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Project:Intensive Habilitation (PIH)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202761
First Posted: September 20, 2005
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sissel Ledang, Sorlandet Hospital HF
  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 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities

Resource links provided by NLM:


Further study details as provided by Sissel Ledang, Sorlandet Hospital HF:

Primary Outcome Measures:
  • PEDI [ Time Frame: dec 2006 ]

Secondary Outcome Measures:
  • PSI [ Time Frame: Dec 2006 ]

Estimated Enrollment: 20
Study Start Date: March 2004
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PIH
Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups.
Behavioral: PIH
Intensified training

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202761


Locations
Norway
Sorlandet Hospital HF
Kristiansand, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Jon Skranes, MD, PhD Sorlandet Hospital HF
  More Information

Additional Information:
Responsible Party: Sissel Ledang, Research administrator, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202761     History of Changes
Other Study ID Numbers: SSHF70339
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Sissel Ledang, 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
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases