Investigation of Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
The aim of this study is to determine the fall and balance conditions of Parkinson's patients according to their urinary complaints.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Orthopedic and / or neurological problem affecting walking or balance skills
- •Not willing to participate in the study
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: Baseline
The TUG is a reliable and valid measurement tool to assess functional mobility in patients with PD
Falls-Efficacy Scale
时间窗: 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.
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
时间窗: 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
时间窗: 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.
Modified Hoehn and Yahr Stage
时间窗: 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
时间窗: Baseline
The BBS consists of 14 items and scores range from 0 (inability to perform the task) to 4 points.
Unified Parkinson's Disease Rating Scale
时间窗: 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
次要结局
未报告次要终点
研究者
Aslıhan ÇATIKER
Principal Investigator
T.C. ORDU ÜNİVERSİTESİ