NCT06333119

Brief Summary

There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Keywords

strokeurinary incontinencespasticitybalancegait

Outcome Measures

Primary Outcomes (1)

  • relationship with between urinary incontinence and motor symptoms

    correlation analysis was done.

    4 months

Study Arms (1)

individuals with stroke

Diagnostic Test: modified rankin scale

Interventions

modified rankin scaleDIAGNOSTIC_TEST

Modified Rankin Scale: The functional status of individuals with stroke is determined by this scale. Modified Ashworth Scale: It allows determining the severity of spasticity. Tinetti Balance and Gait Scale: This scale helps determine the risk of falling by evaluating balance and gait. Danish Prostatic Symptom Score: It allows to evaluate the storage and urinary functions of the bladder.

Also known as: modified ashworth scale, Tinetti Balance and Gait Scale, Danish Prostatic Symptom Score
individuals with stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals with stroke

You may qualify if:

  • Being 18 years old, having a stroke history of at least 3 months, having had only one stroke, scoring between 0-2 points according to MRS, being able to stand and walk independently or with a walking aid, being able to speak Turkish.

You may not qualify if:

  • Those with incomprehensible speech disorders,
  • Those who have additional neurological diseases other than stroke,
  • orthopedic, cardiovascular, etc., which may cause balance disorders. those with illnesses,
  • those who are pregnant,
  • Those with vision and hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeUrinary IncontinenceMotor Skills DisordersMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic Manifestations

Study Officials

  • Pinar Yasar

    Suleyman Demirel University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research assistant, Physiotherapist

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

September 1, 2023

Primary Completion

January 31, 2024

Study Completion

February 15, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

It was decided not to share the data, taking into account the personal data protection law.

Locations