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

Sponsor
T.C. ORDU ÜNİVERSİTESİ (Other)
Overall Status
Completed
CT.gov ID
NCT03845725
Collaborator
(none)
55
Enrollment
1
Location
16.9
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    55 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Investigation of Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance
    Actual Study Start Date :
    Feb 1, 2018
    Actual Primary Completion Date :
    Jun 30, 2019
    Actual Study Completion Date :
    Jun 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Unified Parkinson's Disease Rating Scale [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 [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 [Baseline]

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

    4. Falls-Efficacy Scale [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) [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) [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital Ordu Altınordu Turkey 52200

    Sponsors and Collaborators

    • T.C. ORDU ÜNİVERSİTESİ

    Investigators

    • Principal Investigator: Aslıhan Çatıker, Phd, T.C. ORDU ÜNİVERSİTESİ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aslıhan ÇATIKER, Principal Investigator, T.C. ORDU ÜNİVERSİTESİ
    ClinicalTrials.gov Identifier:
    NCT03845725
    Other Study ID Numbers:
    • 2018-09
    First Posted:
    Feb 19, 2019
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Urinary Bladder Diseases

    Study Results

    No Results Posted as of Mar 10, 2020