NCT04886895 Motor Training for Infants With Cerebral Palsy
| NCT ID | NCT04886895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2022-01-07 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2022-01-07 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 effectiveness.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Karen Harpster, PhD, OTR/L
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT04886895 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 8 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04886895 currently recruiting?
Yes, NCT04886895 is actively recruiting participants. Contact the research team at karen.harpster@cchmc.org for enrollment information.
Where is the NCT04886895 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04886895 clinical trial?
NCT04886895 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Karen Harpster, PhD, OTR/L at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 35 participants.
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