Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease (HPGAIT)

August 16, 2023 updated by: Emilie Hutin, Henri Mondor University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Laboratoire Analyse et Restauration du Mouvement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with normal pressure hydrocephalus or Parkinson's disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal pressure hydrocephalus
Patients with a diagnosis of normal pressure hydrocephalus and who performed a gait analysis in laboratories
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.
Parkinson's disease
Patients with a diagnosis of Parkinson's disease and who performed a gait analysis in laboratories
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of variation in step length
Time Frame: 30 seconds
Coefficient of variation in step length during 8-meter comfortable walking test
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henri Mondor University Hospital

Investigators

  • Principal Investigator: Emilie Hutin, Henri Mondor University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01762-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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