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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845725
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Aslıhan ÇATIKER, T.C. ORDU ÜNİVERSİTESİ

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
Parkinson's Disease Falls Balance Urinary Bladder Diseases

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.

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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 : February 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A total of 80 patients who attended the Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital in December 2019 and February 2020 will be evaluated.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845725


Locations
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Turkey
Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital
Ordu, Altınordu, Turkey, 52200
Sponsors and Collaborators
T.C. ORDU ÜNİVERSİTESİ
Investigators
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Principal Investigator: Aslıhan Çatıker, Phd T.C. ORDU ÜNİVERSİTESİ
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Responsible Party: Aslıhan ÇATIKER, Principal Investigator, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier: NCT03845725    
Other Study ID Numbers: 2018-09
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Urinary Bladder Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Urologic Diseases