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Effect of Need to Void on Parkinsonian Gait

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ClinicalTrials.gov Identifier: NCT03314610
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gérard Amarenco, Pierre and Marie Curie University

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

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Parkinsonism Gait Disorders, Neurologic Other: Gait speed

Detailed Description:

Parkinsonian syndromes are common causes of gait disorders, associated with hypometria, bradykinesia or rigidity. If motor disorders are the most visible part, lower urinary tract dysfunction is one of the most prevalent dysautonomic disorder (27-80%), especially over active bladder syndrome (OAB). If it seems evident that gait and urinary disorders are linked, because of similar anatomic pathways and control processes, no studies have investigated their association in extrapyramidal patients.

The aim of this study is to assess the effect of the need to void on the walking speed in this particular population.

This prospective study inclues all parkinsonian syndromes who had a follow-up for OAB. They must have a security delay over five minutes, no severe cognitive, motor or psychiatric disorders. We invite them to drink until a need to void (or equivalent). Bladder filling is measured by bladder scan, then they performe gait tests in a specific place, with calm and no passage : Patient can use their habitual walking device. Speed walk asking is comfortable for the two test. Three ten-meter tests, one double-task ten-meter test, one timed-up-and-go test, one timed raise of the floor (GMT). We repeat the same tests after voiding or self-catheterization. Toilets are just next to the hall where they realize the tests. A clinical examination assesses urinary dysfunction (USP, IPSS), motor score (UPDRS-III, Hoehn and Yahr scale, daily equivalent of levodopa), history of falls and comorbidities.


Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Need to Void on Parkinsonian Gait
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : December 28, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
No intervention, only propose water and wait for need to void




Primary Outcome Measures :
  1. Gait Speed [ Time Frame: [Time Frame: 1 Day: at strong desire to void and just after void] ]
    Gait speed calculated from 10 meter walk test. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated.


Secondary Outcome Measures :
  1. Time for Timed up and Go [ Time Frame: [Time Frame: 1 Day: at strong desire to void and just after void] ]
    1 record is done for timed up and go test. Time is recorded by a manual chronometer

  2. Time for GMT [ Time Frame: [Time Frame: 1 Day: at strong desire to void and just after void] ]
    1 record is done for GMT , time is recorded by a manual chronometer

  3. Variation of gait speed [ Time Frame: [Time Frame: 1 Day: at strong desire to void and just after void] ]
    Standard deviation and Coefficient of variation is calculated from the 3 records of 10 meter walk test.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting in a tertiary center in neuro-urology
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314610


Contacts
Contact: Etienne SAVARD, Resident +33156017040 greengrc01@gmail.com
Contact: Gérard Amarenco, PhD +33156017040 greengrc01@gmail.com

Locations
France
Service de Neuro-urology, hôpital Tenon Recruiting
Paris, France
Contact: Etienne SAVARD, Resident    +33156017040    greengrc01@gmail.com   
Contact: Gérard Amarenco, PhD    +33156017040    greengrc01@gmail.com   
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
Principal Investigator: Gérard Amarenco, PhD GREEN GRC-01, Neuro-urology, hôpital Tenon

Responsible Party: Gérard Amarenco, Head of Neuro-Urology Department, Tenon Hospital, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT03314610     History of Changes
Other Study ID Numbers: P. GREEN 001
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Lower Urinary Tract Symptoms
Parkinsonian Disorders
Nervous System Diseases
Urological Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurologic Manifestations