Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance
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|ClinicalTrials.gov Identifier: NCT03845725|
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : March 10, 2020
|Condition or disease|
|Parkinson's Disease Falls Balance Urinary Bladder Diseases|
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 Type :||Observational|
|Actual Enrollment :||55 participants|
|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|
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
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
|Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital|
|Ordu, Altınordu, Turkey, 52200|
|Principal Investigator:||Aslıhan Çatıker, Phd||T.C. ORDU ÜNİVERSİTESİ|