NCT02350270

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 29, 2015

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

January 26, 2015

Last Update Submit

January 28, 2015

Conditions

Mild Cognitive ImpairmentMild DementiaModerate DementiaHealthy

Keywords

cognitively healthy individuals

Outcome Measures

Primary Outcomes (1)

  • Spatio-temporal gait parameters

    Spatio-temporal gait parameters were measured at steady state walking using GAITRite®-system.

    This outcome is assessed at inclusion

Secondary Outcomes (2)

  • Clinical assessment

    This outcome is assessed at inclusion

  • Cognitive status

    This outcome is assessed at inclusion

Study Arms (3)

cognitively healthy individuals (CHI)

CHI were participants without objective cognitive impairment

Other: gait and cognitive testing

mild cognitive impairment (MCI)

MCI was diagnosed if participants met the following criteria: presence of spontaneous cognitive complaints and objective cognitive impairment

Other: gait and cognitive testing

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

Other: gait and cognitive testing

Interventions

gait and cognitive testingOTHER
cognitively healthy individuals (CHI)mild and moderate dementiamild cognitive impairment (MCI)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were recruited in each memory clinic by a physician

You may qualify if:

  • Being 60 years old and older
  • Ability to answer questions

You may not qualify if:

  • Opposition to the use of information collected for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

GaitNeuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Olivier Beauchet, MD, PhD

    Angers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Beauchet, MD, PhD

CONTACT

++33 2 41 35 57 38olbeauchet@chu-angers.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

January 29, 2015

Record last verified: 2014-02

Locations

FR(1)