Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-01 @ 1:57 AM
Study NCT ID:
NCT00202761
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project:Intensive Habilitation (PIH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PEDI', 'timeFrame': 'dec 2006'}], 'secondaryOutcomes': [{'measure': 'PSI', 'timeFrame': 'Dec 2006'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'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'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.habu.no', 'label': 'Page describing the intensive habilitation program, and the childrens habilitation department at Sorlandet Hospital, HF , Norway'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals.\n\nThe study hypothesis are:\n\nIntensive training will speed up the childs motor, cognitive and social development.\n\nIntensive 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAbout three years of age Cerebral Palsy Multidisciplinary diagnosed -\n\nExclusion Criteria:\n\nNot have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -'}, 'identificationModule': {'nctId': 'NCT00202761', 'briefTitle': 'Project:Intensive Habilitation (PIH)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities', 'orgStudyIdInfo': {'id': 'SSHF70339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIH', 'description': 'Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups.', 'interventionNames': ['Behavioral: PIH']}], 'interventions': [{'name': 'PIH', 'type': 'BEHAVIORAL', 'description': 'Intensified training', 'armGroupLabels': ['PIH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4604', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sorlandet Hospital HF', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Jon Skranes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sorlandet Hospital HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research administrator', 'investigatorFullName': 'Sissel Ledang', 'investigatorAffiliation': 'Sorlandet Hospital HF'}}}}