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| 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: | Allocation: Non-Randomized Control: Active Control 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 |
| 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 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 |
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| Contact: Jon S Skranes, MD, PhD | 99390285 ext 0047 | jon.skranes@ntnu.no |
| Contact: Ida E Vestrheim, PT,MSc | 38074389 ext 0047 | ida.vestrheim@sshf.no |
| Norway | |
| Sorlandet Hospital HF | Recruiting |
| Kristiansand, Norway, 4604 | |
| Contact: Kristian Sørensen, Psych 38074395 ext 0047 kristian.sorensen@sshf.no | |
| Sub-Investigator: Ida E Vestrheim, PT, cand san | |
| Principal Investigator: | Jon Skranes, MD, PhD | Sorlandet Hospital HF |
More Information
| Responsible Party: | Sorlandet Hospital HF ( Prof Jon Skranes, MD ) |
| ClinicalTrials.gov Identifier: | NCT00202761 History of Changes |
| Other Study ID Numbers: | SSHF70339 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 9, 2010 |
| Health Authority: | Norway: Directorate for Health and Social Affairs |
|
Cerebral palsy Functional training preschool children Gross Motor Functional Classification Level |
Gross motor functional Measure test Pediatric Evaluation of Disability Inventory Parental Stress Index |
|
Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases |