Movement Enhancing Device for Children
An Innovative Device for Intervention in Infants With Nervous System Injury
1 other identifier
interventional
30
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
July 6, 2017
CompletedJuly 6, 2017
June 1, 2017
2.4 years
October 8, 2013
February 6, 2017
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Time Contacting Objects
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
Study Arms (1)
Movement enhancing device
OTHERGuided play while wearing a movement assisting device
Interventions
Naturalistic play activities using the hands while wearing the movement enhancing device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Delawarelead
- Christiana Care Health Servicescollaborator
- Alfred I. duPont Hospital for Childrencollaborator
Study Sites (3)
Christiana Care Health Services
Newark, Delaware, 19713, United States
University of Delaware
Newark, Delaware, 19716, United States
Nemours Foundation
Wilmington, Delaware, 19803, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michele A. Lobo
- Organization
- University of Delaware
Study Officials
- PRINCIPAL INVESTIGATOR
Michele A Lobo, PT, PhD
University of Delaware
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Coders are blind to which study phase participants are in
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 10, 2013
Study Start
May 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
July 6, 2017
Results First Posted
July 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share