NCT07178028

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

September 17, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

September 10, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

Fullerton Advanced Balance ScaleTelehealthFall riskTele-assessmentOlder adultsBalance

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 7 days after first assessment

Secondary Outcomes (3)

  • Completion rate

    During tele-assessment session (Day 1)

  • Participant Satisfaction Survey

    Immediately after completion of the tele-assessment

  • The Telehealth Usability Questionnaire (TUQ)

    Immediately after completion of the tele-assessment

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Fakültesi

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 17084123BACKGROUND
  • Klein 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.

    PMID: 22210989BACKGROUND
  • Jasper 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.

    PMID: 39868692BACKGROUND
  • Chan 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.

    PMID: 33120138BACKGROUND

Study Officials

  • Ayşe Zengin Alpözgen, Assoc. Prof.

    İstanbul University - Cerrahpaşa

    STUDY DIRECTOR

Central Study Contacts

Noura Salah Abdulhalim, Lisans

CONTACT

Ayşe Zengin Alpözgen, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

September 20, 2025

Primary Completion

December 20, 2025

Study Completion

January 15, 2026

Last Updated

September 17, 2025

Record last verified: 2025-06

Locations