Condition category
Nervous System Diseases
Date applied
25/01/2011
Date assigned
10/03/2011
Last edited
10/03/2011
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

Mrs Sigrid Ostensjo

ORCID ID

Contact details

Pilestredet 50
Oslo
N-0130
Norway
+47 (0)22 452 000
sigrid.ostensjo@hf.hio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of conductive education (CE) courses in combination with usual rehabilitation in preschool children with cerebral palsy (CP): a step wedge design randomised controlled trial

Acronym

Study hypothesis

Conductive education (CE) courses in combination with usual rehabilitation in preschool children with cerebral palsy (CP) improves gross motor function better than waiting list for CE in combination of usual rehabilitation

Ethics approval

Regional Ethics Committee in Norway approved in August 2010

Study design

Step wedge design randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

Three courses with CE during one year in combination with usual training and rehabilitation. One course of CE lasts for 3 weeks and contains CE-training 4 hours a day, five days a week.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Gross motor functions, measured at baseline and then after 4, 8 and 12 months

Secondary outcome measures

Measured at baseline and then after 4, 8 and 12 months:
1. Activities of daily living (ADL) quality of life (QoL) for both the child and parents
2. The parents experiences with the care

Overall trial start date

01/12/2010

Overall trial end date

15/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Preschool children with CP
2. Aged 3 - 6 years old, either sex

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

22

Participant exclusion criteria

Preschool children that already receive CE or attended CE courses for less than one year ago.

Recruitment start date

01/12/2010

Recruitment end date

15/03/2013

Locations

Countries of recruitment

Norway

Trial participating centre

Pilestredet 50
Oslo
N-0130
Norway

Sponsor information

Organisation

Oslo University College (Norway)

Sponsor details

Pilestredet 50
Oslo
N-0130
Norway
+47 (0)22 452 000
postmottak@hio.no

Sponsor type

University/education

Website

http://www.hio.no/Aktuelt/HiO-nytt

Funders

Funder type

University/education

Funder name

Oslo University College (Norway)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Norway

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