earn to Move 0-2 years: Early intervention in children with cerebral palsy
- Conditions
- Cerebral palsyNervous System Diseases
- Registration Number
- ISRCTN52740878
- Lead Sponsor
- The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Score on the Infant Motor Profile (IMP) at baseline, after 3, 6 and 12 months after start of intervention.
- Secondary Outcome Measures
Name Time Method 1. Neurological condition, assessed at 3, 6 and 12 months<br>2. Alberta Infant Motor Scale (AIMS), assessed at 3, 6 and 12 months<br>3. Gross Motor Function Measure (GMFM), assessed at 3, 6 and 12 months<br>4. Bayley Scales of Infant Development (BSID), assessed at 3, 6 and 12 months<br>5. Vineland Adaptive Behavior Scales (VABS), assessed at 6 and 12 months<br>6. Pediatric Evaluation of Disability Inventory (PEDI), assessed at 12 months <br>7. Nijmeegse Ouderlijke Stress Index (NOSI-K), assessed at 12 months <br>8. Utrecht Coping List (UCL), assessed at 12 months <br>9. Family Empowerment Scale (FES), assessed at 6 and 12 months<br>10. Measure of Processes Of Care (MPOC), assessed at 12 months