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NCT Number: NCT05576948

Natural History of Cerebral Palsy Prospective Study

The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.

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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–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Karen L Harpster, PhD, OTR/L

CONTACT

[email protected]

513-803-3604

About this study

This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed at regular intervals up to 24 months of age, across a variety of childhood development to provide the first comprehensive developmental trajectories of this group. In doing so, it will contribute to the existing knowledge of CP development to assist clinicians and therapists with accurate information on prognosis and provide targeted interventions early and at the 'just-right' challenge. Where indicated, individual participants' results from this study will be used to inform their therapy. This study is intended to form part of a larger multi-site international study.

Who can participate

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

Inclusion criteria

  • Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
  • Infants at high risk of CP as defined by any two (any combination) of the following:
  • Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
  • Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
  • Hammersmith Infant Neurological Exam (HINE) scores <57 @ 3months or <60 @ 6months or <63 @9 months

Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above:

i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry

Exclusion criteria

  • Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
  • Infants with other disability diagnoses e.g. Down Syndrome

Treatment and study plan

Primary outcomes

  1. Change in Motor skills

    Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

    Peabody: Gross and Fine motor skills

  2. Change in Speech and Language skills

    Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

    Bayley Scales of Infant and Toddler Development

  3. Change in Cognitive skills

    Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

    Bayley Scales of Infant and Toddler Development

  4. Change in Neurologic assessment

    Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

    Hammersmith Infant Neurological Examination

  5. Change in Musculoskeletal assessment

    Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

    Modified Tardieu Scale

  6. Change in Musculoskeletal assessment

    Time frame: 9 months, 12 months, 18 months, 24 months (corrected age)

    Australian Spasticity Assessment Scale

  7. Change in Musculoskeletal assessment

    Time frame: 18 months, 24 months corrected age

    Hip X-ray

  8. Change in Vision

    Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

    Previas

  9. Vision

    Time frame: 3 months corrected age

    Ricci

  10. Change in Sleep

    Time frame: 9 months, 12 months, 18 months, 24 months (corrected age)

    Sleep disturbances Scale for Children

  11. Change in Feeding skills

    Time frame: 12 months, 18 months, 24 months (corrected age)

    Dysphagia Disorder Survey

  12. Change in Self Care

    Time frame: 6 months, 12 months, 18 months, 24 months (corrected age)

    Pediatric Evaluation of Disability Inventory Computerized Assessment Test

  13. Change in Adaptive Behavior

    Time frame: 12 months, 18 months, 24 months (corrected age)

    Infant Toddler Social Emotional Assessment

  14. Change in Parent Well Being

    Time frame: 12 months, 18 months, 24 months (corrected age)

    Depression, Anxiety and Stress Scale

Study contacts

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

Karen L Harpster, PhD

CONTACT

[email protected]

513-803-3604

Kelly Greve, PhD

CONTACT

[email protected]

(513) 636-3605

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Cerebral Palsy Alliance

Registry information

Official study title

Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 13, 2022
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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