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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845725
• Other study ID #: 2018-09
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2020
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Turkey	Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital	Ordu	Altinordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Berg Balance Scale	The BBS consists of 14 items and scores range from 0 (inability to perform the task) to 4 points.	Baseline
Primary	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
Primary	Timed Up and Go (TUG)	The TUG is a reliable and valid measurement tool to assess functional mobility in patients with PD	Baseline
Primary	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
Primary	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