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NCT Number: NCT04886895

Motor Training for Infants With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Let's Move Motor Intervention

Other

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 outcomes

  1. Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up

    Time frame: Baseline,16 weeks, 28 weeks

    Motor test

Secondary outcomes

  1. Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up

    Time frame: Baseline,16 weeks, 28 weeks

    Parent reported test for functional performance

  2. Change on Canadian Occupational Performance Measure before and after intervention and follow-up

    Time frame: Baseline,16 weeks, 28 weeks

    Caregivers perception of child's performance on functional goals

  3. Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up

    Time frame: Baseline,16 weeks, 28 weeks

    Neurological exam

  4. Preverbal visual assessment (PreViAs

    Time frame: Enrollment, 4 months later, 8 months later

    Screening tool for the development of visual maturation

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Harpster, PhD, OTR/L

CONTACT

[email protected]

513-803-3604

Nehal A Parikh, DO, MS

CONTACT

[email protected]

513-517-1044

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 14, 2021
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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