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临床试验/NCT05107531
NCT05107531已完成不适用

Investigation of Gait, Foot Pressure Distribution and Balance in Parkinson's Patients With Motor Freezing

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
KoreBalance Balance Evaluation System

研究概览

简要总结

Parkinson's disease is characterized by cardinal motor signs such as bradykinesia, tremor, rigidity and postural instability. In addition to these findings, motor freezing, gait disorders, posture disorders, decreased arm swings and loss of axial rotation are also seen. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. In addition, gait disorders are common in advanced stages of Parkinson's Disease. Gait disorders decrease the quality of life by increasing the risk of falls, fractures and mortality. Therefore, the aim of this study is to observe the change in gait, foot pressure distribution and balance parameters of Parkinson's patients with and without motor deceleration compared to each other and healthy controls and to determine the relationship between these parameters.

详细描述

Parkinson's disease is characterized by basic motor symptoms such as bradykinesia, tremor, rigidity and postural instability. In addition to these findings, motor freezing, gait disorders, posture disorders, decreased arm swings and loss of axial rotation are also seen. Restrictions in balance, mobility and activities of daily living due to motor disorders seen in Parkinson's Disease and related disability, addiction and decrease in quality of life occur. Approximately 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and the quality of life of patients is significantly affected. Also, gait disturbances are common in advanced stages of Parkinson's Disease. Gait disorders reduce the quality of life by increasing the risk of falls, fractures and death. Therefore, the aim of this study is to observe the changes in the gait, foot pressure distribution and balance parameters of Parkinson's patients with and without motor retardation compared to each other and to healthy controls, and to determine the relationship between these parameters.

This research is planned as two sub-work packages. Foot pressure distribution analysis and gait evaluation will be performed in the first sub-work package, and balance evaluation will be performed in the second sub-work package.

From the results of this research, 2 separate articles will be written that evaluate the balance and foot pressure distribution analysis and gait separately.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with idiopathic Parkinson's disease
  • Healthy individuals who do not have musculoskeletal disease or any neurological disease that may affect assessments
  • Being between 50-80 years old
  • Volunteer to participate in the study
  • Grade 2-3 on the Modified Hoehn-Yahr Scale
  • To have a score above 24 in the Standardized Mini Mental Test

排除标准

  • Having an additional neurological or psychiatric disease other than Parkinson's disease
  • Uncontrollable dyskinesia or motor fluctuations
  • Presence of postural hypotension, vision problems (not compensated by the correct lens) or vestibular disorders that may affect balance
  • Presence of cardiopulmonary diseases that may affect gait
  • Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis) and inflammatory arthritis that may cause limitation of movement and affect gait and assessment

结局指标

主要结局

KoreBalance Balance Evaluation System

时间窗: Baseline

KoreBalance is a balance assessment and training system designed with the latest technology. There is a variable air pressure pouch system and tilt sensor under the platform to monitor movements 360° horizontally and 20° vertically. There are dynamic and static balance tests in the device.

E-LINK FP3 Force Plate

时间窗: Baseline

The system allows an accurate and objective assessment of the patient's ability to maintain postural stability on a static surface by measuring the symmetrical weight distribution in both the anterior-posterior and left-right axes. While the patient is standing on the force platform, a timed balance test is performed by the researcher to determine which direction the patient's balance has shifted.

Time Up and Go Test

时间窗: Baseline

The patient is asked to get up from the chair he is sitting in, walk three meters, turn around and sit again. At this time, the time is recorded. 10 seconds or less; It indicates that the patient walks independently, the risk of falling is low, and if it is longer than 30 seconds, it indicates the need for help from time to time and a high risk of falling.

Computerized Gait Assessment System (Zebris Rehawalk)

时间窗: Baseline

In addition to the spatiotemporal characteristics of gait such as gait speed, stride length, double stride length, stride width, cadence, stance and swing phase outputs, the pressure distribution measurement platform integrated into the system allows the measurement of dynamic foot pressure distribution. In addition, kinematic analysis of the gait can be made with the support of the camera in the system.

Functional Reach Test

时间窗: Baseline

The functional reach test is a dynamic test used to evaluate postural control. Participants are asked to reach forward through the ankle joint without moving their hips. Values less than 25.4 cm indicate an increased risk of falling.

次要结局

  • Unified Parkinson's Disease Rating Scale(Baseline)
  • Freezing of Gait Questionnaire(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suleyman Korkusuz

Principal Investigator

Hacettepe University

研究点 (1)

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