NCT05998473

Brief 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.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

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

June 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

August 7, 2023

Last Update Submit

August 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Coefficient of variation in step length

    Coefficient of variation in step length during 8-meter comfortable walking test

    30 seconds

Study Arms (2)

Normal pressure hydrocephalus

Patients with a diagnosis of normal pressure hydrocephalus and who performed a gait analysis in laboratories

Diagnostic Test: Dynamic stability measurement

Parkinson's disease

Patients with a diagnosis of Parkinson's disease and who performed a gait analysis in laboratories

Diagnostic Test: Dynamic stability measurement

Interventions

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

Normal pressure hydrocephalusParkinson's disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with normal pressure hydrocephalus or Parkinson's disease.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire Analyse et Restauration du Mouvement

Créteil, France

Location

MeSH Terms

Conditions

HydrocephalusParkinson DiseaseMobility LimitationMovement DisordersGait Ataxia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAtaxiaDyskinesiasNeurologic ManifestationsGait Disorders, Neurologic

Study Officials

  • Emilie Hutin

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-director of laboratory

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 21, 2023

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations