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Balance Control in ElderlyNCT07878832

Turkish Adaptation of the Multidimensional Falls Efficacy Scale in Older Adults

An observational study of Balance Control in Elderly and Falls (Accidents) in Old Age, run by Gazi University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and older
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Oct 2026to 31 Dec 2027
How long will I take part?
7 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: The study population will consist of community-dwelling adults aged 65 years and older.

Who may be able to join

  • Adults aged 65 years and older.
  • Community-dwelling individuals living independently in the community.
  • Individuals able to move independently at home, with or without an assistive device.
  • Individuals who voluntarily agree to participate and provide informed consent.

Who cannot join

  • Individuals with a Standardized Mini-Mental State Examination (SMMSE) score of 23 or lower.
  • Individuals with neurological disorders that may significantly affect balance, mobility, or falls-related self-efficacy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yasemin APAYDIN, Research Assistant, PhD contact

+90 (464) 344 20 45

yasemin.apaydin@erdogan.edu.tr

Turkey (Türkiye)1 site
  • Guneysu Vocational School of Physical Therapy and Rehabilitation

    Rize, Guneysu

Other trials in Turkey (Türkiye)

About this study

Official title: Turkish Cultural Adaptation and Psychometric Evaluation of the Multidimensional Falls Efficacy Scale in Older Adults

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.

Read more

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.

Read the detailed description

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Falls Efficacy Scale-International (FES-I)

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.

Keywords
Patient Reported Outcome Measures, Self Efficacy, Multidimensional Falls Efficacy Scale, Falls, Older Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07878832
Study groupRoleWhat they receive
older adultsCommunity-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 7-10 days after baseline

Secondary outcomes (4)
  1. 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.

    Measured: Baseline

  2. 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).

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline and 7-10 days after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start19 Oct 2026 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07878832
Sponsor's protocol ID
2026/296
Status last verified
Sep 2026
First submitted
10 Oct 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Balance Control in Elderly and Falls (Accidents) in Old Age, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yasemin APAYDIN, Research Assistant, PhD (+90 (464) 344 20 45, yasemin.apaydin@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Internal Consistency and Test-Retest Reliability of the Turkish MdFES (time frame: Baseline and 7-10 days after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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