NCT03314610

Brief Summary

This study evaluates the effect of the need to void on parkinsonian gait

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 15, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

October 15, 2017

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gait Speed

    Gait speed calculated from 10 meter walk test. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated.

    [Time Frame: 1 Day: at strong desire to void and just after void]

Secondary Outcomes (3)

  • Time for Timed up and Go

    [Time Frame: 1 Day: at strong desire to void and just after void]

  • Time for GMT

    [Time Frame: 1 Day: at strong desire to void and just after void]

  • Variation of gait speed

    [Time Frame: 1 Day: at strong desire to void and just after void]

Study Arms (1)

Patients enrolled

Patient with parkinsonian syndromes and lower urinary tract symptoms, age \> 18, able to walk without human help on 50 meters, able to hold urine at least 3 minutes. A first record of gait speed will be at strong desire to void. A second record will be after voiding or catheterization Gait records consist on : 3x 10 meter walk test, 1x double task 10 meter walk test, 1x Timed up and Go test and 1x GMT

Other: Gait speed

Interventions

No intervention, only propose water and wait for need to void

Patients enrolled

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting in a tertiary center in neuro-urology

You may qualify if:

  • Parkinsonian syndromes
  • Follow in neurourology for Lower urinary tract symptoms
  • Able to walk 50 meters without human assistance
  • able to hold voiding for more than 3 minutes

You may not qualify if:

  • Actual urinary tract infection
  • Montreal cognitive assessment \< 20/30
  • Acute psychiatric or neurologic disorders who can interfer with walking tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neuro-urology, hôpital Tenon

Paris, France

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsParkinsonian DisordersGait Disorders, Neurologic

Interventions

Walking Speed

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersNeurologic Manifestations

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gérard Amarenco, PhD

    GREEN GRC-01, Neuro-urology, hôpital Tenon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neuro-Urology Department, Tenon Hospital

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 19, 2017

Study Start

October 16, 2017

Primary Completion

December 28, 2017

Study Completion

December 30, 2017

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations