Selcuk University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Konya, 42130, Turkey (Türkiye)
Location contact
Mehmet A Güler, PhD
PRINCIPAL_INVESTIGATOR
Mehmet Akif Güler, PhD
CONTACT
NCT Number: NCT07402499
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Observational
Konya, 42130, Turkey (Türkiye)
Mehmet A Güler, PhD
PRINCIPAL_INVESTIGATOR
Mehmet Akif Güler, PhD
CONTACT
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:
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:
o VR-TUG completion time (seconds), including assessment of test-retest reliability across two sessions.
ANALYSIS PLAN:
o Correlation between VR-TUG and classic TUG completion times (Pearson or Spearman correlation, depending on data distribution).
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 7 ± 2 days (test-retest)
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
Time (in seconds) to complete the standard Timed Up and Go test.
Time frame: Baseline
Pain intensity measured using a 10-cm visual analog scale (score 0-10).
Time frame: Baseline
Self-reported disability related to low back pain measured with the Oswestry Disability Index (ODI), Turkish validated version (score 0-100).
Time frame: Baseline
Fear of movement/(re)injury measured with the Tampa Scale for Kinesiophobia (TSK), Turkish version (score 17-68).
Time frame: Baseline and 7 ± 2 days
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
Standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman agreement analyses for VR-TUG completion time across two sessions.
Contact information is provided by the study sponsor or research team.
Selcuk University
Other
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
Acronym: VRTUG-CLBP
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