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临床试验/NCT07402499
NCT07402499尚未招募不适用

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

Selcuk University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2026年3月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
65
试验地点
1
主要终点
Virtual Reality Timed Up and Go (VR-TUG) Completion Time

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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).

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Akif Guler

Lecturer Dr.

Selcuk University

研究点 (1)

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