Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-26 @ 12:18 PM
Study NCT ID:
NCT02885493
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2016-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Dysfunction of the Basal Ganglia Before a Parkinsonian Walking in the Elderly: Risk of Falling and Confusional State
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'falls risks', 'timeFrame': 'number of falls during follow-up of 24 months', 'description': 'Assess Falls development risk in the presence of parkinsonian walking'}], 'secondaryOutcomes': [{'measure': 'number of confusional states', 'timeFrame': 'follow-up of 24 months'}, {'measure': 'number of hospitalizations', 'timeFrame': 'follow-up of 24 months'}, {'measure': 'mortality', 'timeFrame': 'follow-up of 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson march'], 'conditions': ['the Elderly']}, 'referencesModule': {'references': [{'pmid': '36921515', 'type': 'DERIVED', 'citation': 'Kiesmann M, Martin RE, Sauleau E, Bulubas I, Fleury MC, Perisse J, Kaltenbach G, Schmitt E. Diagnosis of vascular parkinsonism: A new tool for gait hypokinesia occurring in older persons. Parkinsonism Relat Disord. 2023 Apr;109:105360. doi: 10.1016/j.parkreldis.2023.105360. Epub 2023 Mar 8.'}, {'pmid': '35152218', 'type': 'DERIVED', 'citation': 'Kiesmann M, Sauleau E, Ewald Martin R, Danan J, Sauer A, Konrad S, Blanc F, Vogel T, Kaltenbach G, Schmitt E. Older Persons Displaying Parkinsonian Gait: Prediction and Explanation of the Recurrent Falling Phenomenon and Its Related Poor Prognosis. Gerontology. 2022;68(12):1402-1414. doi: 10.1159/000521503. Epub 2022 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'The strong relationship between falling and severity of cognitive impairment in the elderly is well established. The association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. The gait fortiori neurological are fall risk factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are subcortical origin involving so the basal ganglia. This study is indeed based on the assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with cognitive impairment and greater susceptibility to confusional states. The executive disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye movements, impaired vision contrasts are well established in the degenerative parkinsonian syndromes. This study proposes a new approach to assessing gait disorders to define a high risk of falling in the presence of parkinsonian walking in the elderly over 75 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the eldery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 75 years,\n* man or woman,\n* Diagnostic Criteria for Parkinson walking: at least 3 of the following symptoms:\n* Loss of swinging arms,\n* Decrease in stride walking slowly,\n* feet as glued to the ground,\n* Trample,\n* piece U-turn,\n* kyphotic Attitude,\n* Tolerance screw physiotherapy screws\n\nExclusion Criteria:\n\n* Unrecovered delirium,\n* Unable to walk for a distance of 6 meters in length without technical assistance,\n* Traumatic fall phase of rehabilitation,\n* Acute pathology,\n* Unstabilized psychiatric pathology,\n* Symptomatic orthostatic hypotension,\n* Severe depressive syndrome untreated\n* Subjects with a sufficient gap to explain the falls:\n\n * cerebellar syndrome,\n * a pyramidal syndrome with sequelae pyramidal deficit and cortical stroke\n * peripheral pathology,\n * rheumatic disease,\n * orthopedic pathology,\n* Mini Metam State Examination \\<18,\n* Parkinsonism induced by neuroleptics,\n* Not cured cancer,\n* Psychotropic drugs (benzodiazepines and antipsychotics) with significant sedative effect inducing excessive daytime sleepiness namely psychotropic half long life, and high dose over 2 psychotropic\n* Severe heart failure\n* Severe respiratory failure,\n* Associated diseases and treatments interfering'}, 'identificationModule': {'nctId': 'NCT02885493', 'acronym': 'EVAMARAGEX', 'briefTitle': 'Evaluation of Dysfunction of the Basal Ganglia Before a Parkinsonian Walking in the Elderly: Risk of Falling and Confusional State', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.", 'orgStudyIdInfo': {'id': '5955'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Falls is <or = 1 year', 'description': 'Patients whose number of falls is \\<or = 1 year', 'interventionNames': ['Behavioral: tests']}, {'label': 'falls is> 1 year', 'description': 'Patients whose numbers falls is\\> 1 year', 'interventionNames': ['Behavioral: tests']}], 'interventions': [{'name': 'tests', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Falls is <or = 1 year', 'falls is> 1 year']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Michèle KIESMANN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}