Effect of Need to Void on Parkinsonian Gait

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

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Parkinsonism; Gait Disorders, Neurologic
• Intervention / Treatment: 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
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Service de Neuro-urology, hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in a tertiary center in neuro-urology

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for Timed up and Go	1 record is done for timed up and go test. Time is recorded by a manual chronometer	[Time Frame: 1 Day: at strong desire to void and just after void]
Time for GMT	1 record is done for GMT , time is recorded by a manual chronometer	[Time Frame: 1 Day: at strong desire to void and just after void]
Variation of gait speed	Standard deviation and Coefficient of variation is calculated from the 3 records of 10 meter walk test.	[Time Frame: 1 Day: at strong desire to void and just after void]

Collaborators and Investigators

• Sponsor: Pierre and Marie Curie University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): December 28, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 15, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Urological Manifestations; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Lower Urinary Tract Symptoms; Nervous System Diseases; Parkinsonian Disorders; Gait Disorders, Neurologic
• Other Study ID Numbers: P. GREEN 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No