Movement Enhancing Device for Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Delaware
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Information provided by (Responsible Party):
University of Delaware Identifier:
First received: October 8, 2013
Last updated: December 11, 2014
Last verified: December 2014
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.

Condition Intervention
Upper Extremity Dysfunction
Device: Movement Enhancing Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Innovative Device for Intervention in Infants With Nervous System Injury

Resource links provided by NLM:

Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • Increased time contacting objects [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 30
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: WREX (Wilmington Robotic Exoskeleton)

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.

Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01959581

Contact: Michele A Lobo, PT, PhD 302-831-3214

United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: David Paul, MD    302-733-2410   
Sub-Investigator: David Paul, MD         
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Contact: Michele A Lobo, PT, PhD    302-831-3214   
Principal Investigator: Michele Lobo, PT, PhD         
Sub-Investigator: James C Galloway, PT, PhD         
Nemours Foundation Recruiting
Wilmington, Delaware, United States, 19803
Contact: Tariq Rahman, PhD    302-651-6831   
Principal Investigator: Tariq Rahman, PhD         
Sponsors and Collaborators
University of Delaware
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Principal Investigator: Michele A Lobo, PT, PhD University of Delaware
  More Information

No publications provided

Responsible Party: University of Delaware Identifier: NCT01959581     History of Changes
Other Study ID Numbers: 1R21HD076092-01A1 
Study First Received: October 8, 2013
Last Updated: December 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Delaware:
Wilmington Robotic Exoskeleton
Upper extremity function
Preterm Infants
Brain injury
Early Intervention

Additional relevant MeSH terms:
Musculoskeletal Diseases processed this record on February 07, 2016