FallsSAFRNCT07367763
The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults
An observational study of Falls and Fall Risk, run by University of Haifa at 1 site in Israel.
Trial summary
This study examines the relationship between self-awareness and the risk of falls during walking in older adults and rehabilitation patients. Falls are a major health concern among older adults worldwide. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls, Fall Risk, Fall Risk Factors
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling older adults and patients attending a rehabilitation day center, all aged 60-85 years, who are ambulatory independently or with a cane and able to complete cognitive and awareness assessments.
Who may be able to join
- Adults aged 60-85 years
- Men and women
- Ambulatory independently or with a cane
- Hebrew or Arabic speakers, able to read and write
- Living with a spouse or caregiver who can provide informant questionnaire data
Who cannot join
- Medical diagnosis significantly affecting cognition, emotion, or ambulation
- Hospitalization within the past month
- Montreal Cognitive Assessment (MoCA) score below 20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults From Rehabilitation Settings and the Community
This study examines the relationship between self-awareness and the risk of falls during walking in older adults and rehabilitation patients. Falls are a major health concern among older adults worldwide. Many studies have shown that executive functions, such as attention and problem-solving, are related to fall risk; however, little is known about the role of self-awareness-the ability to recognize one's own strengths, limitations, and errors-in predicting falls.
In this study, approximately 100 participants (adults aged 60-85 years) will be recruited from both a rehabilitation day center and community settings. Participants will complete cognitive tests, self-awareness questionnaires, and walking assessments using wearable sensors. Walking will be tested both at a normal pace and while performing a secondary task (dual-task walking).
Read more
The results will help clarify whether reduced self-awareness is an independent risk factor for falls. Findings may improve fall-prevention strategies in both rehabilitation and community settings.
The study protocol has been reviewed and approved by the Faculty Ethics Committee, University of Haifa, and the Helsinki Committee of Clalit Health Services.
Read the detailed description
Falls are among the most common health issues in older adults, with 30-40% of individuals aged 65 and older experiencing at least one fall each year. Falls are strongly associated with reduced quality of life, increased healthcare costs, and higher mortality rates. Executive dysfunction has consistently been identified as a major predictor of fall risk. Yet impaired self-awareness-defined as the ability to accurately evaluate one's own abilities, limitations, and errors-has rarely been studied as an independent risk factor.
The present study is designed to examine whether reduced self-awareness contributes uniquely to fall risk in adults. It combines two cohorts under one protocol: (1) patients recruited from a day rehabilitation center, and (2) community-dwelling older adults. All particpants will undergo identical assessments.
Study outcome measures
- Montreal Cognitive Assessment (MoCA) for global cognition (also a screening test for cognitive decline)
- NeuroTrax™ computerized executive function and attention tests
- Phonemic Verbal Fluency (PVF) task
- Patient Competency Rating Scale (PCRS) and task-specific awareness questionnaires
- Gait analysis using APDM Mobility Lab™ sensors under single-task (normal walking) and dual-task (walking + PVF) conditions
This observational, cross-sectional study will recruit approximately 100 participants (from rehabilitation and from the community). Inclusion criteria: age 60-85 years, Hebrew or Arabic speakers, ambulatory independently or with a cane, and living with a spouse or caregiver who can provide informant data. Exclusion criteria: medical diagnoses significantly affecting cognition or ambulation, hospitalization within the last month, and MoCA score below 20.
The findings are expected to expand the understanding of fall risk factors by highlighting the role of self-awareness. Results may inform future interventions and clinical guidelines for fall prevention in both clinical and community populations.
- Conditions
- Falls, Fall Risk, Fall Risk Factors, Cognitive Dysfunction, Self-Awareness, Gait Disorders
- Keywords
- Self-Awareness, Falls, Fall Risk, Dual-Task Walking, Executive Function, Gait, Older Adults, Rehabilitation, Cognitive Function
- Medical subject headings
- Cognitive Dysfunction, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults | Adults aged 60-85 living in the community, ambulatory independently or with a cane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Competency Rating Scale (PCRS-2) Discrepancy Score
Self-awareness will be assessed using the Patient Competency Rating Scale (PCRS-2), which includes both self-report and proxy-report forms. The outcome measure will be the discrepancy score between patient and caregiver ratings, reflecting the participant's level of awareness across cognitive, emotional, social, and functional domains.
Measured: baseline
Gait Speed and Variability
Gait performance will be objectively measured using APDM Mobility Lab sensors. Primary gait parameters include walking speed (m/s) and step-to-step variability (%). Dual-task cost will be calculated as the relative change in gait parameters between single-task and dual-task walking, serving as indicators of gait stability and fall risk.
Measured: baseline
Secondary outcomes (1)
Self-Awareness Walking Questionnaire Score
Participants will complete a short questionnaire rating their perceived walking stability and safety under single-task (normal walking) and dual-task (walking while performing a cognitive task) conditions. The outcome measure will be the mean score across items, reflecting task-specific self-awareness.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Principal investigator, Galit Yogev-Seligmann, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367763
- Sponsor's protocol ID
- COM2-0046-22_076-25
- Other IDs
- COM2-0046-22
- Acronym
- SAFR
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet certain whether individual participant data (IPD) will be shared. The decision will depend on future publication requirements, institutional guidelines, and participant privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults From Rehabilitation Settings and the Community
- ClinicalTrials.gov ID
- NCT07367763
- Acronym / sponsor ID
- SAFR / COM2-0046-22_076-25
- Conditions
- Falls, Fall Risk, Fall Risk Factors, Cognitive Dysfunction, Self-Awareness, Gait Disorders
- Keywords
- Self-Awareness, Falls, Fall Risk, Dual-Task Walking, Executive Function, Gait, Older Adults, Rehabilitation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 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.
This study examines the relationship between self-awareness and the risk of falls during walking in older adults and rehabilitation patients. Falls are a major health concern among older adults worldwide. Many studies have shown that executive functions, such as attention and problem-solving, are related to fall risk; however, little is known about the role of self-awareness-the ability to recognize one's own strengths, limitations, and errors-in predicting falls.
In this study, approximately 100 participants (adults aged 60-85 years) will be recruited from both a rehabilitation day center and community settings. Participants will complete cognitive tests, self-awareness questionnaires, and walking assessments using wearable sensors. Walking will be tested both at a normal pace and while performing a secondary task (dual-task walking).
The results will help clarify whether reduced self-awareness is an independent risk factor for falls. Findings may improve fall-prevention strategies in both rehabilitation and community settings.
The study protocol has been reviewed and approved by the Faculty Ethics Committee, University of Haifa, and the Helsinki Committee of Clalit Health Services.
Detailed description
Falls are among the most common health issues in older adults, with 30-40% of individuals aged 65 and older experiencing at least one fall each year. Falls are strongly associated with reduced quality of life, increased healthcare costs, and higher mortality rates. Executive dysfunction has consistently been identified as a major predictor of fall risk. Yet impaired self-awareness-defined as the ability to accurately evaluate one's own abilities, limitations, and errors-has rarely been studied as an independent risk factor.
The present study is designed to examine whether reduced self-awareness contributes uniquely to fall risk in adults. It combines two cohorts under one protocol: (1) patients recruited from a day rehabilitation center, and (2) community-dwelling older adults. All particpants will undergo identical assessments.
Study outcome measures
- Montreal Cognitive Assessment (MoCA) for global cognition (also a screening test for cognitive decline)
- NeuroTrax™ computerized executive function and attention tests
- Phonemic Verbal Fluency (PVF) task
- Patient Competency Rating Scale (PCRS) and task-specific awareness questionnaires
- Gait analysis using APDM Mobility Lab™ sensors under single-task (normal walking) and dual-task (walking + PVF) conditions
This observational, cross-sectional study will recruit approximately 100 participants (from rehabilitation and from the community). Inclusion criteria: age 60-85 years, Hebrew or Arabic speakers, ambulatory independently or with a cane, and living with a spouse or caregiver who can provide informant data. Exclusion criteria: medical diagnoses significantly affecting cognition or ambulation, hospitalization within the last month, and MoCA score below 20.
The findings are expected to expand the understanding of fall risk factors by highlighting the role of self-awareness. Results may inform future interventions and clinical guidelines for fall prevention in both clinical and community populations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Adults aged 60-85 living in the community, ambulatory independently or with a cane |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older adults and patients attending a rehabilitation day center, all aged 60-85 years, who are ambulatory independently or with a cane and able to complete cognitive and awareness assessments.
Key inclusion criteria (5 listed)
- Adults aged 60-85 years
- Men and women
- Ambulatory independently or with a cane
- Hebrew or Arabic speakers, able to read and write
- Living with a spouse or caregiver who can provide informant questionnaire data
Key exclusion criteria (3 listed)
- Medical diagnosis significantly affecting cognition, emotion, or ambulation
- Hospitalization within the past month
- Montreal Cognitive Assessment (MoCA) score below 20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Competency Rating Scale (PCRS-2) Discrepancy Score
Time frame: baseline
Self-awareness will be assessed using the Patient Competency Rating Scale (PCRS-2), which includes both self-report and proxy-report forms. The outcome measure will be the discrepancy score between patient and caregiver ratings, reflecting the participant's level of awareness across cognitive, emotional, social, and functional domains.
Gait Speed and Variability
Time frame: baseline
Gait performance will be objectively measured using APDM Mobility Lab sensors. Primary gait parameters include walking speed (m/s) and step-to-step variability (%). Dual-task cost will be calculated as the relative change in gait parameters between single-task and dual-task walking, serving as indicators of gait stability and fall risk.
1 secondary outcome
Self-Awareness Walking Questionnaire Score
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. It is not yet certain whether individual participant data (IPD) will be shared. The decision will depend on future publication requirements, institutional guidelines, and participant privacy considerations.
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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 Falls and Fall Risk, run by University of Haifa at 1 site in Israel.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Competency Rating Scale (PCRS-2) Discrepancy Score (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.