NCT04557592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 15, 2020

Last Update Submit

September 15, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age74 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Opposition to the use of the information collected for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49933, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Gait ApraxiaAlzheimer DiseaseCognition Disorders

Condition Hierarchy (Ancestors)

Gait Disorders, NeurologicNeurologic ManifestationsNervous System DiseasesApraxiasPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 21, 2020

Study Start

June 17, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations