NCT07631975

Brief Summary

There is a need for studies that examine the role of dual-task cost in predicting fall risk among older adults receiving institutional care and that develop classification models that can be used in clinical practice. The planned study aims to determine the discriminative ability of dual-task cost in identifying fall risk and to establish clinically meaningful cutoff values. In this respect, the study will both contribute to a more sensitive assessment of fall risk and provide a scientific basis for a low-cost, practical, and applicable screening approach.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jun 2026

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

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

May 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

May 16, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Dual TaskDual-task costFall riskFunctional mobilityInstitutionalized older adults

Outcome Measures

Primary Outcomes (8)

  • Clinical Information Form

    The following participant information will be recorded using a clinical information form developed by the researcher: Age (years) Sex (male/female) Educational status(illitirate/primare education/secondary education/high school or higher) Length of institutional stay( months and years) Height(cm) Weight(kg) Body mass index BMI (kg/m²) Number of chronic diseases and comorbidities Number of daily medications Use of assistive devices

    Single assessment (baseline)

  • Fall Assesment

    Fall history (Tripping, Slipping, Loss of Balance, Transposition) Fall History Questionnaire A fall will be defined as an event which results in an individual coming to rest inadvertently on the ground, floor, or a lower level. In this context, the following information will be recorded: Presence of a fall within the last 12 months (yes/no) Total number of falls within the last 12 months Presence of a fall within the last month (yes/no) Primary cause of the last fall Location of the last fall Injury status resulting from the last fall

    Single assessment (baseline)

  • Montreal Cognitive Assessment (MoCA)

    This assessment will be utilized to determine whether participants possess the cognitive competence to understand and execute the study protocol. Individuals with a MoCA score below 18 will be excluded from the study.

    Single assessment (baseline)

  • Timed Up and Go Test (TUG)

    This test will be utilized to assess the functional mobility of the participants. The participant will be instructed to rise from a standard-height chair, walk a distance of 3 meters, turn around, return to the chair, and sit back down. The duration of the test will be recorded in seconds.

    Single assessment (baseline)

  • Dual-task Timed Up and Go Test (TUG-DT)

    This test will be administered to evaluate the dual-task performance of the participants. Participants will be instructed to simultaneously perform a cognitive task during the TUG test. Cognitive Task Animal naming will be utilized as the cognitive task under the dual-task condition. The participant will be asked to name as many animals as possible while walking. All participants will be assigned the same task, and standard verbal instructions will be utilized.

    Single assessment (baseline)

  • Dual-Task Cost (DTC)

    The dual-task cost will be calculated using the single-task TUG and dual-task TUG durations according to the following formula: DTC (%)"=(TUG\_DT-TUG)/TUG×100 An increase in the DTC percentage will indicate greater performance degradation under the dual-task condition.

    Single assessment (baseline)

  • Tinetti Performance-Oriented Mobility Assessment (POMA)

    This assessment will be utilized to evaluate the balance and gait performance of the participants. The total Tinetti score will be used to determine the risk of falls. Operational Definition of Fall Risk Fall risk will be operationalized in two ways in the study: As a continuous variable: Total Tinetti score As a binary classification variable: Risk group based on the Tinetti score Classification based on the Tinetti score will be structured as follows: Low fall risk: 25-28 points Increased fall risk: 24 points and below This binary classification will be utilized for the classification model and ROC analysis.

    Single assessment (baseline)

  • Falls Efficacy Scale-International (FES-I)

    This scale will be utilized to assess the participants' level of fear of falling as a descriptive and secondary variable. The FES-I score will not serve as a primary variable in the main model; however, it will be reported in descriptive analyses and secondary analyses as required.

    Single assessment (baseline)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population for this cross-sectional study consists of older adults residing in long-term care facilities and nursing homes. Participants will be selected based on the predefined inclusion criteria. These eligibility criteria are designed to ensure safety, cognitive comprehension, and physical compliance during the functional and dual-task assessments.

You may qualify if:

  • Being 65 years of age or older
  • Residing in a nursing home or care institution for at least 1 month
  • Ability to walk a distance of at least 10 meters
  • Ability to ambulate independently with an assistive device (e.g., cane, walker), if needed
  • Having a Montreal Cognitive Assessment (MoCA) score of 18 or above
  • Ability to understand and execute single- and two-step verbal commands
  • Voluntary agreement to participate in the study and providing informed consent

You may not qualify if:

  • History of stroke or major orthopedic surgery within the past 6 monthsPresence of Parkinson's disease Stage ≥3 (Hoehn \& Yahr) or any other neurological condition significantly affecting gait
  • Having a MoCA score below 18
  • History of fracture within the past 3 months
  • Presence of severe pain affecting gait during test administration (Visual Analog Scale \[VAS\] ≥ 7)
  • Uncontrolled hypertension (≥ 180/100 mmHg) or unstable cardiovascular status
  • Active vestibular disease or a history of syncope within the past 3 months
  • Visual or hearing impairment severe enough to impede test execution
  • Inability to walk/ambulate without the physical assistance of another person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ONDOKUZ MAYIS UNIVERSITY, Samsun, Atakum 55270

Samsun, 55270, Turkey (Türkiye)

Location

Central Study Contacts

Mine PEKESEN KURTÇA, ASISTANT PROFESSOR, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

May 16, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations