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

NCT07698444 | Completed DMC

• 1 other identifier: FOF_PSS
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Fear of Falling; FoF; Cognitive functions; Motor functions

Outcome Measures

Primary Outcomes (1)

• Falls Efficacy Scale - International (FES-I)

  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

Secondary Outcomes (12)

• 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

Study Arms (1)

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.

Diagnostic Test: Clinical and neuropsychological evaluation

Interventions

Clinical and neuropsychological evaluation DIAGNOSTIC_TEST

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.

Stroke Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Ospedale Borgo Roma

Verona, Verona, 37134, Italy

Location

Related Publications (1)

• Pin TW, Winser SJ, Chan WLS, Chau B, Ng S, Wong T, Mak M, Pang M. Association between fear of falling and falls following acute and chronic stroke: a systematic review with meta-analysis. J Rehabil Med. 2024 Jan 16;56:jrm18650. doi: 10.2340/jrm.v56.18650.

  PMID: 38226564 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 13, 2026
• Study Start: June 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 13, 2026

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)