Project:Intensive Habilitation (PIH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sissel Ledang, Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00202761
First received: September 12, 2005
Last updated: May 27, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 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 2014
Estimated Primary Completion Date: December 2014 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Sissel Ledang, Research administrator, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202761     History of Changes
Other Study ID Numbers: SSHF70339
Study First Received: September 12, 2005
Last Updated: May 27, 2014
Health Authority: Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on September 18, 2014