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Completed

NCT Number: NCT03845725

Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance

The aim of this study is to determine the fall and balance conditions of Parkinson's patients according to their urinary complaints.

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Key information

Conditions

Parkinson's Disease Balance Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Falls Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital

Ordu, Altınordu, 52200, Turkey (Türkiye)

About this study

Parkinson's disease (PD) is a slowly progressive and common neurodegenerative disease.Frequently encountered problems in lower urinary tract complaints; Bladder dysfunction, such as urinary entrapment and frequent urination.Urinary incontinence in individuals with Parkinson's disease increases the risk of falling.

The investigators will evaluate 80 patients who attended the Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital in December 2018 and February 2019, and were diagnosed as having Parkinson's disease. Other eligibility criteria for participants were having good cognitive functions (>24 on Standardized Mini Mental Test) and were volunteers who accept to participate in the study. The investigators excluded patients that having orthopedic and / or neurological problem affecting walking and balance skills. The investigators used Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn and Yahr Stage (H/Y), Berg Balance Scale (BBS), Falls-Efficacy Scale (FES), Timed Up and Go (TUG), and Five Times Sit to Stand Test (FTSTS), ICIQ-SF and Overactive Bladder Version-8.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease according to the United Kingdom Brain Bank diagnostic criteria
  • Good cognitive functions (>24 on Standardized Mini Mental Test)
  • volunteers who accept to participate in the study.

Exclusion criteria

  • Orthopedic and / or neurological problem affecting walking or balance skills
  • Not willing to participate in the study

Treatment and study plan

Primary outcomes

  1. Unified Parkinson's Disease Rating Scale

    Time frame: Baseline

    The UPDRS is used as a gold standard reference scale. Each item is scored using a 5-point scale, where 0 means an absence of symptoms and 4 represents the worst stage

  2. Modified Hoehn and Yahr Stage

    Time frame: Baseline

    The severity of PD was determined using the Modified Hoehn and Yahr Stage, which contains five stages.

    Stage 0: No signs of disease. Stage 1: Unilateral symptoms only. Stage 2: Bilateral symptoms. No impairment of balance. Stage 3: Balance impairment. Mild to moderate disease. Physically independent. Stage 4: Severe disability, but still able to walk or stand unassisted. Stage 5: Needing a wheelchair or bedridden unless assisted.

  3. Berg Balance Scale

    Time frame: Baseline

    The BBS consists of 14 items and scores range from 0 (inability to perform the task) to 4 points.

  4. Falls-Efficacy Scale

    Time frame: Baseline

    This scale is used to measure the perceived fear of falling. It comprises 10 questions. The score of the scale change 0-100 and the score above 70 indicates the fear of falling.

  5. Timed Up and Go (TUG)

    Time frame: Baseline

    The TUG is a reliable and valid measurement tool to assess functional mobility in patients with PD

  6. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

    Time frame: Baseline

    ICIQ-SF is a short, easy-to-understand and feasible questionnaire form, which demonstrates the reliability and validity of urinary incontinence and its impact on quality of life. In ICIQ-SF questionnaire, the frequency, amount, type and effects of urinary incontinence on the daily life are questioned and scoring is performed between 0-21 values.

  7. Overactive Bladder Version-8

    Time frame: Baseline

    It is used for screening and diagnosis of overactive bladder. The BBS consists of 8 items. A total score of ≥8 indicates that the respondent may have an overactive bladder. The total score ranges from 0 to 40.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Investigation of Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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