Project:Intensive Habilitation (PIH)
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
PIH
Sponsored by
About this trial
This is an interventional other trial for Cerebral Palsy focused on measuring Cerebral palsy, Functional training, preschool children, Gross Motor Functional Classification Level, Gross motor functional Measure test, Pediatric Evaluation of Disability Inventory, Parental Stress Index
Eligibility 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 -
Sites / Locations
- Sorlandet Hospital HF
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PIH
Arm Description
Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups.
Outcomes
Primary Outcome Measures
PEDI
Secondary Outcome Measures
PSI
Full Information
NCT ID
NCT00202761
First Posted
September 12, 2005
Last Updated
March 11, 2022
Sponsor
Sorlandet Hospital HF
1. Study Identification
Unique Protocol Identification Number
NCT00202761
Brief Title
Project:Intensive Habilitation (PIH)
Official Title
Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Functional training, preschool children, Gross Motor Functional Classification Level, Gross motor functional Measure test, Pediatric Evaluation of Disability Inventory, Parental Stress Index
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PIH
Arm Type
Experimental
Arm Description
Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups.
Intervention Type
Behavioral
Intervention Name(s)
PIH
Intervention Description
Intensified training
Primary Outcome Measure Information:
Title
PEDI
Time Frame
dec 2006
Secondary Outcome Measure Information:
Title
PSI
Time Frame
Dec 2006
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Skranes, MD, PhD
Organizational Affiliation
Sorlandet Hospital HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital HF
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
12. IPD Sharing Statement
Links:
URL
http://www.habu.no
Description
Page describing the intensive habilitation program, and the childrens habilitation department at Sorlandet Hospital, HF , Norway
Learn more about this trial
Project:Intensive Habilitation (PIH)
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