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临床试验/NCT06967077
NCT06967077尚未招募不适用

Exploring the Feasibility and Acceptability of Virtual Reality Exercise for Pain Management, Fear of Movement, Mobility, and Proprioception Deficit in Axial Spondyloarthritis Patients During Flares: Twics Design

University of Bath0 个研究点目标入组 40 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
1. Change in spinal mobility

研究概览

简要总结

Axial spondyloarthritis (axSpA) is an autoimmune disease that causes inflammatory arthritis of the spine, causing pain, stiffness, and mobility limitations. During flares, when symptoms worsen, people with axSpA often experience increased pain and difficulty moving, making daily activities more challenging. This study aims to explore whether virtual reality (VR) exercise can help manage pain, improve movement, and support rehabilitation for axSpA patients during flares.

Participants will use a VR system to perform gentle exercises designed to encourage movement and reduce discomfort. Their spinal mobility will be measured using motion capture technology, and their experiences with VR will be assessed through questionnaires and interviews.

This research will help determine whether VR can be a practical and beneficial tool for axSpA rehabilitation, potentially offering a new way to manage symptoms and improve quality of life. The findings will guide future studies on using VR in healthcare settings for people with chronic pain conditions.

详细描述

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting the spine and sacroiliac joints, causing pain, stiffness, and reduced mobility. Flares are periods of increased disease activity, which significantly impact patients' ability to move and perform daily tasks, often accompanied by heightened levels of pain and fear of movement, known as kinesiophobia., leading to long-term reductions in mobility and quality of life. Although physical activity is recognized as a valuable self-management tool, some axSpA patients report discomfort or joint injury during exercise, limiting their physical performance.

Additionally, proprioception is often impaired in inflammatory joint diseases, including axSpA. However, proprioception is poorly investigated in axSpA patients. There is a need to better understand mobility and proprioception during and after flares, as this could provide valuable insights for alleviating pain and enhancing functional mobility.

VR systems have shown promise in managing chronic pain and improving physical function through distraction and engaging virtual games. but its feasibility for axSpA patients remains understudied.

Aim:

Evaluate the feasibility of using VR exercises for axSpA patients during flare periods, for pain management, kinesiophobia, mobility improvement, and proprioception impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • Confirmed diagnosis of axial spondyloarthritis (axSpA).
  • Experiencing an active flare of axSpA within the last 6 months
  • Over 18 years of age.

排除标准

  • History of major spinal surgery.
  • Severe vestibular disorders, visual, balance, neurological, or cardiovascular conditions that may affect mobility.

结局指标

主要结局

1. Change in spinal mobility

时间窗: between baseline and one month follow up

Spinal mobility will be assessed using range of motion (ROM) measured via motion capture system.

Change in movement velocity

时间窗: Baseline to one month follow up

Movement velocity of spinal flexion, extension, and rotation will be measured using a motion capture system. Peak angular velocity (degrees/second) will be recorded during standardised movement tasks and compared between baseline and one-month follow-up. Unit of Measure: Degrees/second

Change in kinesiophobia

时间窗: Baseline to one month follow up

Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK). The scale ranges from 17 to 68, with higher scores indicating greater fear of movement. Unit of Measure: TSK score (17-68; higher = worse)

Change in pain intensity

时间窗: Baseline to one month follow up

Pain intensity will be assessed using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, with higher scores indicating greater pain. Change from baseline to follow-up will be analysed. Unit of Measure: VAS score (0-10; higher = worse)

Changes in Pain severity and location

时间窗: Baseline to one month follow up

Pain severity and location will be assessed using the McGill Pain Questionnaire Short Form (MPQ-SF). The scale ranges from 0 to 78, with higher scores indicating greater pain severity. Unit of Measure: MPQ-SF score (0-78; higher = worse)

proprioception impairment

时间窗: from baseline to one month follow up.

Changes in JPE scores between flare and non-flare stages to determine proprioception impairments Joint Position Error (JPE) will be measured using a spine movement reposition task by asking participants to duplicate angle of movement (for example 45 degree of spine flexion) to assess spine proprioception. Higher JPE scores reflect greater proprioceptive impairment. Unit of Measure: Degrees of deviation from target position Scale Range: 0-180 degrees (theoretically depends on direction of movement); lower scores indicate better proprioception

Change in spinal flexibility

时间窗: Baseline to one month follow up

Spinal flexibility will be measured using the Bath Ankylosing Spondylitis Metrology Index (BASMI). The scale ranges from 0 to 10, with higher scores indicating worse spinal mobility. Unit of Measure: BASMI score (0-10; higher = worse)

Change in Disease Activity

时间窗: Baseline to one month follow up

Improvement in disease activity assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Change in Functional Limitation

时间窗: from baseline to one month follow up.

Improvement in functional limitation as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) and its correlation with objective movement parameters. BASFI (0-10 scale): Higher scores indicate worse functional limitation.

Usability of VR rehabilitation

时间窗: from baseline to one month follow up.

Usability will be assessed using the System Usability Scale (SUS). SUS: A 10-item scale with scores ranging from 0 to 100. Higher scores indicate better usability. Unit of Measure: SUS score (0-100)

Motion Sickness Symptoms During VR Use

时间窗: Baseline to one month follow up

motion sickness, will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ). VRSQ: Includes multiple subscales measuring symptoms such as oculomotor strain and disorientation. Higher scores indicate greater motion sickness symptoms. Unit of Measure: VRSQ subscale scores

Acceptability of VR Rehabilitation

时间窗: Baseline to one month follow up

Acceptability will be assessed through semi-structured interviews exploring participants' experiences, perceived benefits, barriers to use, and overall views on the intervention. Unit of Measure: Qualitative themes derived from participant interviews

次要结局

未报告次要终点

研究者

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

Alaa Jamil Kattan

Principal Investigator (PhD student)

University of Bath

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