Older Adults (65 Years and Older)NCT07631975
ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK AMONG OLDER ADULTS RECEIVING INSTITUTIONAL CARE
An observational study of Older Adults (65 Years and Older) and INSTITUTIONAL CARE, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults (65 Years and Older), INSTITUTIONAL CARE, Dual Task Cost
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Nov 2026
- How long will I take part?
- 12 Months
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
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
ONDOKUZ MAYIS UNIVERSITY, Samsun, Atakum 55270
Samsun, 55270
MİNE PEKESEN P KURTÇA, PhD, +903623121919, mine.pekesenkurtca@omu.edu.tr
About this study
Official title: ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK IN OLDER ADULTS RECEIVING INSTITUTIONAL CARE: A CROSS-SECTIONAL CLASSIFICATION MODEL
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.
Read the detailed description
Changes in motor and cognitive functions that occur with the aging process negatively affect individuals' mobility and balance performance, there by increasing the risk of falls. Today, it is widely accepted that gait and postural control are not merely motor processes, but also require the active participation of attention and executive cognitive processes. In this context, the dual-task approach-wherein an individual simultaneously performs a second cognitive or motor task during gait-has become a widely utilized method for evaluating cognitive-motor interaction in older adults (Muir-Hunter \& Wittwer, 2016). Performance degradation under dual-task conditions is explained by the individual having to allocate limited cognitive resources between two tasks, a phenomenon that becomes particularly more pronounced in older adults. Studies in the literature examining the relationship between dual-task performance and falls demonstrate that performance changes occurring under dual-task conditions are more strongly associated with falls compared to single-task conditions (Muir-Hunter \& Wittwer, 2016). However, there is still no full consensus on which protocol, which secondary task, and which performance outcome are clinically most meaningful in dual-task assessments. The dual-task Timed Up and Go (TUG) test stands out as a practical and clinically applicable method for evaluating functional mobility. Tang et al. (2014) showed that motor dual-task TUG performance was superior to single-task TUG in discriminating the state of prefrailty in middle-aged and older adults. In the same study, it was reported that the ROC analysis of dual-task TUG performance showed significant discriminative power, and slow performance significantly increased the likelihood of prefrailty. These findings reveal that dual-task-based measurements are not only explanatory but also possess the potential to serve as classification tools and contribute to clinical decision-making processes. The relationship between cognitive functions and dual-task performance is another notable topic in the literature. It has been shown that both gait performance and cognitive performance deteriorate more markedly under dual-task conditions in individuals with mild cognitive impairment (Muir-Hunter \& Wittwer, 2016). Furthermore, it is indicated that the type and difficulty level of the secondary task used have significant effects on dual-task performance. This situation highlights the critical importance of standardizing dual-task assessments. Fear of falling is also a major factor affecting functional performance in older adults. In a study conducted by Sapmaz et al. (2021) on institutionalized older adults, it was shown that individuals with a fear of falling had worse single-task and dual-task TUG performances; additionally, their balance and mobility levels were also lower. These findings demonstrate that the fear of falling is not merely a psychological condition but is closely related to functional capacity. However, a large part of current studies remains at the group-comparison level, and analyses modeling the role of dual-task performance in predicting clinical fall risk remain limited. Recent studies show that dual-task assessments are highly sensitive in uncovering hidden functional impairments in older adults (Falbo et al., 2016). Especially in frail populations such as institutionalized older adults, dual-task performance is thought to be closely associated with falls. However, most of these studies either feature intervention-based designs or are limited strictly to correlation analyses. A prominent gap in the literature is the scarcity of studies evaluating fall risk via dual-task cost (which represents the relative change compared to single-task performance) rather than absolute measurements of dual-task performance. Because dual-task cost reflects the relative deterioration in an individual's performance under cognitive load, it may serve as a clinically more meaningful indicator. Nevertheless, studies examining the role of dual-task cost in discriminating fall risk and establishing a cross-sectional classification model based on this variable remain highly limited.
- Keywords
- Dual Task, Dual-task cost, Fall risk, Functional mobility, Institutionalized older adults
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single assessment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- 52 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MİNE PEKESEN KURTÇA, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631975
- Sponsor's protocol ID
- 2026/276
- Status last verified
- Jun 2026
- First submitted
- 16 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK IN OLDER ADULTS RECEIVING INSTITUTIONAL CARE: A CROSS-SECTIONAL CLASSIFICATION MODEL
- ClinicalTrials.gov ID
- NCT07631975
- Acronym / sponsor ID
- 2026/276
- Keywords
- Dual Task, Dual-task cost, Fall risk, Functional mobility, Institutionalized older adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Jun 2026 (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.
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.
Detailed description
Changes in motor and cognitive functions that occur with the aging process negatively affect individuals' mobility and balance performance, there by increasing the risk of falls. Today, it is widely accepted that gait and postural control are not merely motor processes, but also require the active participation of attention and executive cognitive processes. In this context, the dual-task approach-wherein an individual simultaneously performs a second cognitive or motor task during gait-has become a widely utilized method for evaluating cognitive-motor interaction in older adults (Muir-Hunter \& Wittwer, 2016). Performance degradation under dual-task conditions is explained by the individual having to allocate limited cognitive resources between two tasks, a phenomenon that becomes particularly more pronounced in older adults. Studies in the literature examining the relationship between dual-task performance and falls demonstrate that performance changes occurring under dual-task conditions are more strongly associated with falls compared to single-task conditions (Muir-Hunter \& Wittwer, 2016). However, there is still no full consensus on which protocol, which secondary task, and which performance outcome are clinically most meaningful in dual-task assessments. The dual-task Timed Up and Go (TUG) test stands out as a practical and clinically applicable method for evaluating functional mobility. Tang et al. (2014) showed that motor dual-task TUG performance was superior to single-task TUG in discriminating the state of prefrailty in middle-aged and older adults. In the same study, it was reported that the ROC analysis of dual-task TUG performance showed significant discriminative power, and slow performance significantly increased the likelihood of prefrailty. These findings reveal that dual-task-based measurements are not only explanatory but also possess the potential to serve as classification tools and contribute to clinical decision-making processes. The relationship between cognitive functions and dual-task performance is another notable topic in the literature. It has been shown that both gait performance and cognitive performance deteriorate more markedly under dual-task conditions in individuals with mild cognitive impairment (Muir-Hunter \& Wittwer, 2016). Furthermore, it is indicated that the type and difficulty level of the secondary task used have significant effects on dual-task performance. This situation highlights the critical importance of standardizing dual-task assessments. Fear of falling is also a major factor affecting functional performance in older adults. In a study conducted by Sapmaz et al. (2021) on institutionalized older adults, it was shown that individuals with a fear of falling had worse single-task and dual-task TUG performances; additionally, their balance and mobility levels were also lower. These findings demonstrate that the fear of falling is not merely a psychological condition but is closely related to functional capacity. However, a large part of current studies remains at the group-comparison level, and analyses modeling the role of dual-task performance in predicting clinical fall risk remain limited. Recent studies show that dual-task assessments are highly sensitive in uncovering hidden functional impairments in older adults (Falbo et al., 2016). Especially in frail populations such as institutionalized older adults, dual-task performance is thought to be closely associated with falls. However, most of these studies either feature intervention-based designs or are limited strictly to correlation analyses. A prominent gap in the literature is the scarcity of studies evaluating fall risk via dual-task cost (which represents the relative change compared to single-task performance) rather than absolute measurements of dual-task performance. Because dual-task cost reflects the relative deterioration in an individual's performance under cognitive load, it may serve as a clinically more meaningful indicator. Nevertheless, studies examining the role of dual-task cost in discriminating fall risk and establishing a cross-sectional classification model based on this variable remain highly limited.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
Clinical Information Form
Time frame: Single assessment (baseline)
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
Fall Assesment
Time frame: Single assessment (baseline)
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
Montreal Cognitive Assessment (MoCA)
Time frame: Single assessment (baseline)
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.
Timed Up and Go Test (TUG)
Time frame: Single assessment (baseline)
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.
Dual-task Timed Up and Go Test (TUG-DT)
Time frame: Single assessment (baseline)
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.
Dual-Task Cost (DTC)
Time frame: Single assessment (baseline)
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.
Tinetti Performance-Oriented Mobility Assessment (POMA)
Time frame: Single assessment (baseline)
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.
Falls Efficacy Scale-International (FES-I)
Time frame: Single assessment (baseline)
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.
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 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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 Older Adults (65 Years and Older) and INSTITUTIONAL CARE, run by Ondokuz Mayıs 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 Jun 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?
Contact Mine PEKESEN KURTÇA, ASISTANT PROFESSOR, PhD (+903623121919, mine.pekesenkurtca@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Information Form (time frame: Single assessment (baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.