Cerebral Palsy
Conditions
Keywords
motor skills, occupational therapy, physical therapy
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.
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) therapy model.
Interventions
OTHERLet's Move Motor Intervention
Let's Move intervention will be administered and videotaped with infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single cohort
Eligibility
Sex/Gender
ALL
Age
3 Months to 8 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up | Baseline,16 weeks, 28 weeks | Motor test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up | Baseline,16 weeks, 28 weeks | Parent reported test for functional performance |
| Change on Canadian Occupational Performance Measure before and after intervention and follow-up | Baseline,16 weeks, 28 weeks | Caregivers perception of child's performance on functional goals |
| Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up | Baseline,16 weeks, 28 weeks | Neurological exam |
| Preverbal visual assessment (PreViAs | Enrollment, 4 months later, 8 months later | Screening tool for the development of visual maturation |
Countries
United States
Contacts
Primary ContactKaren Harpster, PhD, OTR/L
Backup ContactNehal A Parikh, DO, MS
Outcome results
None listed