Movement Enhancing Device for Children

Study Overview
=================
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.

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.

Official Title
-----------------
An Innovative Device for Intervention in Infants With Nervous System Injury

Conditions
-----------------
Upper Extremity Dysfunction

Intervention / Treatment
-----------------
* Device: Movement Enhancing Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Movement enhancing device<br>Guided play while wearing a movement assisting device | Device: Movement Enhancing Device<br>* Naturalistic play activities using the hands while wearing the movement enhancing device.<br>* 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wilmington Robotic Exoskeleton, Reaching, Upper extremity function, Preterm Infants, Brain injury, Pediatrics, Early Intervention, Arthrogryposis