''The Agreement Between Face-to-face and Tele-assessment of Fullerton Advanced Balance (FAB) Scale in Older People''

Istanbul University - Cerrahpasa

Status: Not yet enrolling

Conditions: Geriatric Population; Fall Risk Assessment; Tele-assessment Reliability

Study type: Observational

Funder types: Other

Identifiers

NCT07178028

E-38981562-300-1300842

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

52 participants in 1 patient group

Older Adults ≥65 (Single Cohort)

Description:

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.