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Gait Disorders in Patients With Cognitive Decline

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ClinicalTrials.gov Identifier: NCT03399591
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date January 8, 2018
First Posted Date January 16, 2018
Last Update Posted Date July 6, 2018
Actual Study Start Date May 2, 2017
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2018)
walking test [ Time Frame: 1 hour after inclusion ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03399591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gait Disorders in Patients With Cognitive Decline
Official Title Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient over the age of 50 with a gait disorder
Condition Gait Disorders, Neurologic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 8, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Refusal to participate in the study

Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jérémie PERISSE, MD 33 3 88 11 55 11 jeremie.perisse@chru-strasbourg.fr
Contact: Candice Muller, MD 33 3 88 11 55 11 candice.muller@chru-strasbourg.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03399591
Other Study ID Numbers 6963
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators
Principal Investigator: Jérémie PERISSE, MD University Hospital, Strasbourg, France
PRS Account University Hospital, Strasbourg, France
Verification Date January 2018