Natural History of Cerebral Palsy Prospective Study
Study Details
Study Description
Brief Summary
The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Children with or at high risk of CP Infants with a diagnosis of CP OR at high risk of CP as per the international Clinical Practice Guideline for early diagnosis of CP. In order to develop prognostic curves for motor function a minimum of 3 data points are required per participant. For this reason infants will be included if they are 12 months or younger (corrected age) at the time of enrolment. |
Outcome Measures
Primary Outcome Measures
- Change in Motor skills [3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
Peabody: Gross and Fine motor skills
- Change in Speech and Language skills [6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
Bayley Scales of Infant and Toddler Development
- Change in Cognitive skills [6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
Bayley Scales of Infant and Toddler Development
- Change in Neurologic assessment [3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
Hammersmith Infant Neurological Examination
- Change in Musculoskeletal assessment [3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
Modified Tardieu Scale
- Change in Musculoskeletal assessment [9 months, 12 months, 18 months, 24 months (corrected age)]
Australian Spasticity Assessment Scale
- Change in Musculoskeletal assessment [18 months, 24 months corrected age]
Hip X-ray
- Change in Vision [6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
Previas
- Vision [3 months corrected age]
Ricci
- Change in Sleep [9 months, 12 months, 18 months, 24 months (corrected age)]
Sleep disturbances Scale for Children
- Change in Feeding skills [12 months, 18 months, 24 months (corrected age)]
Dysphagia Disorder Survey
- Change in Self Care [6 months, 12 months, 18 months, 24 months (corrected age)]
Pediatric Evaluation of Disability Inventory Computerized Assessment Test
- Change in Adaptive Behavior [12 months, 18 months, 24 months (corrected age)]
Infant Toddler Social Emotional Assessment
- Change in Parent Well Being [12 months, 18 months, 24 months (corrected age)]
Depression, Anxiety and Stress Scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
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Infants at high risk of CP as defined by any two (any combination) of the following:
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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.
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Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
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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:
- Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry
Exclusion Criteria:
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Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
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Infants with other disability diagnoses e.g. Down Syndrome
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
- Cerebral Palsy Alliance
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-0189