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临床试验/NCT04547400
NCT04547400已完成不适用

Relationship of Position Sense With Gait and Balance in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月5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
40
试验地点
1
主要终点
Balance

研究概览

简要总结

Balance and gait disturbances are among the most common problems in patients with Multiple Sclerosis (MS). There is evidence of decreased foot sole sensation in MS patients. Studies conducted in healthy individuals have revealed the relationship between balance and foot sole sensation. These studies have demonstrated that sensory feedback from the cutaneous receptors of the foot sole plays an important role in maintaining balance. However, it is not yet known clearly to what extent the sensory impairment seen in MS patients affects balance and gait disorders.

The aim of this study is to examine the relationship between lower extremity position sense and foot sole sense with gait and balance in MS patients.

详细描述

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The balance, gait, lower extremity position sense, and foot sole sense will be evaluated.

The researchers will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. In addition, the researchers will examine the correlations between balance, gait, lower extremity position sense, and foot sole using by Pearson bivariate correlations.

研究设计

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

入排标准

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

入选标准

  • 18-65 years of age Having a diagnosis of "Multiple Sclerosis" by a specialist physician Relapse free in the last 3 mounts Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 ) No diagnosis of depression

排除标准

  • Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research

结局指标

主要结局

Balance

时间窗: 10 minutes

The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform.

Gait

时间窗: 5 minutes

Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica

次要结局

  • Light touch-pressure sensation(10 minutes)
  • Vibration sensation(10 minutes)
  • Knee proprioception(10 minutes)
  • Two-point discrimination(10 minutes)
  • position sensation of knee joint(5 minutes)

研究者

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

Cagla Ozkul

Research Assistant

Gazi University

研究点 (1)

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