Motor Training for Infants With Cerebral Palsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Let's Move


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Let's Move Intervention<br>Let's Move intervention will be administered and videotaped for 20 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, there will be two clinic-based sessions followed by 2 telehealth-based sessions | Other: Let's Move<br>* Motor intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up | Motor test | Baseline,16 weeks, 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up | Parent reported test for functional performance | Baseline,16 weeks, 28 weeks | 
| Change on Canadian Occupational Performance Measure before and after intervention and follow-up | Caregivers perception of child's performance on functional goals | Baseline,16 weeks, 28 weeks | 
| Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up | Neurological exam | Baseline,16 weeks, 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor skills, occupational therapy, physical therapy