Functional MobilityNCT07362212
Virtual Reality-Based Functional Mobility Tests in Older Adults
An observational study of Functional Mobility and Virtual Reality-Based Functional Assessment, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Objective assessment of mobility, balance, and lower extremity function in older adults is of great importance in both clinical practice and scientific research. For this purpose, performance-based tests that can be administered in a short time, are easily repeatable, and have high clinical practicality are widely… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Mobility, Virtual Reality-Based Functional Assessment
- What is being tested?
- Clinical Assessments
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 30 Jul 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: Community-dwelling adults aged 65 years and older who are able to ambulate independently (with or without assistive devices) and can communicate and follow test instructions.
Who may be able to join
- Aged 65 years or older,
- Ability to ambulate independently (assistive devices permitted),
- Cognitive ability sufficient to communicate and follow instructions,
- Provision of written informed consent.
Who cannot join
- Acute cardiopulmonary disease,
- Uncontrolled hypertension,
- History of lower extremity surgery or fracture within the past 6 months,
- Severe cognitive impairment preventing cooperation with testing procedures,
- Determination by a healthcare professional that participation is unsafe for safety-related reasons.
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
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Konya, Selcuklu, 42130
Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr
About this study
Official title: Validity, Reliability, and Clinical Correlates of Virtual Reality Adaptations of the 4-meter Walk Test, Five Times Sit-to-stand Test, and Timed up and go Test in Older Adults
Objective assessment of mobility, balance, and lower extremity function in older adults is of great importance in both clinical practice and scientific research. For this purpose, performance-based tests that can be administered in a short time, are easily repeatable, and have high clinical practicality are widely preferred. These tests provide valuable information about older adults' ability to perform activities of daily living, levels of functional independence, and risk of falls, thereby contributing significantly to both diagnostic processes and treatment planning.
One of these tests, the 4-Meter Walk Test (4MWT), is among the simplest and most reliable methods used to assess walking speed in older adults. Gait speed is considered a strong indicator of functional capacity and overall health status in older individuals and is also used as a critical parameter for predicting mortality, morbidity, hospitalization rates, and duration of independent living. Therefore, due to its short administration time, high repeatability, and clinical validity, the 4MWT has become one of the standard assessment tools in the field of geriatrics.
Read more
Another frequently used assessment tool, the Five-Times Sit-to-Stand Test (5xSTS), is based on measuring the time required for an individual to consecutively stand up from and sit down on a chair five times. This test is closely associated with lower extremity muscle strength, functional independence, and the ability to maintain activities of daily living. In addition, the 5xSTS test is an important clinical tool for identifying muscle weakness and mobility limitations in older adults with a history of falls. Owing to its short administration time, lack of requirement for specialized equipment, and ease of understanding, it is widely used in both clinical settings and field studies.
In addition, the Timed Up and Go (TUG) test is considered one of the gold standard methods for the assessment of functional mobility. The test is simple to administer: the time required for an individual to stand up from a chair, walk a specified distance, turn around, and return to sit down is measured. The TUG test not only assesses mobility but is also a reliable and valid method for predicting balance impairments and fall risk. Given that falls represent a major health concern in older adults, data obtained from the TUG test provide valuable guidance for both clinicians and researchers.
In recent years, virtual reality (VR)-based assessment methods have attracted increasing attention due to their potential to provide a safe, motivating, and standardized environment, particularly for older adults. In this study, the Meta Quest 3 virtual reality headset and controllers will be used to implement VR-based functional tests. The Meta Quest 3 device features a resolution of 2064 × 2208 pixels per eye, a maximum refresh rate of 120 Hz, and a six-degrees-of-freedom (6 DoF) inside-out tracking system. The device tracks participants' head and body movements in real time and accurately reflects them within the virtual environment. This system does not require external sensors and automatically provides positional tracking in the virtual space. Previous studies have demonstrated that VR applications can produce valid and reliable outcomes when used as digital adaptations of functional tests. However, the validity and reliability of VR adaptations of the 4MWT, 5xSTS, and TUG tests in older adults have not yet been systematically investigated.
The rationale of this study is to determine whether VR-based short performance tests can serve as a safer, more easily repeatable, and potentially more accessible alternative to conventional clinical assessments. The findings of this study are expected to provide important evidence supporting the use of VR technology in clinical practice for the assessment of mobility and balance in older adults.
- Being tested
- Clinical Assessments
- Keywords
- Older Adults, Functional Mobility, Virtual Reality, 4-Meter Walk Test, Five-Times Sit-to-Stand Test, Timed Up and Go Test, Validity and Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical AssessmentsOther
Participants will perform virtual reality-based adaptations of the 4-Meter Walk Test, Five-Times Sit-to-Stand Test, and Timed Up and Go Test using an immersive virtual reality application developed for the Meta Quest 3 platform. The virtual environment digitally replicates the conventional test setups and protocols, and performance outcomes are automatically recorded by the system. Virtual reality-based assessments will be compared with conventional clinical tests and repeated to evaluate validity, reliability, and clinical correlates.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults | Older adults undergoing conventional and virtual reality-based assessments of functional mobility, balance, and lower extremity function, including the 4-Meter Walk Test, Five-Times Sit-to-Stand Test, and Timed Up and Go Test, to evaluate validity, reliability, and clinical correlates. Receives: Other: Clinical Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-Meter Walk Test - Virtual Reality (4MWT-VR)
This outcome measure will be used to assess gait speed using a virtual reality-based adaptation of the 4-Meter Walk Test. Walking speed will be automatically calculated by the system. Validity will be evaluated by comparison with the conventional 4-Meter Walk Test, and reliability will be assessed using repeated measurements performed 5-7 days apart.
Measured: Baseline and 5-7 days
Five-Times Sit-to-Stand Test - Virtual Reality (5xSTS-VR)
This outcome measure will be used to assess lower extremity functional performance using a virtual reality-based adaptation of the Five-Times Sit-to-Stand Test. Test duration will be automatically recorded. Validity and reliability will be evaluated by comparison with the conventional test and repeated measurements.
Measured: Baseline and 5-7 days
Timed Up and Go Test - Virtual Reality (TUG-VR)
This outcome measure will be used to assess functional mobility using a virtual reality-based adaptation of the Timed Up and Go test. Test completion time will be automatically recorded by the system. Validity and reliability will be examined through comparison with the conventional Timed Up and Go test and repeated measurements.
Measured: Baseline and 5-7 days
Secondary outcomes (5)
4-Meter Walk Test - Conventional
The conventional 4-Meter Walk Test will be administered to assess gait speed and will be used as a reference measure for concurrent validity analyses.
Measured: Baseline
Five-Times Sit-to-Stand Test - Conventional
The conventional Five-Times Sit-to-Stand Test will be used to assess lower extremity muscle strength and functional mobility and will serve as a reference for validity analyses.
Measured: Baseline
Timed Up and Go Test - Conventional
The conventional Timed Up and Go test will be administered to assess functional mobility and fall risk and will be used as a reference for concurrent validity analyses.
Measured: Baseline
Lower Extremity Muscle Strength
Lower extremity muscle strength will be measured using standardized clinical methods and will be examined for its relationship with virtual reality-based performance test outcomes.
Measured: Baseline
Physical Activity Level (International Physical Activity Questionnaire - Short Form, IPAQ-SF)
Physical activity level will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF) and will be analyzed as a clinical correlate of virtual reality-based functional performance tests.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Functional MobilityStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaan ALTUNOK, Selcuk University
- Investigators
- İsmail ÖZSOY, Assoc. Prof. Dr., Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeGülşah ÖZSOY, Assist. Prof. Dr., Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeZehra KORKUT, Assist. Prof. Dr., Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeMehmet A GÜLER, PhD, Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeYasemin GEDİKLİ ERTÜRK, MSc. in PT, Study chair, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, TürkiyeMuhammed İ KODAK, Assist. Prof. Dr., Study chair, Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, TürkiyeAhmet ÇİZMECİOĞLU, Assoc. Prof. Dr., Study chair, Selcuk University, Faculty of Medicine, Department of Internal Medicine, Konya, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362212
- Sponsor's protocol ID
- SelcukU_PT_OP_VR_ADAPTATION_1
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
PubMed 21058606Maden C, Gozacan Karabulut D, Bagci B. Validity and reliability of an immersive virtual reality adaptation of the 6-minute pegboard and ring test. Hand Surg Rehabil. 2025 Feb;44(1):101981. doi: 10.1016/j.hansur.2024.101981. Epub 2024 Oct 30.
PubMed 39486588Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.
PubMed 24484314Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
PubMed 7624188Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
PubMed 21205966
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability, and Clinical Correlates of Virtual Reality Adaptations of the 4-meter Walk Test, Five Times Sit-to-stand Test, and Timed up and go Test in Older Adults
- ClinicalTrials.gov ID
- NCT07362212
- Acronym / sponsor ID
- SelcukU_PT_OP_VR_ADAPTATION_1
- Keywords
- Older Adults, Functional Mobility, Virtual Reality, 4-Meter Walk Test, Five-Times Sit-to-Stand Test, Timed Up and Go Test, Validity and Reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Jan 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.
Objective assessment of mobility, balance, and lower extremity function in older adults is of great importance in both clinical practice and scientific research. For this purpose, performance-based tests that can be administered in a short time, are easily repeatable, and have high clinical practicality are widely preferred. These tests provide valuable information about older adults' ability to perform activities of daily living, levels of functional independence, and risk of falls, thereby contributing significantly to both diagnostic processes and treatment planning.
One of these tests, the 4-Meter Walk Test (4MWT), is among the simplest and most reliable methods used to assess walking speed in older adults. Gait speed is considered a strong indicator of functional capacity and overall health status in older individuals and is also used as a critical parameter for predicting mortality, morbidity, hospitalization rates, and duration of independent living. Therefore, due to its short administration time, high repeatability, and clinical validity, the 4MWT has become one of the standard assessment tools in the field of geriatrics.
Another frequently used assessment tool, the Five-Times Sit-to-Stand Test (5xSTS), is based on measuring the time required for an individual to consecutively stand up from and sit down on a chair five times. This test is closely associated with lower extremity muscle strength, functional independence, and the ability to maintain activities of daily living. In addition, the 5xSTS test is an important clinical tool for identifying muscle weakness and mobility limitations in older adults with a history of falls. Owing to its short administration time, lack of requirement for specialized equipment, and ease of understanding, it is widely used in both clinical settings and field studies.
In addition, the Timed Up and Go (TUG) test is considered one of the gold standard methods for the assessment of functional mobility. The test is simple to administer: the time required for an individual to stand up from a chair, walk a specified distance, turn around, and return to sit down is measured. The TUG test not only assesses mobility but is also a reliable and valid method for predicting balance impairments and fall risk. Given that falls represent a major health concern in older adults, data obtained from the TUG test provide valuable guidance for both clinicians and researchers.
In recent years, virtual reality (VR)-based assessment methods have attracted increasing attention due to their potential to provide a safe, motivating, and standardized environment, particularly for older adults. In this study, the Meta Quest 3 virtual reality headset and controllers will be used to implement VR-based functional tests. The Meta Quest 3 device features a resolution of 2064 × 2208 pixels per eye, a maximum refresh rate of 120 Hz, and a six-degrees-of-freedom (6 DoF) inside-out tracking system. The device tracks participants' head and body movements in real time and accurately reflects them within the virtual environment. This system does not require external sensors and automatically provides positional tracking in the virtual space. Previous studies have demonstrated that VR applications can produce valid and reliable outcomes when used as digital adaptations of functional tests. However, the validity and reliability of VR adaptations of the 4MWT, 5xSTS, and TUG tests in older adults have not yet been systematically investigated.
The rationale of this study is to determine whether VR-based short performance tests can serve as a safer, more easily repeatable, and potentially more accessible alternative to conventional clinical assessments. The findings of this study are expected to provide important evidence supporting the use of VR technology in clinical practice for the assessment of mobility and balance in older adults.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults | – | Other: Clinical AssessmentsOlder adults undergoing conventional and virtual reality-based assessments of functional mobility, balance, and lower extremity function, including the 4-Meter Walk Test, Five-Times Sit-to-Stand Test, and Timed Up and Go Test, to evaluate validity, reliability, and clinical correlates. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling adults aged 65 years and older who are able to ambulate independently (with or without assistive devices) and can communicate and follow test instructions.
Key inclusion criteria (4 listed)
- Aged 65 years or older,
- Ability to ambulate independently (assistive devices permitted),
- Cognitive ability sufficient to communicate and follow instructions,
- Provision of written informed consent.
Key exclusion criteria (5 listed)
- Acute cardiopulmonary disease,
- Uncontrolled hypertension,
- History of lower extremity surgery or fracture within the past 6 months,
- Severe cognitive impairment preventing cooperation with testing procedures,
- Determination by a healthcare professional that participation is unsafe for safety-related reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical AssessmentsParticipants will perform virtual reality-based adaptations of the 4-Meter Walk Test, Five-Times Sit-to-Stand Test, and Timed Up and Go Test using an immersive virtual reality application developed for the Meta Quest 3 platform. The virtual environment digitally replicates the conventional test setups and protocols, and performance outcomes are automatically recorded by the system. Virtual reality-based assessments will be compared with conventional clinical tests and repeated to evaluate validity, reliability, and clinical correlates. | Other | Older Adults |
Primary outcome
4-Meter Walk Test - Virtual Reality (4MWT-VR)
Time frame: Baseline and 5-7 days
This outcome measure will be used to assess gait speed using a virtual reality-based adaptation of the 4-Meter Walk Test. Walking speed will be automatically calculated by the system. Validity will be evaluated by comparison with the conventional 4-Meter Walk Test, and reliability will be assessed using repeated measurements performed 5-7 days apart.
Five-Times Sit-to-Stand Test - Virtual Reality (5xSTS-VR)
Time frame: Baseline and 5-7 days
This outcome measure will be used to assess lower extremity functional performance using a virtual reality-based adaptation of the Five-Times Sit-to-Stand Test. Test duration will be automatically recorded. Validity and reliability will be evaluated by comparison with the conventional test and repeated measurements.
Timed Up and Go Test - Virtual Reality (TUG-VR)
Time frame: Baseline and 5-7 days
This outcome measure will be used to assess functional mobility using a virtual reality-based adaptation of the Timed Up and Go test. Test completion time will be automatically recorded by the system. Validity and reliability will be examined through comparison with the conventional Timed Up and Go test and repeated measurements.
5 secondary outcomes
4-Meter Walk Test - Conventional
Time frame: Baseline
Five-Times Sit-to-Stand Test - Conventional
Time frame: Baseline
Timed Up and Go Test - Conventional
Time frame: Baseline
Lower Extremity Muscle Strength
Time frame: Baseline
Physical Activity Level (International Physical Activity Questionnaire - Short Form, IPAQ-SF)
Time frame: Baseline
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 23 Jan 2026.
- Background: PubMed 21058606Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
- Background: PubMed 39486588Maden C, Gozacan Karabulut D, Bagci B. Validity and reliability of an immersive virtual reality adaptation of the 6-minute pegboard and ring test. Hand Surg Rehabil. 2025 Feb;44(1):101981. doi: 10.1016/j.hansur.2024.101981. Epub 2024 Oct 30.
- Background: PubMed 24484314Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.
- Background: PubMed 7624188Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
- Background: PubMed 21205966Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- 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.
İsmail ÖZSOY, Assoc. Prof. Dr. study chair
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
Gülşah ÖZSOY, Assist. Prof. Dr. study chair
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
Zehra KORKUT, Assist. Prof. Dr. study chair
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
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 Functional Mobility and Virtual Reality-Based Functional Assessment, run by Selcuk 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 4 inclusion and 5 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 23 Jan 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 Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-Meter Walk Test - Virtual Reality (4MWT-VR) (time frame: Baseline and 5-7 days). The study lists 3 primary outcomes in all. 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 NCT07362212, which also lists 5 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 23 Jan 2026.