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

NCT03845725 | Completed

• 1 other identifier: 2018-09
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease; Falls; Balance; Urinary Bladder Diseases

Outcome Measures

Primary Outcomes (7)

• Unified Parkinson's Disease Rating Scale

  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

  Baseline

• Modified Hoehn and Yahr Stage

  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.

  Baseline

• Berg Balance Scale

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

  Baseline

• Falls-Efficacy Scale

  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.

  Baseline

• Timed Up and Go (TUG)

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

  Baseline

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

  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.

  Baseline

• Overactive Bladder Version-8

  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.

  Baseline

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Aslıhan Çatıker, Phd

  Ordu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 19, 2019
• Study Start: February 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)