Status:
RECRUITING
Motor Training for Infants With Cerebral Palsy
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary ef...
Detailed Description
The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) ther...
Eligibility Criteria
Inclusion
- Age at enrollment: between 3-8 months corrected age
- Caregivers fluent in English
- Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
- High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
- "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
- A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)
Exclusion
- Medical conditions that restrict active participation such as oxygen dependence
- Infants with significant visual deficits defined by the inability to track an object horizontally
- Living in a remote location prohibiting drives to the hospital every other week.
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04886895
Start Date
January 7 2022
End Date
January 1 2028
Last Update
September 25 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229