Condition category
Nervous System Diseases
Date applied
09/09/2008
Date assigned
19/09/2008
Last edited
11/02/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mijna Hadders-Algra

ORCID ID

Contact details

PO Box 30001
Groningen
9713 GZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

60-61300-98-003

Study information

Scientific title

Acronym

L2M0-2

Study hypothesis

One year of intervention with the new physiotherapeutic programme COPCA (see Interventions) results in a better motor developmental outcome than one year of intervention by means of traditional paediatric physiotherapy in infants at very high risk for cerebral palsy.

Ethics approval

Added 11/02/2009: Medical Ethics Committee of the University Medical Centre Groningen gave approval on the 24th October 2008 (ref: METc2008.176)

Study design

Randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cerebral palsy

Intervention

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 physiotherapists. The COPCA programme has motor and educational goals.

The motor goals:
a. To increase the infant's motor repertoire
b. To improve the ability to select a specific strategy fit for function in a specific daily life situation

Educational goals:
a. Promotion/restoration of intuitive parenting capacities, which in general are seriously affected in caregivers of infants with neurological disability
b. Coaching family members in such a way that they are able to cope well with life, including the developmental problems of the child

Schedule of the COPCA programme: 1 hour/session, 2 sessions per week for the first 6 months, and then 1 session every 2 weeks for the next 6 months (total duration of the programme: 1 year)

Description of the COPCA programme can be found at: http://www.ncbi.nlm.nih.gov/pubmed/17555816

The participants in the control group will receive traditional paediatric physiotherapy for 1 year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2009

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40 (2 groups of 20 children)

Participant 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

Recruitment start date

01/01/2009

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

PO Box 30001
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

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

Sponsor details

Laan van Nieuw Oost Indië 33
Den Haag
2509 AE
Netherlands
+31 (0)70 349 51 11
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 60-61300-98-003, thema II [kinderen])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes