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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | November 11, 2008 | ||||||||
| 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 |
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| Detailed Description | |||||||||
| Study Phase | Phase II, Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Other, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study | ||||||||
| Condition ICMJE | Cerebral Palsy | ||||||||
| Intervention ICMJE | Behavioral: PIH
Intensified training |
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| Study Arms / Comparison Groups | PIH: Experimental
Intensified training
Intervention: Behavioral: PIH |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| 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 - |
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| Gender | Both | ||||||||
| Ages | up to 5 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00202761 | ||||||||
| Responsible Party | Prof Jon Skranes, MD, Sorlandet Hospital HF | ||||||||
| Study ID Numbers ICMJE | SSHF70339 | ||||||||
| Study Sponsor ICMJE | Sorlandet Hospital HF | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Sorlandet Hospital HF | ||||||||
| Verification Date | November 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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