Effect of Need to Void on Parkinsonian Gait

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Effect of Need to Void on Parkinsonian Gait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314610
• Other study ID #: P. GREEN 001
• Status: Completed
• Start date: October 16, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: September 2019
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 30, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Lower Urinary Tract Symptoms
• Nervous System Diseases
• Parkinsonian Disorders
• Parkinsonism

Intervention

Other:
• Gait speed
No intervention, only propose water and wait for need to void

Locations

Country	Name	City	State
France	Service de Neuro-urology, hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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]