Fall Risk AssessmentFABNCT07178028
''The Agreement Between Face-to-face and Tele-assessment of Fullerton Advanced Balance (FAB) Scale in Older People''
An observational study of Fall Risk Assessment and Tele-assessment Reliability, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the measurement consistency and reliability of the Fullerton Advanced Balance Scale (FAGBS) between the tele-assessment method and the face-to-face assessment method. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Risk Assessment, Tele-assessment Reliability, Geriatric Population
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 25 May 2026
- 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
- Healthy volunteers accepted
- Older adult
Study population: This study will recruit community-dwelling older adults aged 65 years and above who are able to walk without assistance or with an assistive device. Participants must have a Mini-Mental State Examination (MMSE) score of 24 or higher and possess adequate vision and hearing to understand test instructions. They must also have access to the necessary technology and environment to participate in video-based tele-assessment. Individuals with recent acute conditions affecting balance, advanced neurological or orthopedic disorders, significant systemic medical instability, severe psychiatric illness, or insufficient technical/social support for tele-assessment will be excluded.
Who may be able to join
- Being 65 years of age or older
- Able to walk independently, even if using an assistive device
- Having a Mini-Mental State Examination (MMSE) score of ≥ 24
- Having adequate vision and hearing (able to read and understand test instructions and information materials)
- Having the necessary technical equipment and a suitable environment to participate in video conference assessments
- Providing voluntary written informed consent
Who cannot join
- History of acute conditions in the past month that may temporarily affect balance (e.g., lower limb trauma, ankle sprain, acute vestibular problems)
- History of advanced neurological diseases such as Parkinson's disease, multiple sclerosis, or stroke sequelae
- Serious orthopedic problems limiting lower limb function (e.g., recent surgery, significant movement restriction)
- Systemic medical instability that may affect balance, such as uncontrolled diabetes or advanced heart failure
- Psychiatric disorders severe enough to significantly impair communication or the assessment process
- Insufficient technical equipment, environmental support, or social resources to participate in the tele-assessment process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Fakültesi
Istanbul, Büyükçekmece, 34500
About this study
The purpose of this study is to examine the measurement consistency and reliability of the Fullerton Advanced Balance Scale (FAGBS) between the tele-assessment method and the face-to-face assessment method. In line with increasing telehealth applications, researching the remote applicability of balance assessment tools is clinically important. In this context, the remote applicability of the FAGBS will be evaluated based on measurement comparability and participant experience. Research Design: This study is an observational, cross-sectional, methodological research conducted using a randomized crossover design. Measurement consistency and reliability will be compared between two different application methods (tele-assessment and face-to-face) of a measurement tool.
Hypotheses:
Read more
H₀: There is no significant consistency in terms of measurement between the tele-assessment method and the face-to-face assessment method of the Fullerton Advanced Balance Scale.
H₁: There is a significant level of consistency in measurement between the tele-assessment method and the face-to-face assessment method of the Fullerton Advanced Balance Scale.
Participants will be randomly assigned to first undergo the FAGBS using either the face-to-face or tele-assessment method, and then reassessed using the other method within 7 days. All applications will be conducted by the same physical therapist; tele-assessment will be conducted simultaneously via the Zoom platform, and sessions will be recorded. Inter-measure consistency will be assessed using ICC, error levels using SEM and MDC, and inter-method measurement agreement using Bland-Altman analysis. Convergent validity will be assessed using the FES-I (Falls Efficacy Scale - International). Additionally, feasibility, test completion rate, and participant satisfaction will be evaluated using a questionnaire. Expected Contributions: This research will provide scientific evidence that FAGBS can be applied validly and reliably using a tele-assessment method. Thus, it will enable the remote assessment of fall risk in elderly individuals in situations where face-to-face access is limited. The study will provide meaningful contributions to the standardization and integration of tele-assessment applications into clinical practice in the field of physical therapy.
Read the detailed description
Research Design:
This is an observational, cross-sectional methodological study examining the measurement consistency and reliability between tele-assessment and face-to-face applications of the Fullerton Advanced Balance Scale (FAGBS). The study will use a randomized crossover design, with data collection planned between September and January 2026.
Sample:
Participants will be individuals aged 65 and older living in Istanbul and affiliated with institutions under the Darülaceze Presidency. Purposive sampling will be used, and recruitment will occur through the university's physical therapy unit, hospital waiting areas, neighborhood pharmacies, municipal senior centers, and social networks. Participation is voluntary.
The sample size was calculated using an ICC-based hypothesis testing approach (Walter et al., 1998) assuming an expected ICC of 0.90, a minimum acceptable ICC of 0.75, α = 0.05, and 90% power. A minimum of 44 participants is required; accounting for 15% attrition, the target sample size is 52.
Assessment Procedures:
All assessments will be performed by the same physical therapist following a standardized protocol. Face-to-face assessments will take place at the Department of Physical Therapy and Rehabilitation at Istanbul University-Cerrahpaşa or Darülaceze institutions. Tele-assessments will be conducted synchronously via Zoom or WhatsApp. Participants will be randomized to either face-to-face assessment followed by tele-assessment, or vice versa, with a 7-day interval between repeated tele-assessments.
Participants will receive instructions on device setup, camera positioning, and safety measures. A companion is recommended for safety, and sessions may be video recorded with consent. Assessments will be conducted in a quiet, well-lit area with a non-slip floor, and the camera positioned approximately 2-3 meters away to capture full-body movements. Participants without compatible devices will be provided with a computer and technical guidance. Assessments will be paused if fatigue, dizziness, or fall risk occurs. Physical performance tests are brief (~10 minutes), and a rest period of 1.5-2 hours will be scheduled between assessments, extendable if needed. Internet interruptions will be managed with reconnection attempts and rescheduling if necessary.
Statistical Analysis:
Data will be analyzed using SPSS 24.0. Reliability between tele-assessment and face-to-face FAGBS applications will be evaluated using the Intraclass Correlation Coefficient (ICC), including inter-observer reliability for tele-assessment. Measurement consistency will be assessed via Bland-Altman analysis. Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) will be calculated for measurement sensitivity. Concurrent validity between FAGBS and FES-I scores will be examined using Spearman's correlation. Participant satisfaction, completion rates, and Telehealth Usability Questionnaire results will be reported descriptively (mean, standard deviation, frequency, and percentage).
- Keywords
- Fullerton Advanced Balance Scale, Telehealth, Fall risk, Tele-assessment, Older adults, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults ≥65 (Single Cohort) | Single cohort of individuals aged 65 and older, residing in Istanbul and affiliated with institutions under the Darülaceze Presidency. Participants will undergo both face-to-face and tele-assessment in a randomized crossover design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fullerton Advanced Balance Scale
The Fullerton Advanced Balance Scale (FABS) is a performance-based tool that measures functional balance in older adults. It consists of 10 items scored from 0-4 points, with a total score range of 0-40. Higher scores indicate better balance. The scale assesses components such as static and dynamic balance, anticipatory and reactive postural control. Assessments will be administered by a trained physical therapist in both face-to-face and tele-assessment formats.
Measured: Baseline and 7 days after first assessment
Secondary outcomes (3)
Completion rate
The proportion of participants who fully complete the tele-assessment session will be recorded. Completion is defined as finishing all items of the Fullerton Advanced Balance Scale (FABS) without discontinuation. The rate will be reported as a percentage of enrolled participants.
Measured: During tele-assessment session (Day 1)
Participant Satisfaction Survey
A 5-item Likert-type survey will be used to evaluate participants' experience with the tele-assessment. Items assess clarity of instructions, physical feasibility, presence of technical difficulties, overall satisfaction, and willingness to use the method again. Each item is rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater satisfaction.
Measured: Immediately after completion of the tele-assessment
The Telehealth Usability Questionnaire (TUQ)
The Telehealth Usability Questionnaire (TUQ) will assess participants' perceptions of the usability of the tele-assessment system. TUQ is a validated self-report measure with multiple domains, including clarity of the interface, technical adequacy, communication quality, user satisfaction, and overall preference. Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with higher scores indicating better usability.
Measured: Immediately after completion of the tele-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Oct 2025
- Primary completion24 Mar 2026
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fall Risk AssessmentStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Zengin Alpözgen, Assoc. Prof., Study director, İstanbul University - Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178028
- Sponsor's protocol ID
- E-38981562-300-1300842
- Acronym
- FAB
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rose DJ, Lucchese N, Wiersma LD. Development of a multidimensional balance scale for use with functionally independent older adults. Arch Phys Med Rehabil. 2006 Nov;87(11):1478-85. doi: 10.1016/j.apmr.2006.07.263.
PubMed 17084123Klein PJ, Fiedler RC, Rose DJ. Rasch Analysis of the Fullerton Advanced Balance (FAB) Scale. Physiother Can. 2011 Winter;63(1):115-25. doi: 10.3138/ptc.2009-51. Epub 2011 Jan 20.
PubMed 22210989Jasper A, Karim R, Vitente AC, Rafael CM, Tayag E, Uy SJM, Baloy RK, Lazaro R. Concurrent Validity and Reliability of In-Person and Supervised Remote STEADI Fall Risk Assessment in Community-Dwelling Older Adults. J Geriatr Phys Ther. 2025 Jan 27. doi: 10.1519/JPT.0000000000000446. Online ahead of print.
PubMed 39868692Chan JKY, Klainin-Yobas P, Chi Y, Gan JKE, Chow G, Wu XV. The effectiveness of e-interventions on fall, neuromuscular functions and quality of life in community-dwelling older adults: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Jan;113:103784. doi: 10.1016/j.ijnurstu.2020.103784. Epub 2020 Oct 3.
PubMed 33120138
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''The Agreement Between Face-to-face and Tele-assessment of Fullerton Advanced Balance (FAB) Scale in Older People''
- ClinicalTrials.gov ID
- NCT07178028
- Acronym / sponsor ID
- FAB / E-38981562-300-1300842
- Keywords
- Fullerton Advanced Balance Scale, Telehealth, Fall risk, Tele-assessment, Older adults, Balance
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 17 Sep 2025 (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 purpose of this study is to examine the measurement consistency and reliability of the Fullerton Advanced Balance Scale (FAGBS) between the tele-assessment method and the face-to-face assessment method. In line with increasing telehealth applications, researching the remote applicability of balance assessment tools is clinically important. In this context, the remote applicability of the FAGBS will be evaluated based on measurement comparability and participant experience. Research Design: This study is an observational, cross-sectional, methodological research conducted using a randomized crossover design. Measurement consistency and reliability will be compared between two different application methods (tele-assessment and face-to-face) of a measurement tool.
Hypotheses:
H₀: There is no significant consistency in terms of measurement between the tele-assessment method and the face-to-face assessment method of the Fullerton Advanced Balance Scale.
H₁: There is a significant level of consistency in measurement between the tele-assessment method and the face-to-face assessment method of the Fullerton Advanced Balance Scale.
Participants will be randomly assigned to first undergo the FAGBS using either the face-to-face or tele-assessment method, and then reassessed using the other method within 7 days. All applications will be conducted by the same physical therapist; tele-assessment will be conducted simultaneously via the Zoom platform, and sessions will be recorded. Inter-measure consistency will be assessed using ICC, error levels using SEM and MDC, and inter-method measurement agreement using Bland-Altman analysis. Convergent validity will be assessed using the FES-I (Falls Efficacy Scale - International). Additionally, feasibility, test completion rate, and participant satisfaction will be evaluated using a questionnaire. Expected Contributions: This research will provide scientific evidence that FAGBS can be applied validly and reliably using a tele-assessment method. Thus, it will enable the remote assessment of fall risk in elderly individuals in situations where face-to-face access is limited. The study will provide meaningful contributions to the standardization and integration of tele-assessment applications into clinical practice in the field of physical therapy.
Detailed description
Research Design:
This is an observational, cross-sectional methodological study examining the measurement consistency and reliability between tele-assessment and face-to-face applications of the Fullerton Advanced Balance Scale (FAGBS). The study will use a randomized crossover design, with data collection planned between September and January 2026.
Sample:
Participants will be individuals aged 65 and older living in Istanbul and affiliated with institutions under the Darülaceze Presidency. Purposive sampling will be used, and recruitment will occur through the university's physical therapy unit, hospital waiting areas, neighborhood pharmacies, municipal senior centers, and social networks. Participation is voluntary.
The sample size was calculated using an ICC-based hypothesis testing approach (Walter et al., 1998) assuming an expected ICC of 0.90, a minimum acceptable ICC of 0.75, α = 0.05, and 90% power. A minimum of 44 participants is required; accounting for 15% attrition, the target sample size is 52.
Assessment Procedures:
All assessments will be performed by the same physical therapist following a standardized protocol. Face-to-face assessments will take place at the Department of Physical Therapy and Rehabilitation at Istanbul University-Cerrahpaşa or Darülaceze institutions. Tele-assessments will be conducted synchronously via Zoom or WhatsApp. Participants will be randomized to either face-to-face assessment followed by tele-assessment, or vice versa, with a 7-day interval between repeated tele-assessments.
Participants will receive instructions on device setup, camera positioning, and safety measures. A companion is recommended for safety, and sessions may be video recorded with consent. Assessments will be conducted in a quiet, well-lit area with a non-slip floor, and the camera positioned approximately 2-3 meters away to capture full-body movements. Participants without compatible devices will be provided with a computer and technical guidance. Assessments will be paused if fatigue, dizziness, or fall risk occurs. Physical performance tests are brief (~10 minutes), and a rest period of 1.5-2 hours will be scheduled between assessments, extendable if needed. Internet interruptions will be managed with reconnection attempts and rescheduling if necessary.
Statistical Analysis:
Data will be analyzed using SPSS 24.0. Reliability between tele-assessment and face-to-face FAGBS applications will be evaluated using the Intraclass Correlation Coefficient (ICC), including inter-observer reliability for tele-assessment. Measurement consistency will be assessed via Bland-Altman analysis. Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC) will be calculated for measurement sensitivity. Concurrent validity between FAGBS and FES-I scores will be examined using Spearman's correlation. Participant satisfaction, completion rates, and Telehealth Usability Questionnaire results will be reported descriptively (mean, standard deviation, frequency, and percentage).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults ≥65 (Single Cohort) | – | –Single cohort of individuals aged 65 and older, residing in Istanbul and affiliated with institutions under the Darülaceze Presidency. Participants will undergo both face-to-face and tele-assessment in a randomized crossover design. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will recruit community-dwelling older adults aged 65 years and above who are able to walk without assistance or with an assistive device. Participants must have a Mini-Mental State Examination (MMSE) score of 24 or higher and possess adequate vision and hearing to understand test instructions. They must also have access to the necessary technology and environment to participate in video-based tele-assessment. Individuals with recent acute conditions affecting balance, advanced neurological or orthopedic disorders, significant systemic medical instability, severe psychiatric illness, or insufficient technical/social support for tele-assessment will be excluded.
Key inclusion criteria (6 listed)
- Being 65 years of age or older
- Able to walk independently, even if using an assistive device
- Having a Mini-Mental State Examination (MMSE) score of ≥ 24
- Having adequate vision and hearing (able to read and understand test instructions and information materials)
- Having the necessary technical equipment and a suitable environment to participate in video conference assessments
Key exclusion criteria (6 listed)
- History of acute conditions in the past month that may temporarily affect balance (e.g., lower limb trauma, ankle sprain, acute vestibular problems)
- History of advanced neurological diseases such as Parkinson's disease, multiple sclerosis, or stroke sequelae
- Serious orthopedic problems limiting lower limb function (e.g., recent surgery, significant movement restriction)
- Systemic medical instability that may affect balance, such as uncontrolled diabetes or advanced heart failure
- Psychiatric disorders severe enough to significantly impair communication or the assessment process
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
Fullerton Advanced Balance Scale
Time frame: Baseline and 7 days after first assessment
The Fullerton Advanced Balance Scale (FABS) is a performance-based tool that measures functional balance in older adults. It consists of 10 items scored from 0-4 points, with a total score range of 0-40. Higher scores indicate better balance. The scale assesses components such as static and dynamic balance, anticipatory and reactive postural control. Assessments will be administered by a trained physical therapist in both face-to-face and tele-assessment formats.
3 secondary outcomes
Completion rate
Time frame: During tele-assessment session (Day 1)
Participant Satisfaction Survey
Time frame: Immediately after completion of the tele-assessment
The Telehealth Usability Questionnaire (TUQ)
Time frame: Immediately after completion of the tele-assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 17084123Rose DJ, Lucchese N, Wiersma LD. Development of a multidimensional balance scale for use with functionally independent older adults. Arch Phys Med Rehabil. 2006 Nov;87(11):1478-85. doi: 10.1016/j.apmr.2006.07.263.
- Background: PubMed 22210989Klein PJ, Fiedler RC, Rose DJ. Rasch Analysis of the Fullerton Advanced Balance (FAB) Scale. Physiother Can. 2011 Winter;63(1):115-25. doi: 10.3138/ptc.2009-51. Epub 2011 Jan 20.
- Background: PubMed 39868692Jasper A, Karim R, Vitente AC, Rafael CM, Tayag E, Uy SJM, Baloy RK, Lazaro R. Concurrent Validity and Reliability of In-Person and Supervised Remote STEADI Fall Risk Assessment in Community-Dwelling Older Adults. J Geriatr Phys Ther. 2025 Jan 27. doi: 10.1519/JPT.0000000000000446. Online ahead of print.
- Background: PubMed 33120138Chan JKY, Klainin-Yobas P, Chi Y, Gan JKE, Chow G, Wu XV. The effectiveness of e-interventions on fall, neuromuscular functions and quality of life in community-dwelling older adults: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Jan;113:103784. doi: 10.1016/j.ijnurstu.2020.103784. Epub 2020 Oct 3.
- 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.
Ayşe Zengin Alpözgen, Assoc. Prof. study director
İstanbul University - Cerrahpaşa
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 Fall Risk Assessment and Tele-assessment Reliability, run by Istanbul University - Cerrahpasa 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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 18 May 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?
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?
Fullerton Advanced Balance Scale (time frame: Baseline and 7 days after first assessment). 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 NCT07178028, which also lists 4 linked publications.
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 18 May 2026.