An observational study in Chronic Low Back Pain, sponsored by Selcuk University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Selcuk University · Observational
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.
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):
Session 2 (7 ± 2 days later):
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:
o VR-TUG completion time (seconds), including assessment of test-retest reliability across two sessions.
Secondary Outcomes:
ANALYSIS PLAN:
Concurrent validity:
o Correlation between VR-TUG and classic TUG completion times (Pearson or Spearman correlation, depending on data distribution).
Test-retest reliability:
Construct validity:
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.
285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.
This study's planned enrollment of 65 is below the median of 84 across 111 observational studies indexed under Kinesiophobia.
Browse Kinesiophobia studies →Selcuk University is the lead sponsor of 258 studies on the registry; 67 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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Clinically significant
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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).
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.
Time frame: Baseline and 7 ± 2 days (test-retest)
Timed Up and Go (TUG) Completion Time
Time (in seconds) to complete the standard Timed Up and Go test.
Time frame: Baseline
Pain Intensity (Visual Analog Scale, VAS)
Pain intensity measured using a 10-cm visual analog scale (score 0-10).
Time frame: Baseline
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).
Time frame: Baseline
Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)
Fear of movement/(re)injury measured with the Tampa Scale for Kinesiophobia (TSK), Turkish version (score 17-68).
Time frame: Baseline
Test-Retest Reliability of VR-TUG (ICC)
Intraclass correlation coefficient (two-way mixed-effects, single measure) for VR-TUG completion time between baseline and 7 ± 2 days.
Time frame: Baseline and 7 ± 2 days
Agreement and Measurement Error of VR-TUG (SEM/MDC, Bland-Altman)
Standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman agreement analyses for VR-TUG completion time across two sessions.
Time frame: Baseline and 7 ± 2 days
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
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