Gait, cOgnitiOn & Decline (GOOD)

Healthy Clinical Trial

Official title:

Gait, cOgnitiOn & Decline (GOOD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02350270
• Other study ID #: 2014-17
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2015
• Last updated: January 28, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: University Hospital, Angers
• Contact: Olivier Beauchet, MD, PhD
• Phone: ++33 2 41 35 57 38
• Email: olbeauchet[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia.

Description:

Gait disorders are frequent in individuals with cognitive disorders. However, the profile of spatio-temporal gait parameters in the different cognitive status in aging (from normal cognition to dementia) has been poorly studied. Determining this profile associated with the severity of cognitive disorders may be helpful to understand the complex interplay between gait and cognitive disorders and, thus, may have important implication for the diagnosis process of patients with and without dementia. For instance, defining a motor phenotype of the severity of cognitive disorders by using quantitative gait measurements could be used to improve the prediction and the diagnosis of dementia.

The investigators hypothesized that, compared to CHI, people with MCI and mild dementia could be characterized by specific phenotypes of spatio-temporal gait parameters measured with the GAITRite® system, and that these profiles could be explained by declines in domain-specific cognitive performance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Being 60 years old and older

• Ability to answer questions

Exclusion Criteria:

• Opposition to the use of information collected for research purposes

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia
• Healthy
• Mild Cognitive Impairment
• Mild Dementia
• Moderate Dementia

Intervention

Other:
• gait and cognitive testing

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Biomathics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatio-temporal gait parameters	Spatio-temporal gait parameters were measured at steady state walking using GAITRite®-system.	This outcome is assessed at inclusion	No
Secondary	Clinical assessment	This outcome was assessed by a questionnaire.	This outcome is assessed at inclusion	No
Secondary	Cognitive status	Cognitive status was assessed by cognitive testing.	This outcome is assessed at inclusion	No