Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-10 @ 12:12 AM
Study NCT ID:
NCT03166020
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of the gesture to reach each target', 'timeFrame': '10 minutes', 'description': 'score'}], 'secondaryOutcomes': [{'measure': 'Wolf Motor Functional Test', 'timeFrame': '15 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'Box and block', 'timeFrame': '5 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'Fugl Meyer', 'timeFrame': '10 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'MOCA', 'timeFrame': '5 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'Pain', 'timeFrame': '1 minute', 'description': 'Visual analog scale'}, {'measure': 'Spasticity', 'timeFrame': '5 minutes', 'description': 'Visual analog scale'}, {'measure': 'SF12 Quality of life', 'timeFrame': '10 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'Canadian Occupational Performance Measure', 'timeFrame': '20 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'Frenchay activities Index', 'timeFrame': '15 minutes', 'description': 'Clinical Evaluation'}, {'measure': 'Cinematic Evaluation', 'timeFrame': '10 minutes', 'description': 'Evaluation of the cinematic of the paretic upper limb'}, {'measure': 'Clamping force', 'timeFrame': '2 minutes', 'description': 'composite score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serious Game', 'Stroke', 'Rehabilitation', 'Connected objects'], 'conditions': ['Stroke', 'Motor Activity']}, 'referencesModule': {'references': [{'pmid': '37360348', 'type': 'DERIVED', 'citation': 'Pouplin S, Bonnyaud C, Bouchigny S, Megard C, Bertholier L, Goulamhoussen R, Foulon P, Bensmail D, Barbot F, Roche N. Feasibility of a serious game system including a tangible object for post stroke upper limb rehabilitation: a pilot randomized clinical study. Front Neurol. 2023 Jun 9;14:1176071. doi: 10.3389/fneur.2023.1176071. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke patients\n* Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.\n\nExclusion Criteria:\n\n* Severe cognitive disorders preventing the completion of the task\n* Bilateral brain lesions'}, 'identificationModule': {'nctId': 'NCT03166020', 'acronym': 'ERGOTACT', 'briefTitle': 'Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident', 'orgStudyIdInfo': {'id': '2016-A01903-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation with Interactive Table', 'description': 'Included patients will be invited to participate in 10 sessions, focused on the movement and manipulation of instrumented objects on interactive table with serious game, during 30 minutes per day, 5 days a week, for 14 days. An occupational therapist will be required only for patient installation in front of the table.', 'interventionNames': ['Other: Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self Rehabilitation', 'description': 'Included patients will be instructed to perform 10 self-rehabilitation sessions with 9 exercises (3 stretching, 3 reinforcement, 3 spot-oriented work) during 30 minutes per day, 5 days a week, for 14 days.', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'An occupational therapist will be required only for patient installation in front of the table.', 'armGroupLabels': ['Rehabilitation with Interactive Table', 'Self Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Nicolas ROCHE, Md PhD', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Nicolas ROCHE, MD phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Raymond Poincare HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Garches', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}