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

NCT07367763 | Active Not Recruiting

• 2 other identifiers: COM2-0046-22_076-25COM2-0046-22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fall Risk; Fall Risk Factors; Self-Awareness; Gait Disorders; Falls; Cognitive Dysfunction

Keywords

Self-Awareness; Falls; Fall Risk; Dual-Task Walking; Executive Function; Gait; Older Adults; Rehabilitation; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Self-Awareness Walking Questionnaire Score

  baseline

Study Arms (1)

Adults

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

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clalit Health Services: collaborator
• University of Haifa: lead

Study Sites (1)

University of Haifa

Haifa, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Mobility Limitation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: January 26, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

IL (1)