跳至主要内容
临床试验/NCT07367763
NCT07367763进行中(未招募)不适用

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

University of Haifa1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Patient Competency Rating Scale (PCRS-2) Discrepancy Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Adults

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

结局指标

主要结局

Patient Competency Rating Scale (PCRS-2) Discrepancy Score

时间窗: 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

时间窗: 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.

次要结局

  • Self-Awareness Walking Questionnaire Score(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Galit Yogev-Seligmann

Senior Lecturer, Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa

University of Haifa

研究点 (1)

Loading locations...

相似试验

The Relationship Between Self-Awareness and Risk of... | 临床试验