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

ISRCTN	ISRCTN52740878
DOI	https://doi.org/10.1186/ISRCTN52740878
Protocol serial number	60-61300-98-003
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 60-61300-98-003, thema II [kinderen])

Submission date: 09/09/2008
Registration date: 19/09/2008
Last edited: 11/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mijna Hadders-Algra
Scientific

PO Box 30001
Groningen
9713 GZ
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised single-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	L2M0-2
Study objectives	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(s)	Added 11/02/2009: Medical Ethics Committee of the University Medical Centre Groningen gave approval on the 24th October 2008 (ref: METc2008.176)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Score on the Infant Motor Profile (IMP) at baseline, after 3, 6 and 12 months after start of intervention.
Key secondary outcome measure(s)	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
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	9 Months
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

PO Box 30001

Groningen
9713 GZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes