Gait and Alzheimer Interaction Tracking (GAIT) Study

Alzheimer Disease Clinical Trial

— GAIT  

Official title:

Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315717
• Other study ID #: 2009-A00533-54
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: September 21, 2016
• Start date: November 2009
• Est. completion date: May 2016

Study information

• Verified date: March 2011
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Description:

Although gait disorders are frequently associated with Alzheimer's disease (AD), few studies have focused on their characterization and mechanism. Exploring the associations of the gait characteristics - more particularly the gait variability - with the cognitive performance of AD patients on one hand, and with the morphological brain abnormalities on the other hand, could be useful to understanding the mechanisms of gait disorders in AD.

The main objective of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age = 60 years

• Able to walk without walking aid on 15 metres

• Score of Mini-Mental Examination (MMSE) > 10

• Written informed consent to participate in the study (or trustworthy person)

• Being affiliated to a social security regime

• Near visual acuity = 2/10

• Absence of severe depression (score in the 15-item Geriatric Depression Scale = 10)

Exclusion Criteria:

• Score of Mini-Mental Examination (MMSE) = 10

• Subject suffering from pre-existing impellent disturbances

• History of cerebrovascular accident or other cerebro-spinal pathology

• Poor workmanship of the written or oral French language

• Refusal of subject to be informed on possible hanging bare anomaly during study

• Use of walking aid

• Acute medical or surgical disease in the past 3 months

• Refusal to participate (or trustworthy person)

• Contra-indication to the achievement of a Magnetic Resonance Imaging

• Near visual acuity < 2/10

• Presence of severe depression (score in the 15-item Geriatric Depression Scale > 10)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alzheimer Disease
• Apraxias
• Atrophy
• Cerebral Atrophy
• 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	Stride-to-stride variability of stride time		baseline	No