Learn to Move 0-2 years: Early intervention in children with cerebral palsy
| ISRCTN | ISRCTN52740878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52740878 |
| Secondary identifying numbers | 60-61300-98-003 |
- 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
Scientific
PO Box 30001
Groningen
9713 GZ
Netherlands
Study information
| Study design | Randomised single-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 9 Months |
| Sex | Both |
| Target number of participants | 40 (2 groups of 20 children) |
| 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
9713 GZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 33
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 349 51 11 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 60-61300-98-003, thema II [kinderen])
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
