Motor intervention for infants at risk for cerebral palsy
Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
This study is testing a new program called 'Let's Move' to see if it can help infants at risk for cerebral palsy improve their motor skills through a mix of clinic visits and home therapy using video calls.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 3 Months to 8 Months |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04886895 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants aged 3-8 months with specific MRI findings indicating a high risk for cerebral palsy and caregivers fluent in English.
Not a fit: Patients with medical conditions that restrict active participation, such as oxygen dependence, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance motor development in infants at risk for cerebral palsy, potentially improving their long-term outcomes.
How similar studies have performed: While this approach is innovative, similar interventions targeting motor skills in high-risk infants have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.