title

An Innovative Device for Intervention in Infants With Nervous System Injury

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Oct 10, 2013
Registry last updated: Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed