Fear of Falling: Clinical and Psychological Determinants in Neurological Patients. A Cross-Sectional Observational Study.
"Fear of Falling": i Determinanti Clinici e Psicologici Nel Paziente Neurologico. Studio Osservazionale di Tipo Trasversale
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
The primary objective of the study is to evaluate the prevalence of fear of falling in stroke survivors and to identify the factors associated with its presence and severity. A secondary objective is to explore whether the determinants of fear of falling differ between individuals in the subacute and chronic phases of stroke recovery. Particular attention is devoted to understanding the relative contribution of motor functioning, cognitive performance, anxiety, depression, behavioral symptoms, personality traits, and awareness of deficits.
Improving the understanding of fear of falling after stroke may have important clinical implications. Identification of stage-specific determinants could support more accurate clinical characterization of patients and facilitate the development of targeted rehabilitation strategies. In particular, the findings may help clinicians determine whether interventions should primarily focus on motor recovery or whether cognitive and psychological factors should also be addressed to reduce fear of falling and its impact on daily functioning and participation.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Verona
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Verona, Verona, Италия, 37134
- Ospedale Borgo Roma
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
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Participants were recruited during a physiatric consultation and underwent a clinical and neuropsychological evaluation. The assessment protocol, administered by a physiatrist and a neuropsychologist, lasted approximately 15 minutes for the physiatric evaluation and 25 minutes for the neuropsychological assessment. Physiatric assessment The physiatric evaluation included the collection of demographic and clinical data, with assessment of neurological severity, disability, motor functioning, and fear of falling. Cognitive and psychological assessment Cognitive and psychological domains were evaluated by a neuropsychologist and included assessment of mood, anxiety, personality traits, cognitive functioning, behavioral disturbances, and awareness of deficits. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Falls Efficacy Scale - International (FES-I)
Временное ограничение: Baseline
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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). |
Baseline
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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National Institutes of Health Stroke Scale (NIHSS)
Временное ограничение: Baseline
|
Neurological severity was assessed using the National Institutes of Health Stroke Scale (NIHSS), a 0-42 scale in which higher scores indicate greater neurological impairment.
Standard severity classifications are: 0 (no deficit), 1-4 (mild), 5-15 (moderate), 16-20 (moderate-to-severe), and 21-42 (severe) (Brott et al., 1989).
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Baseline
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Barthel Index (BI)
Временное ограничение: Baseline
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Functional independence in activities of daily living was measured using the Barthel Index (BI), an ordinal scale ranging from 0 to 100, with higher scores indicating greater independence (Mahoney & Barthel, 1965).
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Baseline
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Berg Balance Scale (BBS)
Временное ограничение: Baseline
|
Motor functioning was further evaluated through retrospective self-report of falls over the past 6 and 12 months, balance using the Berg Balance Scale (BBS; 0-56, higher scores indicate better balance) (Berg et al., 1989), and walking ability using the Functional Ambulation Classification (FAC; 0-5, higher scores indicate greater independence) (Holden et al., 1984).
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Baseline
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Hospital Anxiety and Depression Scale (HADS)
Временное ограничение: Baseline
|
Depressive and anxiety symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire composed of two subscales (anxiety and depression), each ranging from 0 to 21 with higher scores indicating greater levels of anxiety and depression (Zigmond & Snaith, 1983).
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Baseline
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|
Brief Social Phobia Scale (BSPS)
Временное ограничение: Baseline
|
Social anxiety was measured using the Brief Social Phobia Scale (BSPS), a 17-item clinician-rated scale assessing fear, avoidance, and physiological symptoms.
Each item is rated from 0 to 4, with total scores ranging from 0 to 68; higher scores indicate greater severity of social anxiety symptoms (Davidson et al., 1997).
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Baseline
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Big Five Inventory - 10 item (BFI-10)
Временное ограничение: Baseline
|
Personality traits were assessed using the Big Five Inventory - 10 item (BFI-10), a 10-item self-report questionnaire measuring five personality dimensions (openness, conscientiousness, extraversion, agreeableness, and neuroticism).
Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with higher scores indicating greater expression of each trait (Rammstedt & John, 2007).
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Baseline
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Trail Making Test (TMT-A and TMT-B)
Временное ограничение: Baseline
|
Processing speed, visual scanning, and cognitive flexibility were assessed using the Trail Making Test (TMT-A and TMT-B).
Performance is recorded as completion time (in seconds), with longer times indicating worse cognitive performance (Siciliano et al., 2019).
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Baseline
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Go/No-Go task
Временное ограничение: Baseline
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Inhibitory control was assessed using a Go/No-Go task, a well-established experimental paradigm commonly used in neuropsychological assessment.
Performance was indexed by accuracy (hits and commission errors) and reaction times, with higher commission errors indicating poorer inhibitory control (Siciliano et al., 2019).
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Baseline
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Patient Competency Rating Scale (PCRS)
Временное ограничение: Baseline
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Awareness of deficits was evaluated using the Patient Competency Rating Scale (PCRS).
The PCRS is a self- and informant-report questionnaire assessing awareness of cognitive and functional abilities across daily activities.
It consists of 30 items rated on a 5-point scale (1 = cannot do it at all, 5 = can do it with ease), with lower self-informant discrepancy scores indicating greater awareness and higher discrepancy reflecting reduced insight (Prigatano et al., 1986).
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Baseline
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Test for Anosognosia - Motor (VATA-M).
Временное ограничение: Baseline
|
The VATA-M is a scale assessing awareness of motor deficits in the upper and lower limbs, with higher discrepancy scores between perceived and actual performance indicating greater anosognosia for motor impairment (Fotopoulou et al., 2010).
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Baseline
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Neuropsychiatric Inventory (NPI)
Временное ограничение: Baseline
|
Behavioral disturbances were assessed using the Neuropsychiatric Inventory (NPI), a clinician-rated instrument evaluating a range of neuropsychiatric symptoms including agitation, depression, anxiety, irritability, and apathy.
The NPI assesses both frequency (1-4) and severity (1-3) of symptoms, with a composite score ranging from 0 to 144; higher scores indicate greater neuropsychiatric burden (Cummings et al., 1994).
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Baseline
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Toronto Alexithymia Scale (TAS-20)
Временное ограничение: Baseline
|
Alexithymia was measured using the Toronto Alexithymia Scale (TAS-20), a 20-item self-report questionnaire assessing difficulty in identifying and describing feelings and externally oriented thinking.
Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with total scores ranging from 20 to 100; higher scores indicate greater levels of alexithymia (Bagby et al., 1994).
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Baseline
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FOF_PSS
Планирование данных отдельных участников (IPD)
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