NCT00202761

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

13.8 years

First QC Date

September 12, 2005

Last Update Submit

March 11, 2022

Conditions

Cerebral Palsy

Keywords

Cerebral palsyFunctional trainingpreschool childrenGross Motor Functional Classification LevelGross motor functional Measure testPediatric Evaluation of Disability InventoryParental Stress Index

Outcome Measures

Primary Outcomes (1)

  • PEDI

    dec 2006

Secondary Outcomes (1)

  • PSI

    Dec 2006

Study Arms (1)

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

Interventions

PIHBEHAVIORAL

Intensified training

PIH

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • About three years of age Cerebral Palsy Multidisciplinary diagnosed -

You may not qualify if:

  • Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital HF

Kristiansand, 4604, Norway

Location

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jon Skranes, MD, PhD

    Sorlandet Hospital HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research administrator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2004

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

NO(1)