Project:Intensive Habilitation (PIH) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

August 16, 2011

Start Date ^ICMJE

March 2004

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PEDI [ Time Frame: dec 2006 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00202761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PSI [ Time Frame: Dec 2006 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Project:Intensive Habilitation (PIH)

Official Title ^ICMJE

Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities

Brief Summary

The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals.

The study hypothesis are:

Intensive training will speed up the childs motor, cognitive and social development.

Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase II
Phase III

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Cerebral Palsy

Intervention ^ICMJE

Behavioral: PIH

Intensified training

Study Arms

Experimental: PIH

Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups.

Intervention: Behavioral: PIH

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

About three years of age Cerebral Palsy Multidisciplinary diagnosed -

Exclusion Criteria:

Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -

Gender

Both

Ages

up to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00202761

Other Study ID Numbers ^ICMJE

SSHF70339

Has Data Monitoring Committee

Yes

Responsible Party

Prof Jon Skranes, MD, Sorlandet Hospital HF

Study Sponsor ^ICMJE

Sorlandet Hospital HF

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jon Skranes, MD, PhD

Sorlandet Hospital HF

Information Provided By

Sorlandet Hospital HF

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP