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The Mediating Role of Balance in the Relationship Between Fatigue and Fear of Falling in Individuals With Multiple Sclerosis

2026年9月7日 更新者:Uskudar University
Fatigue, balance impairment, and fear of falling are common problems in individuals with Multiple Sclerosis (MS). Previous studies have shown significant associations among these variables; however, the mechanisms underlying the relationship between fatigue and fear of falling remain unclear. It is possible that fatigue increases fear of falling indirectly through its negative effects on balance performance.

研究概览

详细说明

Multiple sclerosis (MS) is a chronic demyelinating and neurodegenerative disease of the central nervous system that frequently leads to fatigue, balance impairment, and fear of falling. These symptoms negatively affect mobility, independence, participation in daily activities, and quality of life. Fatigue is one of the most common and disabling symptoms in individuals with MS and may contribute to impaired balance and an increased risk of falls.

Fear of falling is highly prevalent in people with MS and is associated with reduced physical activity, activity avoidance, and functional decline. Balance impairment is another common manifestation of MS and may represent an important mechanism linking fatigue to fear of falling. However, although fatigue, balance, and fear of falling have been investigated separately, the mediating role of balance in the relationship between fatigue and fear of falling has not been sufficiently explored.

The aim of this cross-sectional observational study is to investigate whether balance mediates the relationship between fatigue and fear of falling in individuals with multiple sclerosis. Fatigue will be assessed using the Fatigue Severity Scale (FSS), balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest), and fear of falling will be measured using the Falls Efficacy Scale-International (FES-I).

The findings of this study are expected to improve the understanding of the mechanisms underlying fear of falling in individuals with MS and provide evidence to support the development of rehabilitation programs targeting balance to reduce fear of falling and improve functional outcomes.

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

The study population will consist of adults diagnosed with multiple sclerosis who are clinically stable and able to complete the study assessments. Eligible participants will be recruited from the outpatient neurology and physical medicine and rehabilitation clinics of Başkent University.

描述

Inclusion Criteria:

  • Age 18-65 years
  • Neurologist-confirmed MS diagnosis
  • No relapse within the previous 30 days
  • Ability to walk independently or with an assistive device
  • Ability to understand instructions
  • Voluntary participation

Exclusion Criteria:

  • Recent MS relapse
  • Severe vestibular disorder
  • Other neurological diseases
  • Severe orthopedic conditions affecting mobility
  • Recent lower extremity surgery or trauma
  • Cardiopulmonary conditions limiting assessment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Individuals with Multiple Sclerosis
Adults diagnosed with multiple sclerosis who meet the eligibility criteria will participate in a single assessment session to evaluate fatigue, balance, and fear of falling.
Observational Model: Cross-Sectional

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Falls Efficacy Scale-International
大体时间:Time Frame: Baseline (single assessment)
Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire that evaluates concern about falling during a range of daily activities. Total scores range from 16 to 64, with higher scores indicating greater fear of falling.
Time Frame: Baseline (single assessment)

次要结果测量

结果测量
措施说明
大体时间
Fatigue Severity Scale (FSS)
大体时间:Baseline (single assessment)
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The FSS consists of 9 items rated on a 7-point Likert scale. The total score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.
Baseline (single assessment)
Baseline (single assessment)
大体时间:Baseline (single assessment)
Balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest consists of 14 items assessing dynamic balance. Total scores range from 0 to 28, with higher scores indicating better balance performance.
Baseline (single assessment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (实际的)

2026年9月1日

研究完成 (实际的)

2026年9月1日

研究注册日期

首次提交

2026年6月25日

首先提交符合 QC 标准的

2026年6月25日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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