Accidental FallsNCT06444061
The Balance Recovery Confidence (Brc) Scale
An observational study of Accidental Falls and Balance; Distorted, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational cross-sectional study is to evaluate the cultural adaptation, reliability, and validity of the Turkish version of the Balance Recovery Confidence Scale (BRCS), named Dengeyi Düzeltmede Kendine Güven Ölçeği (DDKGÖ), in older Turkish adults aged 65 and above. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Balance; Distorted, Aging
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2024to 6 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Study population: The study population will consist of community-dwelling older adults aged 65 years and older, recruited from a single center in Turkey. Participants must be literate in Turkish, capable of independent living (with or without walking aids), and able to perform basic mobility tasks such as walking 6 meters within 12 seconds. Exclusion criteria will include cognitive impairment (MMSE ≤23), mobility limitations (Timed Up and Go >12 seconds), recent fractures (within the last 6 months), severe cardiopulmonary or neurological conditions, and significant sensory impairments. Educational background, fall history, and sociodemographic characteristics will be documented to describe the sample.
Who may be able to join
- Age ≥65 years.
- Community-dwelling individuals capable of independent living (use of walking aids permitted).
- Literate in Turkish.
- Ability to complete 6 meters of walking within 12 seconds.
- Ability to grasp a 30 cm ruler with both hands.
Who cannot join
- Requiring assisted mobility outside the home.
- Mini-Mental State Examination (MMSE) score ≤23.
- Timed Up and Go (TUG) test duration >12 seconds.
- Active malignancy or history of myocardial infarction/cardiac surgery within the last 3 months.
- Structural heart disease, severe COPD, or oxygen dependence.
- Musculoskeletal/neurologic disorders affecting balance or muscle function (e.g., Parkinson's disease, stroke sequelae, multiple sclerosis, severe dementia, epilepsy).
Show all 9Show fewer
- Fracture within the last 6 months.
- Vision or hearing loss impairing assessment participation.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Adaptation and Psychometric Validation of the Balance Recovery Confidence Scale (BRCS) in Older Turkish Adults
The goal of this observational cross-sectional study is to evaluate the cultural adaptation, reliability, and validity of the Turkish version of the Balance Recovery Confidence Scale (BRCS), named Dengeyi Düzeltmede Kendine Güven Ölçeği (DDKGÖ), in older Turkish adults aged 65 and above. The main questions it aims to answer are:
Does the Turkish adaptation (DDKGÖ) demonstrate acceptable cultural validity, internal consistency, and test-retest reliability in measuring balance recovery confidence?
Read more
How does the DDKGÖ correlate with established tools assessing fear of falling, balance confidence, and physical performance (e.g., FES-I, ABC, TUG) to confirm convergent validity?
Participants will:
Complete the DDKGÖ questionnaire twice (7 days apart) to assess test-retest reliability.
Undergo physical performance tests (e.g., Timed Up and Go, Handgrip Strength Test, 30-Second Chair Stand Test).
Provide responses to additional self-report scales (FES-I, ABC) to evaluate convergent validity.
This study focuses on community-dwelling older adults without severe cognitive or physical impairments. Results will help standardize the DDKGÖ as a tool for identifying fall risk and personalizing rehabilitation strategies in Turkish geriatric populations.
Read the detailed description
This observational psychometric study is designed to establish the cultural validity, reliability, and overall measurement performance of the Turkish adaptation of the Balance Recovery Confidence Scale (DDKGÖ) in community-dwelling older adults. After obtaining informed consent and confirming basic eligibility, participants will undergo a two-phase assessment protocol with a one-week interval between phases.
During Phase 1, each participant will complete a structured interview and self-report questionnaires in a single session. These include the 19-item DDKGÖ (to assess reactive balance confidence), the Falls Efficacy Scale-International, and the Activities-specific Balance Confidence Scale. Trained assessors will also record demographic and health information (e.g., age, sex, comorbidities, history of falls) and administer a battery of standardized performance tests-such as the Timed Up and Go, 30-Second Chair Stand, Tinetti Balance \& Gait, and Handgrip Strength tests-to evaluate convergent validity.
Exactly seven days later, in Phase 2, participants will return to repeat the DDKGÖ under identical conditions to evaluate test-retest stability. All sessions will be conducted in the same clinical setting by the same examiners, using standardized instructions and order of administration to minimize procedural variability.
Collected data will be anonymized and entered into a secure database. Statistical analyses will include exploratory and confirmatory factor analyses to examine structural validity, calculation of internal consistency (e.g., Cronbach's α), intraclass correlation coefficients for test-retest reliability, Bland-Altman limits of agreement to quantify measurement error, and correlation analyses with existing balance- and fear-of-fall measures and performance tests to establish convergent validity.
By following this stepwise process-translation verification, initial validity and reliability testing, and retest assessment-this study will provide a comprehensive evaluation of whether the DDKGÖ is suitable for use in both research and clinical practice to identify older Turkish adults at elevated fall risk and to monitor changes in their confidence to recover from postural disturbances.
- Keywords
- Balance confidence, fall risk, cultural adaptation, geriatrics, psychometric properties
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Recovery Confidence Scale (BRCS)
The BRCS is a 19-item self-report scale developed to assess individuals' perception of self-efficacy for the restoration of balance after postural perturbations (such as stumbling, slipping, sudden loss of balance).
Measured: Start (initial assessment session, Day 1) and 7 days later (follow-up session on Day 8)
Secondary outcomes (6)
Falls Efficacy Scale-International ( FES-I )
The FES-I is a valid and reliable self-report scale consisting of 16 items designed to assess the subjective level of concern about the fear of falling during activities of daily living.
Measured: Baseline administration (Day 1)
Activities-specific Balance Confidence Scale ( ABC )
The ABC is a sixteen-item self-report tool that subjectively assesses individuals' confidence levels in maintaining balance during activities of daily living.
Measured: Baseline administration (Day 1)
Timed Up and Go ( TUG )
The TUG is a standardized clinical performance measurement protocol developed to measure the functional mobility capacity of individuals, assessing dynamic postural control, gait kinematics and movement strategies during activity transitions.
Measured: Baseline administration (Day 1)
Handgrip Strength Test ( HGST )
HGST is an objective neuromuscular assessment method used to quantitatively measure the maximal isometric contraction capacity of the hand and forearm muscles.
Measured: Baseline administration (Day 1)
Tinetti Balance & Gait Test ( TBT&TGT )
TBT\&TGT is a 16-item performance scale developed to clinically analyze postural stability, ambulation skills and dynamic balance control in elderly individuals.
Measured: Baseline administration (Day 1)
30-Second Chair Stand Test ( 30s-CST )
The 30s-CST is a widely used functional measurement tool for assessing lower extremity muscle endurance and dynamic balance performance.
Measured: Baseline administration (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start24 Jun 2024
- Primary completion1 Jul 2024
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkadir dağbaşı, Necmettin Erbakan University
- Investigators
- abdulkadir dağbaşı, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444061
- Sponsor's protocol ID
- ADagbasi003
- Status last verified
- May 2025
- First submitted
- 30 May 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soh SL, Tan CW, Xu T, Yeh TT, Bte Abdul Rahman F, Soon B, Gleeson N, Lane J. The Balance Recovery Confidence (BRC) Scale. Physiother Theory Pract. 2024 Mar 3;40(3):658-669. doi: 10.1080/09593985.2022.2135420. Epub 2022 Oct 19.
PubMed 36259660
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Psychometric Validation of the Balance Recovery Confidence Scale (BRCS) in Older Turkish Adults
- ClinicalTrials.gov ID
- NCT06444061
- Acronym / sponsor ID
- ADagbasi003
- Keywords
- Balance confidence, fall risk, cultural adaptation, geriatrics, psychometric properties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational cross-sectional study is to evaluate the cultural adaptation, reliability, and validity of the Turkish version of the Balance Recovery Confidence Scale (BRCS), named Dengeyi Düzeltmede Kendine Güven Ölçeği (DDKGÖ), in older Turkish adults aged 65 and above. The main questions it aims to answer are:
Does the Turkish adaptation (DDKGÖ) demonstrate acceptable cultural validity, internal consistency, and test-retest reliability in measuring balance recovery confidence?
How does the DDKGÖ correlate with established tools assessing fear of falling, balance confidence, and physical performance (e.g., FES-I, ABC, TUG) to confirm convergent validity?
Participants will:
Complete the DDKGÖ questionnaire twice (7 days apart) to assess test-retest reliability.
Undergo physical performance tests (e.g., Timed Up and Go, Handgrip Strength Test, 30-Second Chair Stand Test).
Provide responses to additional self-report scales (FES-I, ABC) to evaluate convergent validity.
This study focuses on community-dwelling older adults without severe cognitive or physical impairments. Results will help standardize the DDKGÖ as a tool for identifying fall risk and personalizing rehabilitation strategies in Turkish geriatric populations.
Detailed description
This observational psychometric study is designed to establish the cultural validity, reliability, and overall measurement performance of the Turkish adaptation of the Balance Recovery Confidence Scale (DDKGÖ) in community-dwelling older adults. After obtaining informed consent and confirming basic eligibility, participants will undergo a two-phase assessment protocol with a one-week interval between phases.
During Phase 1, each participant will complete a structured interview and self-report questionnaires in a single session. These include the 19-item DDKGÖ (to assess reactive balance confidence), the Falls Efficacy Scale-International, and the Activities-specific Balance Confidence Scale. Trained assessors will also record demographic and health information (e.g., age, sex, comorbidities, history of falls) and administer a battery of standardized performance tests-such as the Timed Up and Go, 30-Second Chair Stand, Tinetti Balance \& Gait, and Handgrip Strength tests-to evaluate convergent validity.
Exactly seven days later, in Phase 2, participants will return to repeat the DDKGÖ under identical conditions to evaluate test-retest stability. All sessions will be conducted in the same clinical setting by the same examiners, using standardized instructions and order of administration to minimize procedural variability.
Collected data will be anonymized and entered into a secure database. Statistical analyses will include exploratory and confirmatory factor analyses to examine structural validity, calculation of internal consistency (e.g., Cronbach's α), intraclass correlation coefficients for test-retest reliability, Bland-Altman limits of agreement to quantify measurement error, and correlation analyses with existing balance- and fear-of-fall measures and performance tests to establish convergent validity.
By following this stepwise process-translation verification, initial validity and reliability testing, and retest assessment-this study will provide a comprehensive evaluation of whether the DDKGÖ is suitable for use in both research and clinical practice to identify older Turkish adults at elevated fall risk and to monitor changes in their confidence to recover from postural disturbances.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study population will consist of community-dwelling older adults aged 65 years and older, recruited from a single center in Turkey. Participants must be literate in Turkish, capable of independent living (with or without walking aids), and able to perform basic mobility tasks such as walking 6 meters within 12 seconds. Exclusion criteria will include cognitive impairment (MMSE ≤23), mobility limitations (Timed Up and Go >12 seconds), recent fractures (within the last 6 months), severe cardiopulmonary or neurological conditions, and significant sensory impairments. Educational background, fall history, and sociodemographic characteristics will be documented to describe the sample.
Key inclusion criteria (5 listed)
- Age ≥65 years.
- Community-dwelling individuals capable of independent living (use of walking aids permitted).
- Literate in Turkish.
- Ability to complete 6 meters of walking within 12 seconds.
- Ability to grasp a 30 cm ruler with both hands.
Key exclusion criteria (9 listed)
- Requiring assisted mobility outside the home.
- Mini-Mental State Examination (MMSE) score ≤23.
- Timed Up and Go (TUG) test duration >12 seconds.
- Active malignancy or history of myocardial infarction/cardiac surgery within the last 3 months.
- Structural heart disease, severe COPD, or oxygen dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance Recovery Confidence Scale (BRCS)
Time frame: Start (initial assessment session, Day 1) and 7 days later (follow-up session on Day 8)
The BRCS is a 19-item self-report scale developed to assess individuals' perception of self-efficacy for the restoration of balance after postural perturbations (such as stumbling, slipping, sudden loss of balance).
6 secondary outcomes
Falls Efficacy Scale-International ( FES-I )
Time frame: Baseline administration (Day 1)
Activities-specific Balance Confidence Scale ( ABC )
Time frame: Baseline administration (Day 1)
Timed Up and Go ( TUG )
Time frame: Baseline administration (Day 1)
Handgrip Strength Test ( HGST )
Time frame: Baseline administration (Day 1)
Tinetti Balance & Gait Test ( TBT&TGT )
Time frame: Baseline administration (Day 1)
30-Second Chair Stand Test ( 30s-CST )
Time frame: Baseline administration (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 36259660Soh SL, Tan CW, Xu T, Yeh TT, Bte Abdul Rahman F, Soon B, Gleeson N, Lane J. The Balance Recovery Confidence (BRC) Scale. Physiother Theory Pract. 2024 Mar 3;40(3):658-669. doi: 10.1080/09593985.2022.2135420. Epub 2022 Oct 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abdulkadir dağbaşı principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls and Balance; Distorted, run by Necmettin Erbakan 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 25 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Recovery Confidence Scale (BRCS) (time frame: Start (initial assessment session, Day 1) and 7 days later (follow-up session on Day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06444061, which also lists 1 linked publication.
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 25 May 2025.