Condition category
Nervous System Diseases
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
02/11/2011
Prospective/Retrospective
Retrospectively 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 M Hadders-Algra

ORCID ID

Contact details

University Medical Center Groningen
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands
m.hadders-algra@med.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR361

Study information

Scientific title

Acronym

VIP

Study hypothesis

Intervention with the recently developed COPCA method improves developmental outcome at 6 and 18 months more than traditional types of early physiotherapeutical intervention.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cerebral parese (cerebral palsy)

Intervention

Intervention: COPCA = COPing with and CAring for infants with neurological dysfunction.
Control: traditional types of early physiotherapeutical intervention.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Neuromotor condition.

Secondary outcome measures

1. Pediatric Evaluation of Disability Inventory (PEDI)
2. KID-N and Bayley MDI
3. Parameters of postural control
4. NVOS
5. MPOC

Overall trial start date

01/03/2003

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Infants who have been referred to the Neonatal Intensive Care Unit (NICU) of the Beatrix Children's Hospital of the Unversity Medical Centre Groningen (UMCG) and who have definitely abnormal general movements at the corrected age of 3 months.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Presence of severe congenital anomaly
2. Inappropriate parental understanding of the Dutch language

Recruitment start date

01/03/2003

Recruitment end date

29/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Charity

Funder name

Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Foundation Fund Gavere (Stichting Fonds de Gavere) (The Netherlands)

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21719636

Publication citations

  1. Results

    Blauw-Hospers CH, Dirks T, Hulshof LJ, Bos AF, Hadders-Algra M, Pediatric physical therapy in infancy: from nightmare to dream? A two-arm randomized trial., Phys Ther, 2011, 91, 9, 1323-1338, doi: 10.2522/ptj.20100205.

Additional files

Editorial Notes