Clinical trial NCT04886895: Motor Training for Infants With Cerebral Palsy
Official title: Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor skills
occupational therapy
physical therapy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single cohort
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up
timeFrame: Baseline,16 weeks, 28 weeks
Secondary outcomes:
measure: Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up
timeFrame: Baseline,16 weeks, 28 weeks
measure: Change on Canadian Occupational Performance Measure before and after intervention and follow-up
timeFrame: Baseline,16 weeks, 28 weeks
measure: Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up
timeFrame: Baseline,16 weeks, 28 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Karen Harpster, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: