- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02350270
Gait, cOgnitiOn & Decline (GOOD)
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Angers, France, 49933
- Recruiting
- University Hospital
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Contact:
- Olivier Beauchet, MD, PhD
- Phone Number: ++33 2 41 35 57 38
- Email: olbeauchet@chu-angers.fr
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Principal Investigator:
- Olivier Beauchet, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cognitively healthy individuals (CHI)
CHI were participants without objective cognitive impairment
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|
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mild cognitive impairment (MCI)
MCI was diagnosed if participants met the following criteria: presence of spontaneous cognitive complaints and objective cognitive impairment
|
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mild and moderate dementia
Diagnoses of dementia were assigned according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV TR, 2000; Association, 2000; 22) at consensus diagnostic case conferences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spatio-temporal gait parameters
Time Frame: This outcome is assessed at inclusion
|
Spatio-temporal gait parameters were measured at steady state walking using GAITRite®-system.
|
This outcome is assessed at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical assessment
Time Frame: This outcome is assessed at inclusion
|
This outcome was assessed by a questionnaire.
|
This outcome is assessed at inclusion
|
|
Cognitive status
Time Frame: This outcome is assessed at inclusion
|
Cognitive status was assessed by cognitive testing.
|
This outcome is assessed at inclusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olivier Beauchet, MD, PhD, Angers University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-17
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