- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03204747
Effect of Need to Void on Gait Speed in Multiple Sclerosis
Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor disorders are the most visible disability, urinary disorders are frequent, with prevalence from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions. The seconds are due to specific lesion in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that walk and urinary disorders are link, because of similar anatomic ways and control process. Effect of bladder filling is well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown, while medullary integration of these two functions is very close, in medullary cone.
Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link with major walk impairment when patients need to void.
Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.
History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home.
Walk tests are realized in a specific place, with calm and no passage. A chair is placed at each end of the path. Toilets are just next to the hall where they realize the tests. A 10 Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and go is done. Patient can use their habitual walking device. Speed walk asking is comfortable for the two test.
Next, patient can urinate. 3 post void residual volume with portable echography are done, and the higher is recorded.
Patient achieve the same walk tests after urinate, in the same order. They must use the same walking device.
Primary outcome is mean gait recorded for 10 meters walk test.
Secondary outcome is time for timed up and go test.
Individual variability between the 3 10MWT in the two conditions will be study.
Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment will be study in secondary analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75020
- Service de Neuro-urology, hôpital Tenon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Multiple sclerosis
- Follow in neuro-urology for lower urinary tract symtpoms
- Able to walk 50 meters without human assistance
- able to hold on void during 3 minutes at least
Exclusion Criteria:
- actual urinary tract infection
- relapse in the last week
- Mini Mental State Examination < 10
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients enrolled
Patient with multiple sclerosis 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 will be at strong desire to void. A second record will be after void Gait records consist on : 3 10meter walk test and 1 Timed up and Go test. |
No intervention, only propose water and wait for need to void
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait speed
Time Frame: 1 Day: at strong desire to void and just after void
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Gait speed calculated from 10 meter walk test.
Only the 6 intermediate meters are recorded.
Time is recorded by a manual chronometer.
3 records are done, mean time is calculated.
Mean time is divided by 6 to obtain mean gait speed
|
1 Day: at strong desire to void and just after void
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for Timed up and Go
Time Frame: 1 Day: at strong desire to void and just after void
|
1 record is done for timed up and go test after a first training.
Time is recorded by a manual chronometer
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1 Day: at strong desire to void and just after void
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Variation of gait speed
Time Frame: 1 Day: for strong desire to void and post void
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Coefficient of variation is calculated from the 3 records of 10 meter walk test.
It correspond to standard deviation/average.
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1 Day: for strong desire to void and post void
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P GREEN 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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