Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 10:13 AM
Study NCT ID:
NCT05236803
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement performance of fine motor skills (graphics, pointing task)', 'timeFrame': 'At 3 month', 'description': 'Jointly and in an automated and standardized manner, measure performance in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).'}, {'measure': 'Measurement performance of general motor skills with biomechanical analysis', 'timeFrame': 'At 3 month', 'description': 'Jointly and in an automated and standardized manner, measure motor patterns in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).'}, {'measure': 'Measurement of oculomotricity with eye-tracking system (visual orientation and control)', 'timeFrame': 'At 3 month', 'description': 'Jointly and in an automated and standardized manner, motor patterns in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).'}], 'secondaryOutcomes': [{'measure': 'Motor performance : success, error rate (%)', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months'}, {'measure': 'Motor performance : task duration (ms), reaction time (ms) and latency (ms)', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months'}, {'measure': 'IQ as assessed using WISC IV', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months'}, {'measure': 'Score of socio-communicative skills as assessed using Social Responsiveness Scale', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months', 'description': 'Social Responsiveness Scale :\n\nMin = 30, Max=90 Higher scores mean a worse outcome'}, {'measure': 'ADHD as assessed using Conners-3', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months'}, {'measure': 'Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months', 'description': 'Developmental Coordination Disorder Questionnaire :\n\nMin = 15, Max = 75 Higher scores mean a better outcome'}, {'measure': 'ASD Clinical Assessment as assessed using Childhood Autism Rating Scale', 'timeFrame': 'At visit 1 and visit 2, an average of 3 months', 'description': 'Childhood Autism Rating Scale :\n\nMin = 0, Max = 100 Higher scores mean a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autisme Spectrum Disorders', 'Motricity', 'Cognitive disorders', 'Behaviour', 'motor skill differences'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '30618953', 'type': 'RESULT', 'citation': 'Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.'}, {'pmid': '28748333', 'type': 'RESULT', 'citation': 'Cazalets JR, Bestaven E, Doat E, Baudier MP, Gallot C, Amestoy A, Bouvard M, Guillaud E, Guillain I, Grech E, Van-Gils J, Fergelot P, Fraisse S, Taupiac E, Arveiler B, Lacombe D. Evaluation of Motor Skills in Children with Rubinstein-Taybi Syndrome. J Autism Dev Disord. 2017 Nov;47(11):3321-3332. doi: 10.1007/s10803-017-3259-1.'}, {'pmid': '26594140', 'type': 'RESULT', 'citation': "D'Mello AM, Stoodley CJ. Cerebro-cerebellar circuits in autism spectrum disorder. Front Neurosci. 2015 Nov 5;9:408. doi: 10.3389/fnins.2015.00408. eCollection 2015."}, {'pmid': '32408186', 'type': 'RESULT', 'citation': 'Eggleston JD, Harry JR, Cereceres PA, Olivas AN, Chavez EA, Boyle JB, Dufek JS. Lesser magnitudes of lower extremity variability during terminal swing characterizes walking patterns in children with autism. Clin Biomech (Bristol). 2020 Jun;76:105031. doi: 10.1016/j.clinbiomech.2020.105031. Epub 2020 May 7.'}, {'pmid': '24349379', 'type': 'RESULT', 'citation': 'Hak L, Houdijk H, Beek PJ, van Dieen JH. Steps to take to enhance gait stability: the effect of stride frequency, stride length, and walking speed on local dynamic stability and margins of stability. PLoS One. 2013 Dec 13;8(12):e82842. doi: 10.1371/journal.pone.0082842. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.', 'detailedDescription': 'The main objective is to measure jointly and in an automated and standardized manner the performance and motor patterns within the framework of tasks measuring the performance and patterns of general motor skills (postures, walking, coordination overall), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).\n\nThe secondary objective is to investigate the relationships between motor difficulties and cognitive and social disorders found in children with ASD.\n\n* Compare the motor performance data in the 3 major motor domains with each other (overall, fine and oculomotor);\n* Evaluate intergroup differences based on clinical characteristics (ADOS-2, ADI-R, CARS 2 scores), age, IQ, socio-communication profile score (SRS-2) and presence comorbidities (TADH, TDC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\nAll participants :\n\n* Be between 6 and 11 years old\n* Mastery of the French language\n* Be affiliated with a Social Security scheme or benefit from affiliation by a third person\n* Both parents (or the holder of legal authority) have read, understood and signed the study consent\n* Be affiliated with social security\n\nParticipants with ASD should also verify the following inclusion criteria:\n\n* Being diagnosed with ASD (DSM-V)\n\nExclusion Criteria :\n\nAll participants :\n\n* Refusal to participate in the research on the part of the participant and / or holders of parental authority.\n* Be a person benefiting from enhanced protection, namely : persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment.\n* Have uncorrected visual or hearing problems\n* To have concomitant psychotropic drug treatments not stabilized, initiated in the last 2 months: antipsychotics, mood stabilizers, anti-epileptics, psychostimulants, antidepressants.\n* Have a motor handicap of the upper or lower limbs, fitted or not.\n* Have diagnosed neurological or psychiatric disorders, present a general or metabolic pathology having a known impact on the child's motor skills (eg: Epilepsy, Tics and Gilles de la Tourette Syndrome, Intellectual Deficiency, Neuromuscular Syndrome, Metabolic Neurological Syndrome , neoplasms)\n* Suspicion of low intellectual efficiency if at least one of the two subtests (Similarities or Matrices) of WISC V (retrieved from the medical file if the TSA participant) presents a result (standard score) strictly lower than 7.\n\nParticipants without ASD :\n\n* Participant with ADHD (Attention Deficit Disorder with or without Hyperactivity) or CDD (Developmental Coordination Disorder)"}, 'identificationModule': {'nctId': 'NCT05236803', 'acronym': 'MOTRICITE TSA', 'briefTitle': 'Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centre Hospitalier Charles Perrens, Bordeaux'}, 'officialTitle': 'Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol', 'orgStudyIdInfo': {'id': '2021-A02426-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Epidemiology', 'description': "Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.", 'interventionNames': ['Behavioral: Testing of general motor skills, fine motor skills and occulomotricity', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Testing of general motor skills, fine motor skills and occulomotricity', 'type': 'BEHAVIORAL', 'description': "Recording of participant's performance during eye, fine motor and gross motor tests; Children's gross motor skills will be assessed through a biomechanical analysis.\n\nEye movements will be recorded using the eye-tracking system (Tobii Pro TX300). The technique used is the corneal reflection technique.", 'armGroupLabels': ['Epidemiology']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Passing self and hetero questionnaires.', 'armGroupLabels': ['Epidemiology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anouck AMESTOY, MD', 'role': 'CONTACT', 'email': 'aamestoy@ch-perrens.fr', 'phone': '05 56 56 67 19'}], 'facility': 'Centre Hospitalier Charles Perrens', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '17019', 'city': 'La Rochelle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline ALLIX-BEGUEC, Ph.D.', 'role': 'CONTACT', 'email': 'caroline.allix-beguec@ght-atlantique17.fr', 'phone': '05 16 49 42 46', 'phoneExt': '54 246'}, {'name': 'Helene COTTENCEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier La Rochelle Re Aunis', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascale DURET-BLANC', 'role': 'CONTACT', 'email': 'pascale.duret-blanc@chu-limoges.fr', 'phone': '05.55.05.89.87'}, {'name': 'Eric LEMONNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de LIMOGES', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '86021', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie VALIER-BRASIER', 'role': 'CONTACT', 'email': 'emilie.valier-brasier@ch-poitiers.fr', 'phone': '05.49.44.57.59'}, {'name': 'Jean XAVIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Henri Laborit', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Anouck AMESTOY, MD', 'role': 'CONTACT', 'email': 'aamestoy@ch-perrens.fr', 'phone': '05 56 56 67 19'}, {'name': 'Helen SAVARIEAU', 'role': 'CONTACT', 'email': 'hsavarieau@ch-perrens.fr', 'phone': '05 56 56 35 56'}], 'overallOfficials': [{'name': 'Anouck AMESTOY, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Charles Perrens, Bordeaux', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}