Cerebral palsy Nervous System Diseases Cerebral palsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both males and females, corrected age at enrolment 3 to 9 months 2. At very high risk for cerebral palsy (CP), based on the presence of one of the following: a. Cystic periventricular leukomalacia (PVL), diagnosed on serial ultrasound assessment of the brain b. Uni- or bilateral parenchymal lesion of the brain c. Term/near term asphyxia resulting in Sarnat 2 or 3 with brain lesions on magnetic resonance imaging (MRI) and/or neurological dysfunction during infancy suggesting the development of CP d. Neurological dysfunction suggestive of development of CP
Exclusion criteria
Exclusion criteria: 1. Caregivers have insufficient understanding of the Dutch language 2. Infants who have an additional severe congenital disorder, such as a serious congenital heart disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on the Infant Motor Profile (IMP) at baseline, after 3, 6 and 12 months after start of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurological condition, assessed at 3, 6 and 12 months 2. Alberta Infant Motor Scale (AIMS), assessed at 3, 6 and 12 months 3. Gross Motor Function Measure (GMFM), assessed at 3, 6 and 12 months 4. Bayley Scales of Infant Development (BSID), assessed at 3, 6 and 12 months 5. Vineland Adaptive Behavior Scales (VABS), assessed at 6 and 12 months 6. Pediatric Evaluation of Disability Inventory (PEDI), assessed at 12 months 7. Nijmeegse Ouderlijke Stress Index (NOSI-K), assessed at 12 months 8. Utrecht Coping List (UCL), assessed at 12 months 9. Family Empowerment Scale (FES), assessed at 6 and 12 months 10. Measure of Processes Of Care (MPOC), assessed at 12 months | — |
Countries
Netherlands