Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 5:29 PM
Study NCT ID:
NCT04557592
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2020-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020235', 'term': 'Gait Apraxia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001072', 'term': 'Apraxias'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices', 'timeFrame': 'baseline', 'description': 'in the sub-group: Absence of cognitive impairment'}, {'measure': 'Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices', 'timeFrame': 'baseline', 'description': 'in the sub-group: Minor Neurocognitive Disorder'}, {'measure': 'Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices', 'timeFrame': 'baseline', 'description': 'in the sub-group: Major Neurocognitive Disorder'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gait Apraxia', 'Alzheimer Disease', 'Impaired Cognition']}, 'referencesModule': {'references': [{'pmid': '36882705', 'type': 'DERIVED', 'citation': 'Sacco G, Ben-Sadoun G, Gautier J, Simon R, Goupil M, Laureau P, Terrien J, Annweiler C. Comparison of spatio-temporal gait parameters between the GAITRite(R) platinum plus classic and the GAITRite(R) CIRFACE among older adults: a retrospective observational study. BMC Geriatr. 2023 Mar 7;23(1):132. doi: 10.1186/s12877-023-03811-7.'}]}, 'descriptionModule': {'briefSummary': 'The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient \\[ICC\\] \\> 95%) for spatial measures and against video-based (ICC \\> 93%) for temporal measures, and was thus a reliable tools to measure step lengths and times in both walkway center and left-of-center measurements. It was considered as one of the gold standards in gait analyses. This gait analyze system may distinguish prospectively faller and non-faller older adults, but it can detect spatial, temporal, and spatiotemporal measures of gait and greater variability of gait parameters which were associated with and predictive of both global- and domain-specific cognitive decline. Moreover, spatiotemporal gait parameters analyzed using GAITRite® were more disturbed in the advanced stages of dementia, and more affected in the non-AD dementia than in AD suggesting that quantitative gait parameters could be used as a surrogate marker for improving the diagnosis of dementia.\n\nNevertheless, GAITRite® is not a unique system and it comprises different walkways. One of these technologies was a roll-up system (platinum plus classic, RE, Basic and Safari), and the other was a system composed by a changeable association of plates (CIRFACE). In order to ensure a good comparability between studies using these different walkways, it appears important to compare the performances of these walkways in gait analysis. Thus, the main aim of this study was to compare the performances in gait analyze between the GAITRite® platinum plus classic and the GAITRite® CIRFACE among older adults. Secondary aims were to compare these parameters among patients with cognitive complaint, minor or major neurocognitive disorder (NCD) related to Alzheimer disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '74 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients meeting the eligibility criteria over the study period.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 75 years\n* Gait analysis performed with the two walkways superimposed during a consultation or day hospitalization\n\nExclusion Criteria:\n\n* Opposition to the use of the information collected for research purposes'}, 'identificationModule': {'nctId': 'NCT04557592', 'acronym': 'CINERGY', 'briefTitle': 'Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs', 'orgStudyIdInfo': {'id': '2020/110'}}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}