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

NCT07402499 | Not Yet Recruiting

• 1 other identifier: SU-SBF-FTR-VRTUG-2026-001
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Chronic Low Back Pain

Keywords

Virtual Reality; Timed Up and Go Test; Functional Mobility; Validity; Reliability; Test-Retest; Oswestry Disability Index; Pain Measurement; Kinesiophobia; Tampa Scale for Kinesiophobia

Outcome Measures

Primary Outcomes (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.

  Baseline and 7 ± 2 days (test-retest)

Secondary Outcomes (4)

• Timed Up and Go (TUG) Completion Time

  Baseline

• Pain Intensity (Visual Analog Scale, VAS)

  Baseline

• Disability (Oswestry Disability Index, ODI)

  Baseline

• Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)

  Baseline

Other Outcomes (2)

• Test-Retest Reliability of VR-TUG (ICC)

  Baseline and 7 ± 2 days

• Agreement and Measurement Error of VR-TUG (SEM/MDC, Bland-Altman)

  Baseline and 7 ± 2 days

Study Arms (1)

Chronic Non-Specific Low Back Pain Group

Adults 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).

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Konya, 42130, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  BACKGROUND

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  PMID: 15129077 BACKGROUND

• 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.

  PMID: 38383819 BACKGROUND

• 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.

  PMID: 36118569 BACKGROUND

• 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.

  PMID: 32168361 BACKGROUND

• 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.

  PMID: 34640491 BACKGROUND

• 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.

  PMID: 41204536 BACKGROUND

• 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.

  PMID: 24132792 BACKGROUND

• 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.

  PMID: 38866224 BACKGROUND

• 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.

  PMID: 35635989 BACKGROUND

• 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.

  PMID: 25497269 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 27745712 BACKGROUND

• 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.

  PMID: 30546064 BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Central Study Contacts

Mehmet Akif Güler, PhD

CONTACT

+90 542 464 42 09; makif.guler@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: March 21, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified IPD and supporting documents will be available after publication of the primary outcome results and will remain available for 3 years thereafter.
• Access Criteria: De-identified IPD will be made available to qualified researchers upon reasonable request. Requests must include a methodologically sound proposal and will be reviewed by the study team. Data sharing will comply with institutional and ethical guidelines, and a data use agreement may be required.

Locations

TU (1)