Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs

Alzheimer Disease Clinical Trial

— CINERGY  

Official title:

Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557592
• Other study ID #: 2020/110
• Status: Completed
• Start date: June 17, 2019
• Est. completion date: February 26, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Gender: All
• Age group: 74 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Apraxias
• Cognitive Dysfunction
• Gait Apraxia
• Impaired Cognition

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices	in the sub-group: Absence of cognitive impairment	baseline
Primary	Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices	in the sub-group: Minor Neurocognitive Disorder	baseline
Primary	Change in spatiotemporal gait, and in particular in the variability of stride time between the two devices	in the sub-group: Major Neurocognitive Disorder	baseline