Motor intervention for infants at risk for cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a novel motor intervention called 'Let's Move' for infants at risk of developing cerebral palsy. The intervention combines clinic visits with home-based therapy delivered via video telehealth. The primary goals are to assess the feasibility and acceptability of the intervention, as well as to gather preliminary data on its effectiveness in improving motor skills. The study targets infants aged 3-8 months with specific MRI findings indicating a high risk for cerebral palsy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Karen Harpster, PhD, OTR/L — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Karen Harpster, PhD, OTR/L
• Email: karen.harpster@cchmc.org
• Phone: 513-803-3604

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.