The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults (SAFR)

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).

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Dysfunction; Falls; Gait Disorders; Fall Risk; Fall Risk Factors; Self-Awareness

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • University of Haifa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Medical diagnosis significantly affecting cognition, emotion, or ambulation
• Hospitalization within the past month
• Montreal Cognitive Assessment (MoCA) score below 20

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults; Adults aged 60-85 living in the community, ambulatory independently or with a cane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Clalit Health Services

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait; Older Adults; Executive Function; Cognitive Function; Falls; Fall Risk; Self-Awareness; Dual-Task Walking
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cognitive Dysfunction; Mobility Limitation
• Other Study ID Numbers: COM2-0046-22_076-25; COM2-0046-22 (Other Identifier: Helsinki Committee, Clalit Health Services)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No