NCT03399591

Brief Summary

The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools. This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill. The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support. These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 6, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

January 8, 2018

Last Update Submit

July 4, 2018

Conditions

Keywords

Gait DisordersSpatio-temporal parameters of walkingAlzheimer's diseaseLewy body disease

Outcome Measures

Primary Outcomes (1)

  • walking test

    1 hour after inclusion

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient over the age of 50 with a gait disorder

You may qualify if:

  • Patient over 50
  • Hospitalized patient in day hospital
  • Patient with an etiological diagnosis of his cognitive disorder
  • Patient having a neuropsychological assessment
  • Patient able to walk without technical help
  • Patient having agreed to participate in the study

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gériatrie Hôpital de la Robertsau

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Gait Disorders, NeurologicMobility LimitationAlzheimer DiseaseLewy Body Disease

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Officials

  • Jérémie PERISSE, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

May 2, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 6, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations