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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

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

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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





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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

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
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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