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Active, Not Recruiting

NCT Number: NCT07367763

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Falls Cognition Disorders Cognitive Dysfunction Fall Risk Fall Risk Factors Gait Disorders Mental Disorders Mobility Limitation Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Self-Awareness Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Haifa

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Self-Awareness Walking Questionnaire Score

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Clalit Health Services

Registry information

Official study title

The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults From Rehabilitation Settings and the Community

Acronym: SAFR

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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