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Learn to Move 0-2 years: Early intervention in children with cerebral palsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52740878
Enrollment
40
Registered
2008-09-19
Start date
2009-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral palsy Nervous System Diseases Cerebral palsy

Interventions

COPCA = "COPing with and CAring for infants with neurological dysfunction" programme: The COPCA programme is a home based programme, and will be delivered by specially trained paediatric physiotherap

Sponsors

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Score on the Infant Motor Profile (IMP) at baseline, after 3, 6 and 12 months after start of intervention.

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026