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临床试验/NCT06030960
NCT06030960已完成不适用

The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain

Imam Abdulrahman Bin Faisal University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Postural stability

研究概览

简要总结

To our knowledge, no studies have better investigated the effect of Core Stabilization Exercises using VR on ankle and trunk proprioception in patients with CLBP and in turn on postural stability.

详细描述

Background: Low Back Pain (LBP), one of the most critical disability causatives, has been associated with neuromuscular and biomechanical manifestations related to the deficiency of postural control and stability. Virtual reality (VR) core stabilization exercises (CSE) has proven previously to be effective in improving postural control among conditions with different proprioceptive damage mechanisms other than those affected with LBP. The Aim of this study is to explore the differing effects of this treatment regimen on postural stability in relation to lumbar and ankle proprioception in a population of participants with LBP. Design and Methods: a randomized clinical trial encompassing 44 participants of both genders. Participants with Chronic Low Back Pain (CLBP) will be randomized to one of two treatment groups: an Experimental group receiving VR stabilization exercises and a Control group receiving CSE only without VR simulations inaddition to patient instructions and education of both groups. Parameters of postural stability, ankle and trunk proprioception, pain intensity, balance interference with activity and psychological aspects of pain interference with activity will be measured by a force plate, iPhone applications, visual analog scale (VAS), the Activities-specific Balance Confidence (ABC) scale, Pain Catastrophizing Scale (PCS) and the Pain Self-Efficacy Questionnaire (PSEQ-Ar) respectively. Outcome measures will be collected at baseline, immediately after 1st treatment and after the last treatment session. Treatment regimens will consist of 12 sessions in 3 weeks using virtual reality glasses. Statistical Analysis: A linear mixed model will be used to analyze within- and between-group differences at the baseline, 6th session and twelfth sessions (repeated measures will be set as GROUP with two levels and TIME with three levels). Bonferroni post-hoc procedures will be used for multiple comparisons of the differences over time. Intention-to-treat analysis shall be utilized. Statistical significance was set at P < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients in Group 1 and Group 2 will be included if they:
  • •Are adults between 25 and 59 years of age.
  • •Have LBP for longer than 3 months.
  • •Are not currently undergoing medication or conservative treatment.

排除标准

  • •Patients in these two groups will be excluded if they have:
  • •Nerve root manifestations (such as referred symptoms of radiating pain below the knee or paresthesia during the straight leg raise test),
  • •Systematic or visceral disease,
  • •Ankylosing spondylitis, Spondylolysis and Spondylolisthesis,
  • •Vestibular dysfunctions,
  • •Body mass index (BMI) ≥ 30 kg/m2,
  • •Lower extremity injury within the past month,
  • •Concussion,
  • •Psychiatric, cardiovascular or musculoskeletal disorders,
  • •Vision problems,
  • •Vertebral fracture,
  • •Spinal Stenosis,
  • •Previous spinal surgery,
  • •Present pregnancy,
  • •Inability to understand instructions, read or write (Li et al., 2021).

研究组 & 干预措施

Group 1

Experimental

Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education

干预措施: Virtual Reality (VR) (Device)

Group 1

Experimental

Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education

干预措施: Regular Exercises (Other)

Group 1

Experimental

Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education

干预措施: patient instructions and education (Other)

Group 2

Active Comparator

Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education

干预措施: Regular Exercises (Other)

Group 2

Active Comparator

Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education

干预措施: patient instructions and education (Other)

结局指标

主要结局

Postural stability

时间窗: 12 weeks

Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):

Proprioception

时间窗: 12 weeks

Ankle and Trunk Joint Position Sense (JPS)

次要结局

  • Pain Intensity(12 weeks)
  • Pain Self-Efficacy Questionnaire (PSEQ-Ar)(12 weeks)
  • Activities-specific Balance Confidence (ABC)(12 weeks)
  • Pain Catastrophizing Scale(12 weeks)

研究者

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

Abrar AlSadiq

Rehabilitation Sciences PhD Student

Imam Abdulrahman Bin Faisal University

研究点 (1)

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