Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-03-26 @ 4:13 PM
Study NCT ID:
NCT05422495
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-01-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go (TUG)', 'timeFrame': 'change between baseline and 6 month'}, {'measure': 'MMSE globale cognitive assesment', 'timeFrame': 'change between baseline and 6 month'}, {'measure': 'Attention assessed by WAIS digit spans', 'timeFrame': 'change between baseline and 6 month'}, {'measure': 'Executive functions assessed by the TMT A AND B', 'timeFrame': 'change between baseline and 6 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fall Patients']}, 'descriptionModule': {'briefSummary': 'Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health.\n\nThe objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged over 60, residing in nursing homes\n* Subjects able to walk 15 meters unaided\n* MMSE \\> 10\n* Visual acuity in both eyes \\> 6/10\n* Affiliated subject or beneficiary of a social security scheme\n* Subject having given and signed an informed consent to participate in the study, or his/her guardian\n* Subject having a sedentary activity or practicing a usual light to moderate physical activity (physical activities \\< 6 METs)\n\nExclusion Criteria:\n\n* Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity\n* Subject with a modification of less than 3 months of psychotropic drugs\n* Subject practicing high intensity physical activity (\\> 6 METs)'}, 'identificationModule': {'nctId': 'NCT05422495', 'acronym': 'GATE', 'briefTitle': 'Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors', 'orgStudyIdInfo': {'id': '19-214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activity', 'description': 'cognitive-motor training : Cycléo device (COTTOS ®),', 'interventionNames': ['Behavioral: training with Cycléo device (COTTOS ®),']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No activity', 'description': 'no training', 'interventionNames': ['Other: non intervention']}], 'interventions': [{'name': 'training with Cycléo device (COTTOS ®),', 'type': 'BEHAVIORAL', 'description': '8 weeks of training', 'armGroupLabels': ['Activity']}, {'name': 'non intervention', 'type': 'OTHER', 'description': 'non intervention', 'armGroupLabels': ['No activity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loggia Gilles', 'role': 'CONTACT', 'email': 'loggia-g@chu-caen.fr', 'phone': '0230063106', 'phoneExt': '+33'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}