StrokeNCT07698444
Fear of Falling: Clinical and Psychological Determinants in Neurological Patients. A Cross-Sectional Observational Study.
An observational study of Stroke, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Clinical and neuropsychological evaluation
- How many people
- 106 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 30 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of participants with a diagnosis of stroke (ischemic or hemorrhagic) admitted to the Neurorehabilitation Unit (UOC) either as inpatients or outpatients.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Clinical and neuropsychological evaluation
- Keywords
- Stroke, Fear of Falling, FoF, Cognitive functions, Motor functions
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and neuropsychological evaluationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Clinical and neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (12)
National Institutes of Health Stroke Scale (NIHSS)
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).
Measured: Baseline
Barthel Index (BI)
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).
Measured: Baseline
Berg Balance Scale (BBS)
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).
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)
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).
Measured: Baseline
Brief Social Phobia Scale (BSPS)
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).
Measured: Baseline
Big Five Inventory - 10 item (BFI-10)
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).
Measured: Baseline
Trail Making Test (TMT-A and TMT-B)
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).
Measured: Baseline
Go/No-Go task
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).
Measured: Baseline
Patient Competency Rating Scale (PCRS)
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).
Measured: Baseline
Test for Anosognosia - Motor (VATA-M).
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).
Measured: Baseline
Neuropsychiatric Inventory (NPI)
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).
Measured: Baseline
Toronto Alexithymia Scale (TAS-20)
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jun 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698444
- Sponsor's protocol ID
- FOF_PSS
- Status last verified
- Apr 2021
- First submitted
- 29 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38226564
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Fear of Falling": i Determinanti Clinici e Psicologici Nel Paziente Neurologico. Studio Osservazionale di Tipo Trasversale
- ClinicalTrials.gov ID
- NCT07698444
- Acronym / sponsor ID
- FOF_PSS
- Conditions
- Stroke
- Keywords
- Stroke, Fear of Falling, FoF, Cognitive functions, Motor functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients | – | Diagnostic Test: Clinical and neuropsychological evaluationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of participants with a diagnosis of stroke (ischemic or hemorrhagic) admitted to the Neurorehabilitation Unit (UOC) either as inpatients or outpatients.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and neuropsychological evaluationParticipants 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. | Diagnostic test | Stroke Patients |
Primary outcome
Falls Efficacy Scale - International (FES-I)
Time frame: 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).
12 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Baseline
Barthel Index (BI)
Time frame: Baseline
Berg Balance Scale (BBS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Brief Social Phobia Scale (BSPS)
Time frame: Baseline
Big Five Inventory - 10 item (BFI-10)
Time frame: Baseline
Trail Making Test (TMT-A and TMT-B)
Time frame: Baseline
Go/No-Go task
Time frame: Baseline
Patient Competency Rating Scale (PCRS)
Time frame: Baseline
Test for Anosognosia - Motor (VATA-M).
Time frame: Baseline
Neuropsychiatric Inventory (NPI)
Time frame: Baseline
Toronto Alexithymia Scale (TAS-20)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 38226564Pin 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Efficacy Scale - International (FES-I) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.