AzTrials
AzTrials

Chronic Low Back PainVRTUG-CLBPNCT07402499

Validation of a Virtual Reality Timed Up and Go Test in Adults With Chronic Non-Specific Low Back Pain

An observational study of Chronic Low Back Pain, run by Selcuk University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study evaluates whether an immersive virtual reality (VR) version of the Timed Up and Go (TUG) test can accurately measure functional mobility in adults with chronic non-specific low back pain. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Chronic Low Back Pain
How many people
65 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Mar 2026to 30 Sep 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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Adults aged 18-55 years with clinician-diagnosed chronic non-specific low back pain who present to the Selcuk University Medical Faculty Physical Therapy and Rehabilitation outpatient clinic and meet the eligibility criteria.

Who may be able to join

  • Age 18 to 55 years.
  • Clinician-diagnosed chronic non-specific low back pain (pain duration ≥ 3 months).
  • Applied to Selcuk University Medical Faculty Physical Therapy and Rehabilitation outpatient clinic with low back pain complaint.
  • Able to walk independently and safely perform the Timed Up and Go (TUG) and VR-TUG tests (with or without usual assistive device).
  • Able to understand and follow instructions; literate in Turkish (at least primary school education).
  • Willing to participate and able to provide written informed consent.

Who cannot join

  • Red flag conditions or suspected specific pathology (e.g., fracture, tumor/metastasis, infection such as spondylitis/discitis).
  • Inflammatory back pain suggestive of conditions such as ankylosing spondylitis or sacroiliitis.
  • Significant radiculopathy or neurological deficit (dermatomal leg pain, marked weakness, reflex changes, sensory loss), clinically significant lumbar disc herniation, severe spinal stenosis, or spondylolisthesis grade II or higher.
  • Prior lumbar spine surgery.
  • Lower-extremity conditions that substantially limit mobility (e.g., severe hip/knee osteoarthritis, hip/knee arthroplasty, amputation, severe deformity).
  • Neurological disorders affecting gait or balance (e.g., stroke, Parkinson's disease, multiple sclerosis, progressive neuromuscular disease).
Show all 12Show fewer
  • Vestibular disorder or recurrent severe vertigo affecting balance.
  • Severe cardiac or pulmonary disease that may compromise safety during testing.
  • Pregnancy.
  • Contraindications to VR use (e.g., photosensitive epilepsy) or history of severe VR intolerance (significant nausea, dizziness, visual discomfort, or migraine triggered by VR).
  • Severe cognitive impairment, major psychiatric disorder, or communication problems preventing cooperation.
  • Severe visual or hearing impairment that prevents following instructions or safely using VR.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet Akif Güler, PhD contact

+90 542 464 42 09

makif.guler@selcuk.edu.tr

Turkey (Türkiye)1 site
  • Selcuk University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    Konya, Konya, 42130

    Mehmet Akif Güler, PhD, +90 542 464 42 09, makif.guler@selcuk.edu.tr

    Mehmet A Güler, PhD

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of an Immersive Virtual Reality Adaptation of the Timed Up and Go Test in Individuals With Chronic Non-Specific Low Back Pain

This study evaluates whether an immersive virtual reality (VR) version of the Timed Up and Go (TUG) test can accurately measure functional mobility in adults with chronic non-specific low back pain.

The standard TUG test measures the time needed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. In the VR version (VR-TUG), participants perform the same movements while wearing a VR headset that displays a virtual environment.

Read more

We will examine: (1) whether VR-TUG results are similar to the standard TUG, (2) whether VR-TUG is reliable when repeated about one week later, and (3) whether VR-TUG performance is associated with pain, disability, and fear of movement.

Participants will complete questionnaires (VAS, ODI, and TSK), perform standard TUG and VR-TUG at baseline, and repeat VR-TUG 7 ± 2 days later. Results will help determine whether VR-based functional mobility testing is a practical assessment tool for people with chronic low back pain.

Read the detailed description

BACKGROUND:

Chronic non-specific low back pain (CNSLBP) is a leading cause of disability worldwide. The Timed Up and Go (TUG) test is a valid and reliable measure of functional mobility in individuals with musculoskeletal conditions, including chronic low back pain, and TUG performance has been shown to correlate with pain intensity and disability. Virtual reality (VR) has increasingly been used as a therapeutic intervention for chronic low back pain, but the use of immersive VR as an assessment tool has not been systematically evaluated in this population.

STUDY DESIGN:

This is a prospective, single-center, observational methodological study designed to assess the validity and test-retest reliability of an immersive virtual reality adaptation of the Timed Up and Go test (VR-TUG) in individuals aged 18-55 years with chronic non-specific low back pain.

PROCEDURES:

  • Session 1 (Baseline Assessment):
  • Demographic and clinical data collection
  • Pain intensity (Visual Analog Scale, VAS)
  • Functional disability (Oswestry Disability Index, ODI - validated Turkish version)
  • Kinesiophobia (Tampa Scale for Kinesiophobia - Turkish version)
  • Classic TUG test performance
  • VR-TUG test performance (first measurement)
  • Session 2 (7 ± 2 days later):
  • VR-TUG test performance (second measurement for test-retest reliability)

VR-TUG PROTOCOL:

Participants will wear a head-mounted display (HMD) that presents an immersive virtual environment replicating the spatial parameters of the classic TUG test. They will perform the same sequence of movements (stand up from a chair, walk 3 meters forward, turn 180°, walk back, and sit down) while immersed in the virtual environment. Time to completion will be recorded. A brief familiarization period (approximately 1-2 minutes) will be provided before testing. Participants will be monitored for any adverse effects (such as dizziness, nausea, or visual discomfort), and the VR-TUG will be stopped immediately if needed.

OUTCOME MEASURES:

  • Primary Outcome:
  • VR-TUG completion time (seconds), including assessment of test-retest reliability across two sessions.
  • Secondary Outcomes:
  • Classic TUG completion time (seconds)
  • Pain intensity (VAS)
  • Functional disability (ODI)
  • Kinesiophobia (Tampa Scale for Kinesiophobia)

ANALYSIS PLAN:

  • Concurrent validity:
  • Correlation between VR-TUG and classic TUG completion times (Pearson or Spearman correlation, depending on data distribution).
  • Test-retest reliability:
  • Intraclass correlation coefficient (ICC, two-way mixed-effects model, single measure) for VR-TUG completion time between Session 1 and Session 2.
  • Estimation of standard error of measurement (SEM) and minimal detectable change (MDC).
  • Bland-Altman analysis to evaluate agreement between repeated VR-TUG measurements.
  • Construct validity:
  • Correlations between VR-TUG completion time and clinical measures (VAS, ODI, Tampa Scale for Kinesiophobia). It is expected that longer VR-TUG times will be associated with higher pain, disability, and kinesiophobia scores.

Statistical significance will be set at p < 0.05.

SAMPLE SIZE:

Based on previous studies reporting excellent reliability of technology-supported functional tests in patients with chronic low back pain (ICC ≥ 0.90), a sample size of approximately 65 participants was calculated to detect a correlation of 0.70 between classic TUG and VR-TUG with 90% power and an alpha of 0.05, allowing for potential dropouts.

SAFETY CONSIDERATIONS:

All testing will be conducted in a safe, obstacle-free environment under the supervision of a trained researcher who can provide physical support if needed. Participants will be screened for contraindications to VR use (for example, photosensitive epilepsy or severe motion sickness). Testing will be stopped immediately if participants experience significant discomfort, dizziness, increased pain, loss of balance, or any other adverse effect. All adverse events and reasons for test discontinuation will be recorded.

Keywords
Virtual Reality, Timed Up and Go Test, Functional Mobility, Validity, Reliability, Test-Retest, Oswestry Disability Index, Pain Measurement, Kinesiophobia, Tampa Scale for Kinesiophobia
Medical subject headings
Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07402499
Study groupRoleWhat they receive
Chronic Non-Specific Low Back Pain GroupAdults aged 18-55 years with chronic non-specific low back pain who undergo functional mobility assessment using the Timed Up and Go test and its virtual reality adaptation (VR-TUG).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virtual Reality Timed Up and Go (VR-TUG) Completion Time

    Time (in seconds) to complete the VR-adapted Timed Up and Go test while wearing a head-mounted display, including standing from a chair, walking 3 meters, turning 180°, walking back, and sitting down.

    Measured: Baseline and 7 ± 2 days (test-retest)

Secondary outcomes (4)
  1. Timed Up and Go (TUG) Completion Time

    Time (in seconds) to complete the standard Timed Up and Go test.

    Measured: Baseline

  2. Pain Intensity (Visual Analog Scale, VAS)

    Pain intensity measured using a 10-cm visual analog scale (score 0-10).

    Measured: Baseline

  3. Disability (Oswestry Disability Index, ODI)

    Self-reported disability related to low back pain measured with the Oswestry Disability Index (ODI), Turkish validated version (score 0-100).

    Measured: Baseline

  4. Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)

    Fear of movement/(re)injury measured with the Tampa Scale for Kinesiophobia (TSK), Turkish version (score 17-68).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start21 Mar 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07402499
Sponsor's protocol ID
SU-SBF-FTR-VRTUG-2026-001
Acronym
VRTUG-CLBP
Status last verified
Feb 2026
First submitted
4 Feb 2026
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the primary and secondary outcome results of this study will be shared. This includes the analyzable dataset containing demographic variables, VR-TUG and TUG completion times, pain intensity (VAS), disability (ODI), kinesiophobia scores, and key covariates used in the main analyses.

Publications

  • Tunca, Ö. Y., Yakut, Y., Uygur, F., & Uluğ, N. (2011). Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon, 22(1), 44-49.

  • Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.

    PubMed 15129077
  • Ozsoy G, Aksoy K. Intra- and inter- rater reliability of the face-to-face assessment and tele-assessment of performance-based tests in older adults. Eur Geriatr Med. 2024 Jun;15(3):601-607. doi: 10.1007/s41999-024-00946-7. Epub 2024 Feb 21.

    PubMed 38383819
  • Delbes L, Mascret N, Goulon C, Montagne G. Validation of an immersive virtual reality device accepted by seniors that preserves the adaptive behavior produced in the real world. Front Bioeng Biotechnol. 2022 Sep 2;10:917486. doi: 10.3389/fbioe.2022.917486. eCollection 2022.

    PubMed 36118569
  • Muhla F, Clanche F, Duclos K, Meyer P, Maiaux S, Colnat-Coulbois S, Gauchard GC. Impact of using immersive virtual reality over time and steps in the Timed Up and Go test in elderly people. PLoS One. 2020 Mar 13;15(3):e0229594. doi: 10.1371/journal.pone.0229594. eCollection 2020.

    PubMed 32168361
  • Garay-Sanchez A, Suarez-Serrano C, Ferrando-Margeli M, Jimenez-Rejano JJ, Marcen-Roman Y. Effects of Immersive and Non-Immersive Virtual Reality on the Static and Dynamic Balance of Stroke Patients: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 28;10(19):4473. doi: 10.3390/jcm10194473.

    PubMed 34640491
  • Huang G, Chen W. Therapeutic effects of virtual reality technology on chronic low back pain. Medicine (Baltimore). 2025 Nov 7;104(45):e45867. doi: 10.1097/MD.0000000000045867.

    PubMed 41204536
  • Hirano K, Imagama S, Hasegawa Y, Ito Z, Muramoto A, Ishiguro N. Impact of low back pain, knee pain, and timed up-and-go test on quality of life in community-living people. J Orthop Sci. 2014 Jan;19(1):164-71. doi: 10.1007/s00776-013-0476-0. Epub 2013 Oct 17.

    PubMed 24132792
  • Moreno-Ligero M, Duenas M, Failde I, Del Pino R, Coronilla MC, Moral-Munoz JA. Psychometric Properties of the Pictorial Pain Interference Questionnaire for Assessing Functional Interference in Chronic Low Back Pain. Arch Phys Med Rehabil. 2024 Oct;105(10):1870-1879. doi: 10.1016/j.apmr.2024.05.029. Epub 2024 Jun 10.

    PubMed 38866224
  • Buraschi R, Pollet J, Villafane JH, Piovanelli B, Negrini S. Temporal and kinematic analyses of timed up and go test in chronic low back pain patients. Gait Posture. 2022 Jul;96:137-142. doi: 10.1016/j.gaitpost.2022.05.027. Epub 2022 May 26.

    PubMed 35635989
  • Dobson F. Timed Up and Go test in musculoskeletal conditions. J Physiother. 2015 Jan;61(1):47. doi: 10.1016/j.jphys.2014.11.003. Epub 2014 Dec 10. No abstract available.

    PubMed 25497269
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946
  • Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.

    PubMed 27745712
  • Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.

    PubMed 30546064

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Low Back Pain, 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 6 inclusion and 12 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 11 Feb 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 Akif Güler, PhD (+90 542 464 42 09, makif.guler@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virtual Reality Timed Up and Go (VR-TUG) Completion Time (time frame: Baseline and 7 ± 2 days (test-retest)). 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 NCT07402499, which also lists 14 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 11 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in