Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs (CINERGY)

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ClinicalTrials.gov Identifier: NCT04557592

Recruitment Status : Completed

First Posted : September 21, 2020

Last Update Posted : September 21, 2020

Sponsor:

Information provided by (Responsible Party):

University Hospital, Angers

Study Description

Brief Summary:

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.

Nevertheless, 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.

Condition or disease
Gait Apraxia Alzheimer Disease Impaired Cognition

Study Design

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Study Type :	Observational
Actual Enrollment :	98 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs
Actual Study Start Date :	June 17, 2019
Actual Primary Completion Date :	February 26, 2020
Actual Study Completion Date :	February 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease Apraxia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices [ Time Frame: baseline ]
in the sub-group: Absence of cognitive impairment
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices [ Time Frame: baseline ]
in the sub-group: Minor Neurocognitive Disorder
Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices [ Time Frame: baseline ]
in the sub-group: Major Neurocognitive Disorder

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	74 Years and older (Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Probability Sample

Study Population

All consecutive patients meeting the eligibility criteria over the study period.

Criteria

Inclusion Criteria:

Age ≥ 75 years
Gait analysis performed with the two walkways superimposed during a consultation or day hospitalization

Exclusion Criteria:

Opposition to the use of the information collected for research purposes

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557592

Locations

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France
Angers University Hospital
Angers, France, 49933

Sponsors and Collaborators

University Hospital, Angers

More Information

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Responsible Party:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT04557592
Other Study ID Numbers:	2020/110
First Posted:	September 21, 2020 Key Record Dates
Last Update Posted:	September 21, 2020
Last Verified:	September 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Alzheimer Disease Apraxias Gait Apraxia Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies	Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Psychomotor Disorders Neurobehavioral Manifestations Neurologic Manifestations Cognition Disorders Gait Disorders, Neurologic

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