Upper Extremity Dysfunction
Conditions
Keywords
Wilmington Robotic Exoskeleton, Reaching, Upper extremity function, Preterm Infants, Brain injury, Pediatrics, Early Intervention, Arthrogryposis
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.
Interventions
DEVICEMovement Enhancing Device
Naturalistic play activities using the hands while wearing the movement enhancing device.
Sponsors
Christiana Care Health Services
Alfred I. duPont Hospital for Children
University of Delaware
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Coders are blind to which study phase participants are in
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Movement Enhancing Device |
|---|---|
| Age, Continuous | 2.37 months STANDARD_DEVIATION 1.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: 7 months
Population: infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Movement Enhancing Device | Change in Time Contacting Objects | 40.75 percentage of time | Standard Deviation 30.06 |
Comparison: Repeated measures ANOVAp-value: <0.05ANOVA