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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05998473
Other study ID # 2023-A01762-43
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source Henri Mondor University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.


Description:

Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait, similar to disorders in Parkinson's disease. No studies in the literature have focused on advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and in particular dynamic stability as part of additional assessments to help patients follow up. Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly benefit from these assessments. Retrospective analysis of all these data would help to better characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from those associated with Parkinson's disease. It would lead to the definition of relevant indices to be used for patient follow-up.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Age >18 years - Patient who performed a walking test in the Laboratory Analysis and Restoration of Movement - Diagnosis of normal pressure hydrocephalus or Parkinson's disease Exclusion Criteria: - Levodopa drugs administrated during a delay of 12 hours before walking test - Presence of an other neurologic disease or of any disease associated with motor disorders in lower limb.

Study Design


Intervention

Diagnostic Test:
Dynamic stability measurement
The subject is asked to walk 8 meters 3 times: at free speed, at fast speed, and with large steps.

Locations

Country Name City State
France Laboratoire Analyse et Restauration du Mouvement Créteil

Sponsors (1)

Lead Sponsor Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coefficient of variation in step length Coefficient of variation in step length during 8-meter comfortable walking test 30 seconds
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