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Natural History of Cerebral Palsy Prospective Study 100
Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study
- 2022-0189
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
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. | 不适用 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in Motor skills | Peabody: Gross and Fine motor skills | 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Speech and Language skills | Bayley Scales of Infant and Toddler Development | 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Cognitive skills | Bayley Scales of Infant and Toddler Development | 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Neurologic assessment | Hammersmith Infant Neurological Examination | 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Musculoskeletal assessment | Modified Tardieu Scale | 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Musculoskeletal assessment | Australian Spasticity Assessment Scale | 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Musculoskeletal assessment | Hip X-ray | 18 months, 24 months corrected age |
Change in Vision | Previas | 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) |
Vision | Ricci | 3 months corrected age |
Change in Sleep | Sleep disturbances Scale for Children | 9 months, 12 months, 18 months, 24 months (corrected age) |
Change in Feeding skills | Dysphagia Disorder Survey | 12 months, 18 months, 24 months (corrected age) |
Change in Self Care | Pediatric Evaluation of Disability Inventory Computerized Assessment Test | 6 months, 12 months, 18 months, 24 months (corrected age) |
Change in Adaptive Behavior | Infant Toddler Social Emotional Assessment | 12 months, 18 months, 24 months (corrected age) |
Change in Parent Well Being | Depression, Anxiety and Stress Scale | 12 months, 18 months, 24 months (corrected age) |
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
- Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
- Infants with other disability diagnoses e.g. Down Syndrome
Children's Hospital Medical Center, CincinnatiCerebral Palsy AllianceOhio