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| Name | Class |
|---|---|
| Christiana Care Health Services | OTHER |
| Alfred I. duPont Hospital for Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Movement enhancing device | Other | Guided play while wearing a movement assisting device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Movement Enhancing Device | Device | Naturalistic play activities using the hands while wearing the movement enhancing device. |
|
| 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 |
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Inclusion Criteria:
• Infants will be invited to participate if they are between 1 month and 6 years and:
Exclusion Criteria:
• blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.
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| Name | Affiliation | Role |
|---|---|---|
| Michele A Lobo, PT, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19713 | United States | ||
| University of Delaware |
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| ID | Title | Description |
|---|---|---|
| FG000 | Movement Enhancing Device | Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Movement Enhancing Device | Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita | Posted | Mean | Standard Deviation | percentage of time | 7 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Movement Enhancing Device | Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele A. Lobo | University of Delaware | 302-831-8526 | malobo@udel.edu |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001176 | Arthrogryposis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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Coders are blind to which study phase participants are in
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| Newark |
| Delaware |
| 19716 |
| United States |
| Nemours Foundation | Wilmington | Delaware | 19803 | United States |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |