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Movement Enhancing Device for Children

University of Delaware logo

University of Delaware

Status

Completed

Conditions

Upper Extremity Dysfunction

Treatments

Device: Movement Enhancing Device

Study type

Interventional

Funder types

Other

Identifiers

NCT01959581
1R21HD076092-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

1 month to 6 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Movement enhancing device
Other group
Description:
Guided play while wearing a movement assisting device
Treatment:
Device: Movement Enhancing Device

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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