Motor Training for Infants With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Let's Move Motor Intervention.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 3 months — 8 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
Overview
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
- Other Let'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
Primary outcome measures
- Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up [Time frame: Baseline,16 weeks, 28 weeks]
Secondary outcome measures (4)
- Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up [Time frame: Baseline,16 weeks, 28 weeks]
- Change on Canadian Occupational Performance Measure before and after intervention and follow-up [Time frame: Baseline,16 weeks, 28 weeks]
- Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up [Time frame: Baseline,16 weeks, 28 weeks]
- Preverbal visual assessment (PreViAs [Time frame: Enrollment, 4 months later, 8 months later]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT04886895 · 2021-0305