Project:Intensive Habilitation (PIH) - Full Text View

Sponsor:	Sorlandet Hospital HF
Information provided by:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00202761

Purpose

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

Condition	Intervention	Phase
Cerebral Palsy	Behavioral: PIH	Phase II Phase III

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	March 2004
Estimated Study Completion Date:	December 2011
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PIH: Experimental Intensified training	Behavioral: PIH Intensified training

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202761

Contacts

Contact: Jon S Skranes, MD, PhD	99390285 ext 0047	jon.skranes@ntnu.no
Contact: Ida E Vestrheim, PT,master of science	38074389 ext 0047	ida.vestrheim@sshf.no

Locations

Norway
Sorlandet Hospital HF	Recruiting
Kristiansand, Norway, 4604
Contact: Bjørn Lerdal, Psych 38074395 ext 0047
Sub-Investigator: Ida E Vestrheim, PT, cand san

Sponsors and Collaborators

Sorlandet Hospital HF

Investigators

Principal Investigator:

Jon Skranes, MD, PhD

Sorlandet Hospital HF

More Information

Additional Information:

Page describing the intensive habilitation program, and the childrens habilitation department at Sorlandet Hospital, HF , Norway This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sorlandet Hospital HF ( Prof Jon Skranes, MD )
Study ID Numbers:	SSHF70339
Study First Received:	September 12, 2005
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00202761 History of Changes
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by Sorlandet Hospital HF:

Cerebral palsy
Functional training
preschool children
Gross Motor Functional Classification Level

Gross motor functional Measure test
Pediatric Evaluation of Disability Inventory
Parental Stress Index

Additional relevant MeSH terms:

Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 09, 2010