Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 1:09 PM
Study NCT ID:
NCT04122820
Status:
UNKNOWN
Last Update Posted:
2019-10-18
First Post:
2019-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007802', 'term': 'Language'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D004410', 'term': 'Dyslexia'}, {'id': 'D019957', 'term': 'Motor Skills Disorders'}, {'id': 'D001072', 'term': 'Apraxias'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'An adjudication committee to determine the presence or absence of a specific learning disability will be set up, regardless of the presence of a central reference instability.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison of the presence of a specific learning disability, or a Developmental Coordination Disorder, in the case of the presence or absence of referential instability of central origin.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-10-05', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Calculation of results based on a Cut Off at -1.5 standard deviation, or -2 standard deviation, to determine the presence of a SLD or a DCD', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}], 'primaryOutcomes': [{'measure': 'Sensitivity of the HV-Labile to SLD or DCD', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Specificity of the HV-Labile to SLD or DCD', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}, {'measure': 'Positive and negative likelihood ratios', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}, {'measure': 'Prevalence of children with HV-Labile', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}, {'measure': 'Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}, {'measure': 'Positive predictive values', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}, {'measure': 'Negative predictive values', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Estimated and provided with its 95% confidence interval.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Specific Learning Disorder', 'Developmental Coordination Disorder', 'Specific Developmental Disorders of Speech and Language', 'Dyslexia, Developmental', 'Dyspraxia'], 'conditions': ['Specific Developmental Disorders of Speech and Language', 'Specific Learning Disorder', 'Dyslexia, Developmental', 'Developmental Coordination Disorder', 'Dyspraxia']}, 'referencesModule': {'references': [{'pmid': '26445526', 'type': 'RESULT', 'citation': 'Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'http://www.softal.fr/IMG/pdf/softa-poster-7_avril_14_-virlet-.pdf', 'label': 'The study undertaken with 100 all-view children shows a strong correlation between the presence of SDP-HV-labile and the presence of specific learning disorders. She encourages us not to neglect the proprioceptive approach in the study of the SLD.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate, in primary care, the sensitivity of Heterophory-Vertical-Labile (HV-Labile) in ambulatory screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). in children aged 8 to 12 years.', 'detailedDescription': 'General practitioners during a day of professional training on learning disabilities will be trained to perform the proprioceptive Maddox, to search for a HVLabile.\n\nEach trained practitioner will then test at least six children aged 8 to 12 years old in his or her practice, seen at random\n\n250 to 300 physicians will be trained as part of this research\n\nEXPERIMENTAL DESIGN\n\n* Cross-sectional study with prospective recruitment.\n* Search for a Vertical Labile Heterophory (HV-Labile).\n* Prescription of a standardized speech and language screening assessment for HV-Labile, and in the same number of children without HV-Labile by secondary coupling.\n* Delivery of symptomatic questionnaire.\n* In case of learning disabilities, the attending physician should look for a possible etiology.\n* Adapted speech therapy care for more than six months.\n* Speech and language therapy check-up at more than six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe population studied is composed of children:\n\n* from 8 to 12 years old\n* seen for any reason for consultation in general practice\n* Schooled in an ordinary environment since the Preparatory Course in France\n* Francophone parents\n* One of whose parents has signed the consent\n* Consent of the child\n* Social Insured\n\nExclusion Criteria:\n\nThe background and living conditions that may promote secondary learning disabilities, for example:\n\n* Child with a known intellectual disability (Wisc)\n* Child in IME (Institut Médico Educatif)\n* Child followed in SESSAD (Specialised education service at home)\n* Child not knowing how to answer the questions asked\n* Child with a known etiology causing learning disabilities (epilepsy, autism spectrum disorder, hearing impairment, visual impairment (deafness, blindness, low vision))\n* Child on treatment (antiepileptic, neuroleptic, antidepressant, anxiolytic)\n* Child under the care of a psychiatrist,\n* Child followed by the CMP (Centre médico-psychologique)\n* Child living in an institution,\n* Adopted child\n* A child whose mother has experienced known depression during the child's early childhood (0-18 months) because it causes attachment disorders, which can impact the child's development, including learning\n* Child of a family that has lived through more than two family recompositions\n* Child known to be a victim of abuse.\n* Out of school child.\n\nTo determine the presence of an HV-Labile\n\n* Child with a known visual correction greater than + or- 2 diopters\n* Known amblyopic child\n* Known strabic child\n* Child with no known binocular vision."}, 'identificationModule': {'nctId': 'NCT04122820', 'acronym': 'TDys', 'briefTitle': 'Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).', 'organization': {'class': 'OTHER', 'fullName': 'CNGE IRMG Association'}, 'officialTitle': 'Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).', 'orgStudyIdInfo': {'id': 'CNGEIRMG 0310'}, 'secondaryIdInfos': [{'id': '2019-A00416-51', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Presence of HV-Labile', 'description': 'Presence of vertical heterophoria labile with proprioceptive Maddox', 'interventionNames': ['Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder']}, {'type': 'OTHER', 'label': 'Absence of HV-Labile', 'description': 'Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox', 'interventionNames': ['Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder']}], 'interventions': [{'name': 'Diagnostic of specific learning disabilities or of Developmental Coordination Disorder', 'type': 'DIAGNOSTIC_TEST', 'description': 'Speech therapy assessment, or occupational therapy. In case of pathological disorder, search for a sensory disorder, and therapeutic management. If the pathological disorder persists for more than six months, elimination of a secondary etiology.', 'armGroupLabels': ['Absence of HV-Labile', 'Presence of HV-Labile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'state': 'Alsace', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Luc Virlet', 'role': 'CONTACT', 'email': 'virlet.luc@laposte.net', 'phone': '+33678296310'}], 'facility': 'Office-based general practioner', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Luc Virlet', 'role': 'CONTACT', 'email': 'virlet.luc@laposte.net', 'phone': '+33678296310'}, {'name': 'Joel Cogneau', 'role': 'CONTACT', 'email': 'j.cogneau@irmg.fr', 'phone': '+33674787920'}], 'overallOfficials': [{'name': 'Luc Virlet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SCalab CNRS 9193, Lille University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CNGE IRMG Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scalab CNRS 9193', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luc Virlet', 'investigatorAffiliation': 'Scalab CNRS 9193'}}}}