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

U

University of Haifa

Status

Active, not recruiting

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT07367763
COM2-0046-22_076-25
COM2-0046-22 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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