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临床试验/NCT04420910
NCT04420910已完成不适用

Investigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Balance

研究概览

简要总结

The purposes of this study is to examine balance, muscle strength, and mobility in relation with non-motor symptoms (NMSs) in patients with Parkinsosn's Disease (PD).

NMSs have been shown to be the key determinant of health-related quality of life (HRQoL) and have a greater effect on HRQoL compared to motor symptoms.Despite a growing literature on NMSs, there are few data on the association between NMSs and motor phenotypes of PD, and they have usually focused only on specific domains of NMSs, such as cognition, mood/anxiety issues, or sleep disorders.

When literature is examined, there is no study which examines balance, muscle strength, and mobility in relation with NMSs in patients with PD.For all these reasons, we think that balance, muscle strength, mobility, and NMSs in patients with PD are worse than those of the healthy individuals and that there is a relationship between NMSs and motor symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being diagnosed with PD by a neurologist, being in Hoehn & Yahr Stage 1-3, having no musculoskeletal system problems in the previous 6 months, having a score of 24 or more in the Mini-Mental State Examination (MMSE), and being volunteer.

排除标准

  • Healthy individuals of similar age and sex, without neurological problems, and who did not experience any musculoskeletal system problems in the previous 6 months were included in the control group.

结局指标

主要结局

Balance

时间窗: one hour

To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used.The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements. As a result, overall stability and anteroposterior and mediolateral indexes were taken into account, and low values indicate high postural stability.

Non-Motor Symptoms

时间窗: one hour

Non-motor symptoms of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS).Each item of the scale is scored between 0 and 30, with "yes" 1 point and "no" 0 point. According to the scoring result, "0" indicates no NMSs, "1-5" indicates mild NMSs, "6-9" indicates medium NMSs, "10-13" indicates heavy NMSs, and "≥14" indicates very heavy NMSs.

Functional mobility

时间窗: one hour

The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. Dual task performance was performed by adding cognitive and motor tasks into the TUG.. As the time increases, dual task performance decreases.

Lower limb strength

时间窗: one hour

A Biodex® System 4 Dynamometer device was used to evaluate muscle strength.Maximal concentric knee flexion and extension muscle strength was measured at 90 degrees/sec angular velocity with 5 repetition \[19\]. The flexion and extension peak torque (PT) values, peak torque/body weight (PT/BW) ratio, and hamstring/quadriceps (H/Q) ratio were recorded. Low values indicate decreased muscle strength.

次要结局

未报告次要终点

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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