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临床试验/NCT04688060
NCT04688060已完成不适用

Assosiations Between Fear of Fall, Functional Ambulation Category and Quality of Life in Stroke Survivors

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年11月1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
146
试验地点
1
主要终点
Falls Efficacy Scale-International (FES-I)

研究概览

简要总结

Stroke is one of the most common causes of acquired adult disability. The stroke survivors have lots of mobility difficulties such as poor standing, decreased walking speed, balance disturbances, and increased risk of falls (1).

Falling is a major threat to stroke patients for physical injury. Fracture resulting from falling, could affect the rehabilitation potential and functional recovery (2,3).

After a stroke, falls are one of the most common medical complications with a 73% incidence within the six months (4). In addition to physical components, psychological factors related falling include fear of falling(5). Fear of falling is defined as persisting concern regarding falling and associated with many negative physical and psychological factors (6,7). It not only affects a simple health concern, but also avoidance of activities and a loss of confidence (8).

To determine the associating factors of fear of falling (FOF) and the correlations between FOF, functional ambulation category (FAC) and quality of life (QOL) on stroke patients.

详细描述

This study was a cross-sectional observational study. Each participant was assessed with standardized questionnaires and examined. Eighty six hemiplegic cronic stroke patients were recruited from our clinic from March 2018 to December 2020 with informed consent. We divided the participants into two groups; with fallers and non-fallers.

The inclusion criteria were stroke duration of 6 months or more follow 3-step commands, were able to walk 10m with no physical assistance with or without any assistive device, and scoring ≥3 on Functional Ambulation Category, and physically able to complete the testing procedure.

Exclusion criteria were other neurologic diagnosesor were medically unstable, lower-extremity fracture, or other surgical procedures during the last 6 months and were unable to provide consent.

All participants signed a written consent prior to participation in the study. The study was approved by the local institutional review board. The study was conducted in accordance with the Declaration of Helsinki ethical principles for human experimentation.

Demographic characteristics and medical history recorded by questionnaire included age, height, weight, comorbidities, number of medications, use of assistive device, date of stroke onset, and side of stroke, hemorrhagic or ischemic.

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

入选标准

  • stroke duration of 6 months or more
  • follow 3-step commands
  • were able to walk 10m with no physical assistance with or without any assistive device,
  • scoring ≥3 on Functional Ambulation Category,
  • physically able to complete the testing procedure.

排除标准

  • other neurologic diagnosesor were medically unstable,
  • lower-extremity fracture,
  • other surgical procedures during the last 6 months
  • were unable to provide consent.

结局指标

主要结局

Falls Efficacy Scale-International (FES-I)

时间窗: basline

assess the fear of falling level of participants about falling during indoor or outdoor activities minumum score 16 maximum score 64 low, moderate, and high concern (16-19, 20-27, and 28-64)

次要结局

未报告次要终点

研究者

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

Tugba Sahbaz

specialist doctor of physical medicine and rehabilitation

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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