Movement Enhancing Device for Children

• Sponsor: University of Delaware (Other)
• Overall Status: Completed
• CT.gov ID: NCT01959581
• Collaborator: Christiana Care Health Services (Other), Alfred I. duPont Hospital for Children (Other)
• Enrollment: 30
• Locations: 3
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Extremity Dysfunction	Device: Movement Enhancing Device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Coders are blind to which study phase participants are in
• Primary Purpose: Treatment
• Official Title: An Innovative Device for Intervention in Infants With Nervous System Injury
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: WREX (Wilmington Robotic Exoskeleton)

Outcome Measures

Primary Outcome Measures

1. Change in Time Contacting Objects [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 6 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health Services	Newark	Delaware	United States	19713
2	University of Delaware	Newark	Delaware	United States	19716
3	Nemours Foundation	Wilmington	Delaware	United States	19803

Sponsors and Collaborators

• University of Delaware
• Christiana Care Health Services
• Alfred I. duPont Hospital for Children

Investigators

• Principal Investigator: Michele A Lobo, PT, PhD, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Delaware
• ClinicalTrials.gov Identifier: NCT01959581
• Other Study ID Numbers: 1R21HD076092-01A1
• First Posted: Oct 10, 2013
• Last Update Posted: Jul 6, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Delaware: Wilmington Robotic Exoskeleton; Reaching; Upper extremity function; Preterm Infants; Brain injury; Pediatrics; Early Intervention; Arthrogryposis

Study Results

Participant Flow

Arm/Group Title	Movement Enhancing Device
Arm/Group Description	Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Period Title: Overall Study
STARTED	30
COMPLETED	25
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Movement Enhancing Device
Arm/Group Description	Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Overall Participants	25
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	2.37 (1.26)
Sex: Female, Male (Count of Participants)
Female	16 64%
Male	9 36%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4%
Not Hispanic or Latino	24 96%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 12%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 24%
White	16 64%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Change in Time Contacting Objects
Description	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.
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita

Arm/Group Title	Movement Enhancing Device
Arm/Group Description	Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Measure Participants	20
Mean (Standard Deviation) [percentage of time]	40.75 (30.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Movement Enhancing Device
	Comments	Repeated measures ANOVA
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Movement Enhancing Device
Arm/Group Description	Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
All Cause Mortality
	Movement Enhancing Device
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Movement Enhancing Device
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Movement Enhancing Device
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.