Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-10 @ 2:41 PM
Study NCT ID:
NCT04280458
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2020-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of adaptative behaviour', 'timeFrame': 'At 12 months', 'description': 'Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.'}], 'secondaryOutcomes': [{'measure': 'Evolution of adaptative behaviour', 'timeFrame': 'At 6 months', 'description': 'Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.'}, {'measure': 'Evolution of development', 'timeFrame': 'At 12 months', 'description': 'Brunet-Lézine Scale will be used to evaluate the evolution of development.'}, {'measure': 'Pain evaluation', 'timeFrame': 'At 12 months', 'description': 'Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.'}, {'measure': 'Durability of acquired cognitive-motor abilities', 'timeFrame': 'at 18 months', 'description': 'Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.'}, {'measure': 'Durability of acquired cognitive-motor abilities', 'timeFrame': 'at 18 months', 'description': 'The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities.'}, {'measure': "Quality of family's life surveys", 'timeFrame': 'At baseline and 12 months', 'description': 'WHOQOL-Bref questionnaire will be used.'}, {'measure': 'Emotional distress measurement', 'timeFrame': 'At baseline and 12 months', 'description': "Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents."}, {'measure': 'Burden surveys', 'timeFrame': 'At baseline and 12 months', 'description': "Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents."}, {'measure': 'Clinical Global Impressions by caregivers', 'timeFrame': 'At baseline and 12 months', 'description': 'Clinical Global Impressions (CGI) Scale will be used by caregivers.'}, {'measure': "Quality of caregivers' life", 'timeFrame': 'At baseline and 12 months', 'description': 'The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children polyhandicap', 'rehabilitation', 'psychomotor', 'cognitive-motor', 'adaptative skill'], 'conditions': ['Polyhandicap']}, 'referencesModule': {'references': [{'pmid': '11743709', 'type': 'BACKGROUND', 'citation': 'Collignon P, Giusiano B. Validation of a pain evaluation scale for patients with severe cerebral palsy. Eur J Pain. 2001;5(4):433-42. doi: 10.1053/eujp.2001.0265.'}, {'pmid': '20526405', 'type': 'BACKGROUND', 'citation': 'Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.'}, {'pmid': '31392551', 'type': 'BACKGROUND', 'citation': 'Laor-Maayany R, Goldzweig G, Hasson-Ohayon I, Bar-Sela G, Engler-Gross A, Braun M. Compassion fatigue among oncologists: the role of grief, sense of failure, and exposure to suffering and death. Support Care Cancer. 2020 Apr;28(4):2025-2031. doi: 10.1007/s00520-019-05009-3. Epub 2019 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective of the study is to compare and evaluate the impact of intensive care of rehabilitation of psychomotor vs. the standard care on adaptive behaviour of children with polyhandicap at 12 months after randomization.', 'detailedDescription': "As secondary objectives, the study aims to:\n\n1. compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:\n\n * result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization;\n * result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization;\n * the pain evaluation at 12 months after randomization;\n * the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization);\n * the quality of life of the patients' family or relatives at 12 months after randomization;\n * the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization.\n2. evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.\n3. study the concordance between the Vineland scale and the Brunet-Lézine scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 4 and 13 years;\n* With polyhandicap defined by association of the 5 following criteria:\n\n * Causal brain injury occurred before the age of 3 years\n * Severe or deep mental deficiency as defined by IQ \\< 40, or no evaluable by the psychometric tests\n * Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders\n * Score of Gross Motor Function Classification System \\[Palisano 1997\\] is III, IV or V\n * Score of Functional Independence Measure \\< 50;\n* Hospitalization in a clinical setting participating to the study;\n* Beneficiary of a social protection;\n* Written consent signed by personnel holding parental authority or legal representative.\n\nExclusion Criteria:\n\n* Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases;\n* Planned to move in another clinical setting;\n* Foreseeable difficulty in the following up in the study.'}, 'identificationModule': {'nctId': 'NCT04280458', 'acronym': 'REEDUC-PLH', 'briefTitle': 'Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap', 'orgStudyIdInfo': {'id': 'APHP200866'}, 'secondaryIdInfos': [{'id': '2020-A00800-39', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'patients will receive intensive care of rehabilitation of psychomotor', 'interventionNames': ['Behavioral: Intentive rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'patients will receive standard care', 'interventionNames': ['Behavioral: Routine care']}], 'interventions': [{'name': 'Intentive rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Intervention included:\n\n* psychomotor 5 hours/week ±30 minutes\n* kinesitherapy 1.5 hour/week ±20 minutes\n\nduring 12 months.', 'armGroupLabels': ['Intervention group']}, {'name': 'Routine care', 'type': 'BEHAVIORAL', 'description': 'Intervention included:\n\n* kinesitherapy 0.5 hour/week ±10 minutes\n* psychomotor 30 min/week ±10 minutes during 12 months.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83407', 'city': 'Hyères', 'state': 'Var', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Christine ROUSSEAU, MD', 'role': 'CONTACT', 'email': 'marie-christine.rousseau@aphp.fr', 'phone': '+ 33 6 70 90 30 90'}], 'facility': 'Hôpital San Salvadour', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}], 'centralContacts': [{'name': 'Marie-Christine ROUSSEAU, MD', 'role': 'CONTACT', 'email': 'marie-Christine.rousseau@aphp.fr', 'phone': '+33 (4) 94 38 08 17'}], 'overallOfficials': [{'name': 'Marie-Christine ROUSSEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Polyhandicap adultes San Salvadour, APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}