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临床试验/NCT07847827
NCT07847827尚未招募不适用

Factors Associated With Fear of Falling in Stroke

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
The Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

The aim of this study is to evaluate the relationship between fear of falling and motor recovery, stroke duration, trunk control, and balance in stroke patients.

详细描述

Fear of falling is a common and disabling complication in stroke patients during the acute, subacute, and chronic stages. This observational study aims to evaluate the relationship between fear of falling and upper/lower extremity motor recovery, time since stroke, trunk control, and balance in post-stroke individuals. The investigators will assess participants using demographic information, fall history, the Montreal Cognitive Assessment, Brunnstrom Staging for upper and lower extremity motor recovery, the Falls Efficacy Scale International, the Trunk Impairment Scale, and the Tinetti Performance Oriented Mobility Assessment. Additionally, the investigators will evaluate whether clinical parameters such as motor recovery, balance and trunk control correlate with the level of fear of falling.

研究设计

研究类型
观察性
观察模型
其他
时间视角
横断面

入排标准

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

入选标准

  • Having a diagnosis of stroke
  • Aged ≥ 18 years old
  • History of at least one fall
  • Ability to walk 10 meters independently or with an assistive device
  • Ability to understand and follow simple instructions

排除标准

  • Having another neurological disease (except for stroke)
  • Having a surgery upper or lower extremity in the last 6 months
  • Unwillingness to participate

研究组 & 干预措施

Post-stroke patients

Individuals aged 18 and older diagnosed with stroke, who have a history of at least one fall, are able to walk 10 meters independently or with an assistive device, and can understand and follow simple instructions.

结局指标

主要结局

The Montreal Cognitive Assessment (MoCA)

时间窗: Baseline

The Montreal Cognitive Assessment (MoCA) is a 30-point scale comprising 16 items across 11 categories used to screen for cognitive impairment in stroke and other neurological conditions, where a score of 26 or above indicates normal cognitive function.

Brunnstrom Recovery Stages of Upper and Lower Extremity

时间窗: Baseline

The Brunnstrom recovery stages are a staging system that shows the motor recovery in patients with stroke. The Brunnstrom Recovery Stages of Upper and Lower Extremity of six stages. Higher stages indicate better motor function.

Falls Efficacy Scale-International (FES-I)

时间窗: Baseline

The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned). Total score is between 16 and 64 points. Lower scores mean a better outcome.

Trunk Impairment Scale (TIS)

时间窗: Baseline

The Trunk Impairment Scale (TIS) evaluates post-stroke trunk control across three subscales (static sitting balance, dynamic sitting balance, and coordination) with a maximum total score of 23, where higher scores reflect better trunk function.

Tinetti Performance Oriented Mobility Assessment (POMA) - Balance

时间窗: Baseline

The Tinetti Performance Oriented Mobility Assessment (POMA) balance subscale comprises 9 items with a total score of 16, where higher scores indicate better balance performance.

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
其他
责任方
主要研究者
主要研究者

Lütfiye AKKURT, MSc

Assistant Professor

Kutahya Health Sciences University

研究点 (2)

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标识符

NCT 编号
NCT07847827
其他研究编号
2026/10-51

日期

首次提交
(7天前)
首次发布
(昨天)
主要完成日期
(7个月后)
研究完成日期
(8个月后)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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