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Fear of Falling: Clinical and Psychological Determinants in Neurological Patients. A Cross-Sectional Observational Study.

7. Juli 2026 aktualisiert von: Valentina Varalta, Universita di Verona

"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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

106

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Italien
    • Verona
      • Verona, Verona, Italien, 37134
        • Ospedale Borgo Roma

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Cohort of participants with a diagnosis of stroke (ischemic or hemorrhagic) admitted to the Neurorehabilitation Unit (UOC) either as inpatients or outpatients.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Diagnosetest: Clinical and neuropsychological evaluation

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Falls Efficacy Scale - International (FES-I)
Zeitfenster: 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).
Baseline

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universita di Verona

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2021

Primärer Abschluss (Tatsächlich)

30. September 2023

Studienabschluss (Tatsächlich)

30. September 2023

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2026

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FOF_PSS

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data collected during this study will not be made publicly available due to privacy and confidentiality considerations and because no data-sharing plan has been established.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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