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临床试验/NCT07698444
NCT07698444已完成不适用

"Fear of Falling": i Determinanti Clinici e Psicologici Nel Paziente Neurologico. Studio Osservazionale di Tipo Trasversale

Universita di Verona1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Falls Efficacy Scale - International (FES-I)

研究概览

简要总结

Stroke survivors are at increased risk of falls and often develop Fear of Falling (FoF), which can negatively affect mobility, independence, participation in daily activities, and quality of life. FoF is common after stroke, but the factors that contribute to it may differ depending on the stage of recovery.

The purpose of this observational study is to investigate the prevalence of FoF in stroke survivors and to identify which motor, cognitive, and psychological factors are associated with it.

Adults with ischemic or hemorrhagic stroke who are able to walk, even with assistance, will undergo a clinical and neuropsychological assessment. Evaluations will include measures of fear of falling, balance, walking ability, functional independence, mood, anxiety, cognitive functioning, awareness of deficits, personality traits, and behavioral symptoms.

The findings of this study may help clinicians better understand the mechanisms underlying fear of falling after stroke and support the development of more personalized assessment and rehabilitation strategies tailored to different stages of recovery.

详细描述

Stroke survivors experience a substantially higher risk of falls than the general population, and this risk may persist for many years after the cerebrovascular event. Beyond the physical consequences of falls, many individuals develop a fear of falling (FOF), a condition characterized by concerns about falling during everyday activities. Fear of falling is highly prevalent after stroke and has been associated with reduced mobility, activity restriction, decreased participation in social and community life, poorer quality of life, and increased risk of future falls.

Traditionally, fear of falling has been considered a direct consequence of previous falls or physical impairment. However, contemporary theoretical models suggest that FOF is a multidimensional phenomenon influenced by the interaction of motor, cognitive, emotional, and behavioral factors. Studies conducted in community-dwelling older adults have shown that individuals may present different profiles of fear of falling depending not only on their physical abilities but also on psychological characteristics such as anxiety, self-efficacy, and risk perception. Similar mechanisms may be relevant in stroke populations, where motor deficits often coexist with cognitive impairment, emotional disturbances, and reduced awareness of deficits.

Previous research in stroke has primarily focused on isolated determinants of fear of falling, including balance impairment, reduced walking ability, history of falls, and use of walking aids. While these factors have consistently demonstrated associations with FOF, emerging evidence suggests that psychological variables, such as anxiety and depression, as well as cognitive functions, may also contribute substantially to the development and maintenance of fear of falling. Nevertheless, the relative contribution of motor, cognitive, and psychological factors remains insufficiently understood.

An additional limitation of the current literature is that stroke recovery is often treated as a homogeneous condition. Recovery after stroke is a dynamic process characterized by substantial changes over time. During the subacute phase, functional outcomes are strongly influenced by neurological recovery and motor impairment. In contrast, during the chronic phase, motor recovery often reaches a plateau, while cognitive and psychological factors may become increasingly important determinants of participation and perceived disability. Consequently, the factors associated with fear of falling may differ according to stroke chronicity.

The present observational study was designed to investigate fear of falling in individuals with ischemic or hemorrhagic stroke across different stages of recovery. A comprehensive multidimensional assessment was conducted, including clinical, motor, cognitive, emotional, behavioral, and awareness-related domains. By examining a broad range of factors simultaneously, the study aims to provide a more integrated understanding of the mechanisms underlying fear of falling after stroke.

研究设计

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

入排标准

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

入选标准

  • signed informed consent
  • age greater than 18 years
  • diagnosis of ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
  • ability to walk, even with difficulty, with a Functional Ambulation Classification (FAC) score ≥ 1 (Holden et al., 1984)

排除标准

  • concomitant presence of two or more of neurological diseases
  • history of cognitive impairment
  • history of intellectual disability
  • severe language/comprehension deficits as assessed by the NIH Stroke Scale (NIHSS) (Brott et al., 1989)
  • history of psychiatric disorders without pharmacological compensation
  • non-neurological conditions (e.g., orthopedic problems) that affect deambulation
  • patients with acute medical conditions requiring emergency care.

研究组 & 干预措施

Stroke Patients

Participants with ischemic or haemorrhagic stroke referred to the Neurorehabilitation Unit of the University Hospital of Verona were included in the study. They were recruited from June 2021 to September 2023. The inclusion criteria were: signed informed consent; age greater than 18 years; diagnosis of ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT); ability to walk, even with difficulty, with a Functional Ambulation Classification (FAC) score ≥ 1. Exclusion criteria were: concomitant presence of two or more of neurological diseases; history of cognitive impairment; history of intellectual disability; severe language/comprehension deficits as assessed by the NIH Stroke Scale (NIHSS); history of psychiatric disorders without pharmacological compensation; and non-neurological conditions (e.g., orthopedic problems) that affect deambulation; patients with acute medical conditions.

干预措施: Clinical and neuropsychological evaluation (Diagnostic Test)

结局指标

主要结局

Falls Efficacy Scale - International (FES-I)

时间窗: Baseline

Fear of falling was assessed using the Falls Efficacy Scale - International (FES-I), a self-report questionnaire evaluating concern about falling during daily activities. The scale consists of 16 items rated on a 4-point Likert scale (1 = not at all concerned to 4 = very concerned), with total scores ranging from 16 to 64; higher scores indicate greater fear of falling (Kempen et al., 2008). For categorical analyses, scores of 16-19 were classified as absent/low fear of falling, whereas scores ≥20 indicated moderate-to-high fear of falling (Delbaere, Close, Mikolaizak, et al., 2010).

次要结局

  • National Institutes of Health Stroke Scale (NIHSS)(Baseline)
  • Barthel Index (BI)(Baseline)
  • Berg Balance Scale (BBS)(Baseline)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline)
  • Brief Social Phobia Scale (BSPS)(Baseline)
  • Big Five Inventory - 10 item (BFI-10)(Baseline)
  • Trail Making Test (TMT-A and TMT-B)(Baseline)
  • Go/No-Go task(Baseline)
  • Patient Competency Rating Scale (PCRS)(Baseline)
  • Test for Anosognosia - Motor (VATA-M).(Baseline)
  • Neuropsychiatric Inventory (NPI)(Baseline)
  • Toronto Alexithymia Scale (TAS-20)(Baseline)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Varalta

Researcher

Universita di Verona

研究点 (1)

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