An observational study in Balance Control in Elderly, Falls (Accidents) in Old Age and Older Adults (65 Years and Older), sponsored by Gazi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Gazi University · Observational
Falls are a major health concern among older adults and can lead to injuries, reduced independence, and a lower quality of life. In addition to physical changes associated with aging, an individual's confidence in preventing falls, maintaining balance, and managing situations during and after a fall may influence daily activities and social participation.
The Multidimensional Falls Efficacy Scale (MdFES) is a questionnaire designed to assess older adults' confidence in performing everyday activities without falling. It includes activities related to both daily living and participation in the community. A culturally adapted and reliable Turkish version of this questionnaire is needed to assess fall-related self-efficacy in Turkish-speaking older adults.
The aim of this study is to adapt the MdFES into Turkish and evaluate its validity, reliability, and other measurement properties in older adults. The study will examine whether the Turkish version measures fall-related self-efficacy appropriately and provides consistent results.
The findings may provide researchers and healthcare professionals with a useful assessment tool for evaluating fall-related self-efficacy in older adults. This may support the identification of individuals who lack confidence in performing daily activities and contribute to research and clinical approaches aimed at improving confidence, independence, and participation in everyday life.
Background and Rationale
Falls and fall-related concerns are important health issues among older adults. Age-related changes in muscle strength, balance, gait, sensory function, and reaction time may increase the risk of falling and affect an individual's ability to perform daily activities independently. Falls may also lead to activity restriction, reduced social participation, and decreased quality of life.
Fall-related self-efficacy refers to an individual's perceived confidence in preventing and managing falls. It is conceptually distinct from fear of falling, which primarily reflects concern or apprehension about falling. Assessing fall-related self-efficacy may provide complementary information about older adults' perceived ability to manage fall-related situations and maintain independence.
The Multidimensional Falls Efficacy Scale (MdFES) is a brief questionnaire developed to assess confidence in preventing and managing falls. A culturally adapted Turkish version with established measurement properties is needed for its appropriate use in Turkish-speaking older adults.
Study Objectives
The primary objective is to translate and culturally adapt the MdFES into Turkish and evaluate its validity and reliability in community-dwelling adults aged 65 years and older.
The specific objectives are to assess linguistic and cultural equivalence, content validity, factor structure, convergent and discriminant validity, internal consistency, test-retest reliability, and measurement error.
Study Design and Setting
This methodological study will use a cross-sectional design to assess validity and internal consistency, together with a test-retest component to evaluate reliability. The study will be conducted at Recep Tayyip Erdoğan University, Güneysu School of Physical Therapy and Rehabilitation, Türkiye.
The planned main sample consists of 150 participants. This total includes the 40 participants who will undergo test-retest assessment. These participants will complete the MdFES again 7-10 days after the initial assessment and will not be recruited separately.
Participants
The study will include community-dwelling adults aged 65 years and older who can move independently at home, with or without an assistive device, and who voluntarily agree to participate.
Individuals with a Standardized Mini-Mental State Examination score of 23 or below and those with neurological disorders considered likely to affect fall-related self-efficacy will be excluded.
Written informed consent will be obtained from all participants before data collection.
Translation and Cross-Cultural Adaptation
The Turkish adaptation will follow the cross-cultural adaptation guidelines proposed by Beaton and colleagues.
Two independent translators whose native language is Turkish and who are proficient in English will translate the original questionnaire into Turkish. Their translations will be compared and reconciled into a single preliminary version.
The preliminary version will be reviewed for clarity and comprehensibility. Two independent translators whose native language is English and who are unfamiliar with the original questionnaire will then back-translate the reconciled Turkish version into English.
The back-translated version will be compared with the original questionnaire to assess conceptual and linguistic equivalence. Feedback from the scale developer will be considered where applicable.
An expert committee with relevant expertise in physiotherapy, rehabilitation, and measurement will evaluate linguistic, cultural, and conceptual equivalence. Content validity will be examined using the Content Validity Index (CVI) and Content Validity Ratio (CVR).
The preliminary Turkish version will be pilot-tested in 20 older adults to assess item comprehensibility and feasibility. Any necessary revisions will be made before the main psychometric assessment. Pilot participants' data will not be included in the main psychometric analyses.
Study Procedures and Measures
Data will be collected through face-to-face assessments in a standardized and quiet setting. Participants will complete a demographic questionnaire and the following instruments.
Demographic Information Form
A researcher-developed form will record age, sex, height, weight, body mass index, educational level, use of assistive devices, and history of falls during the previous 6 and 12 months.
Multidimensional Falls Efficacy Scale (MdFES)
The MdFES consists of four items, each representing a distinct domain of falls efficacy: balance confidence (Item 1), balance recovery confidence (Item 2), safe landing confidence (Item 3), and post-fall recovery confidence (Item 4). Each item is scored from 0 to 4, yielding a total score ranging from 0 to 16, with higher scores indicating greater falls efficacy. The combined scores of Items 1 and 2 (range: 0-8) reflect perceived ability to prevent a fall or perceived balance control, whereas the combined scores of Items 3 and 4 (range: 0-8) reflect confidence in managing a fall.
Balance Recovery Confidence Scale (BRC)
The BRC assesses confidence in recovering balance following balance disturbances. It consists of 19 items, each scored from 0 to 10, with a total score ranging from 0 to 190. Higher scores indicate greater balance recovery confidence.
Activities-specific Balance Confidence (ABC) Scale
The ABC Scale assesses confidence in maintaining balance during everyday activities. It consists of 16 items scored from 0% to 100%. The mean score will be calculated, with higher scores indicating greater balance confidence.
The FES-I assesses concerns about falling during daily activities. It consists of 16 items scored from 1 to 4, with a total score ranging from 16 to 64. Higher scores indicate greater concern about falling.
All assessments will be administered using standardized instructions. Rest periods will be provided when needed. Of the 150 participants, 40 will complete the MdFES a second time 7-10 days after the initial assessment to evaluate test-retest reliability. These 40 participants are included in the total sample of 150.
No invasive procedures or additional laboratory tests will be performed.
Psychometric Evaluation
Content validity will be assessed using expert ratings, the CVI, and the CVR.
Confirmatory factor analysis (CFA) will be used to examine the factor structure of the Turkish MdFES in relation to the structure reported in the original validation study. Because the scale consists of four ordinal items, the suitability and identification of the proposed model will be evaluated before final model estimation. An estimator appropriate for ordinal data will be selected based on the model requirements and statistical consultation.
Model fit will be assessed using the chi-square-to-degrees-of-freedom ratio, Comparative Fit Index, Tucker-Lewis Index, Root Mean Square Error of Approximation, and Standardized Root Mean Square Residual, as appropriate.
Convergent validity will be examined by assessing associations between MdFES scores and BRC and ABC scores. Positive associations are expected. The relationship between MdFES and FES-I scores will also be examined, with a negative association expected because the scales assess related but conceptually distinct constructs.
Internal consistency will be evaluated using Cronbach's alpha and corrected item-total correlations. Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC), reported with 95% confidence intervals. The standard error of measurement (SEM) and minimal detectable change (MDC) will also be calculated.
Floor and ceiling effects will be assessed by calculating the proportions of participants obtaining the minimum and maximum possible total scores. Proportions exceeding 15% will be considered potential floor or ceiling effects.
Missing data will be examined before analysis, and appropriate handling methods will be selected according to the amount and pattern of missingness. The number of participants included in each analysis will be reported.
Statistical Analysis
Statistical analyses will be performed using IBM SPSS Statistics and appropriate software for confirmatory factor analysis, selected according to the specified model and estimator for ordinal data.
Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages.
Pearson or Spearman correlation coefficients will be used to examine associations between the MdFES and comparator instruments, depending on the characteristics of the data. Reliability and validity estimates will be reported with 95% confidence intervals where appropriate. All statistical tests will be two-sided, with statistical significance set at p \< 0.05.
Ethical Considerations and Data Protection
Ethical approval was obtained from the relevant non-interventional clinical research ethics committee before study procedures began (decision number: 2026/296). Permission to adapt and use the MdFES was obtained.
All participants will receive information about the study and provide written informed consent before participation. Participant data will be coded, identifying information will not be included in the analysis dataset, and access to study data will be restricted to the research team. Findings will be reported in aggregate without identifying individual participants.
Funding and Conflicts of Interest
The study has no external financial support. Research-related expenses will be covered by the investigator. The investigator declares no conflicts of interest.
Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.
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The study population will consist of community-dwelling adults aged 65 years and older.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Community-dwelling adults aged 65 years and older who can move independently at home, with or without an assistive device, and who provide informed consent. Participants will complete the Turkish Multidimensional Falls Efficacy Scale (MdFES) and other self-report measures to evaluate its validity. A subgroup of 40 participants will complete the MdFES again after 7-10 days to assess test-retest reliability. No intervention will be administered.
Internal Consistency and Test-Retest Reliability of the Turkish MdFES
Internal consistency will be evaluated using Cronbach's alpha. Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC) with a 95% confidence interval in a subgroup of 40 participants who will complete the Turkish MdFES twice, 7-10 days apart.
Time frame: Baseline and 7-10 days after baseline
Construct Validity of the Turkish MdFES
The construct validity of the Turkish MdFES will be evaluated using confirmatory factor analysis to assess the fit of the proposed factor structure. Model fit will be examined using appropriate fit indices, including the comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR), as appropriate.
Time frame: Baseline
Convergent Validity of the Turkish MdFES
Convergent validity will be assessed by examining correlations between Turkish MdFES scores and scores on the Activities-specific Balance Confidence (ABC) Scale and the Balance Recovery Confidence Scale (BRC).
Time frame: Baseline
Association Between Turkish MdFES Scores and Falls-Related Concerns
The association between Turkish MdFES scores and Falls Efficacy Scale-International (FES-I) scores will be examined using an appropriate correlation coefficient.
Time frame: Baseline
Measurement Error of the Turkish MdFES
The standard error of measurement (SEM) and minimal detectable change (MDC) will be calculated using test-retest reliability data.
Time frame: Baseline and 7-10 days after baseline
Plan to share: No — Individual participant data will not be shared publicly because of privacy and confidentiality considerations. Only aggregated results will be reported. Data will be handled in accordance with applicable data protection regulations and the approved research ethics protocol.
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