Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-18 @ 2:39 AM
Study NCT ID:
NCT02469350
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serious Game for Parkinson's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility questionnaire', 'timeFrame': 'once a week', 'description': 'self-assessment questionnaire'}], 'secondaryOutcomes': [{'measure': 'Acceptability questionnaire', 'timeFrame': 'once a week', 'description': 'self-assessment questionnaire'}, {'measure': 'biomechanical parameters of gait and balance', 'timeFrame': 'at inclusion, 3 weeks, 6 weeks and 18 weeks', 'description': 'recordings of centres of foot and mass displacements and velocities'}, {'measure': 'kinematics parameters of gait and balance', 'timeFrame': 'at inclusion, 3 weeks, 6 weeks and 18 weeks', 'description': 'range of motion of hip, knee and ankle angles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gait and balance disorders', 'serious game'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '29636105', 'type': 'RESULT', 'citation': "Nuic D, Vinti M, Karachi C, Foulon P, Van Hamme A, Welter ML. The feasibility and positive effects of a customised videogame rehabilitation programme for freezing of gait and falls in Parkinson's disease patients: a pilot study. J Neuroeng Rehabil. 2018 Apr 10;15(1):31. doi: 10.1186/s12984-018-0375-x."}]}, 'descriptionModule': {'briefSummary': "In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease\n* Gait and balance disorders\n* Chronic bilateral deep brain stimulation of the subthalamic nucleus (\\> 1 year).\n\nExclusion Criteria:\n\n* Dementia\n* Ongoing severe medical condition that prevented assessments"}, 'identificationModule': {'nctId': 'NCT02469350', 'acronym': 'PARKGAME', 'briefTitle': "Serious Game for Parkinson's Disease Patients", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders", 'orgStudyIdInfo': {'id': 'C15-12'}, 'secondaryIdInfos': [{'id': 'RCB', 'type': 'REGISTRY', 'domain': '2015-A00277-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation with serious game', 'description': '18 rehabilitation sessions with serious game during a 6-8 weeks period', 'interventionNames': ['Other: Serious game']}], 'interventions': [{'name': 'Serious game', 'type': 'OTHER', 'description': 'Rehabilitation with serious game', 'armGroupLabels': ['Rehabilitation with serious game']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'ICM, CIC Neurosciences', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marie-Laure Welter, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHPS, APHP, Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}