Effect of Virtual Reality-Based Rehabilitation on Balance, Pain, Kinesiophobia, Depression, and Quality of Life in Individuals With Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
This study aims to evaluate the effects of incorporating virtual reality (VR) therapy into routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals diagnosed with lumbar disc herniation (LDH).
详细描述
Purpose:
The purpose of this study is to evaluate the effects of adding virtual reality (VR) therapy to routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals with lumbar disc herniation (LDH).
Methods:
A total of 93 patients diagnosed with LDH will be randomly assigned into two groups: an intervention group (n=47) and a control group (n=46). Both groups will undergo a conventional physical therapy program consisting of transcutaneous electrical nerve stimulation (TENS), vacuum interference, heat application, and ultrasound therapy. In addition to the conventional program, the intervention group will receive VR-based therapy.
Participants will be assessed at baseline and at the end of the intervention period using the following outcome measures: balance assessed by the Nintendo Balance Board-based Balance System; activities of daily living assessed by the Oswestry Disability Index; back pain intensity assessed by the Visual Analog Scale; kinesiophobia assessed by the Tampa Kinesiophobia Scale; quality of life assessed by the Short Form-36 questionnaire; and depression assessed by the Beck Depression Inventory.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lumbar disc herniation (LDH)
- •Sedentary lifestyle
- •Presence of low back pain for at least 3 months
- •No participation in physiotherapy or structured rehabilitation programs within the previous 6 months
排除标准
- •Exclusion Criteria
- •History of spinal surgery or spinal trauma
- •Presence of vestibular disorders
- •Presence of neurological diseases
- •Presence of cardiopulmonary diseases
- •Presence of other musculoskeletal disorders affecting participation
- •Pregnancy
研究组 & 干预措施
Control Group
Arm 1 - Control Group Arm Title: Control Group Arm Type: Active Comparator Description: Participants in this group will receive standard physiotherapy interventions commonly used for the management of lumbar disc herniation.
Intervention Intervention Name: Conventional Physiotherapy Intervention Type: Behavioral Intervention Description: A traditional physiotherapy program including supervised stretching, strengthening, and mobility exercises tailored for individuals with lumbar disc herniation.
Assigned Arm: Control Group
干预措施: Conventional Physiotherapy (Other)
Experimental Group
Arm 2 - Experimental Group Arm Title: Experimental Group Arm Type: Experimental Description: Participants in this group will receive a virtual reality-based exercise program designed to improve balance, reduce pain, decrease kinesiophobia, and enhance quality of life.
Intervention Intervention Name: Virtual Reality Exercise Program Intervention Type: Behavioral Intervention Description: A structured virtual reality-based exercise protocol including balance, core-strengthening, mobility tasks, and functional training tailored for lumbar disc herniation.
Assigned Arm: Experimental Group
干预措施: Conventional Physiotherapy (Other)
Experimental Group
Arm 2 - Experimental Group Arm Title: Experimental Group Arm Type: Experimental Description: Participants in this group will receive a virtual reality-based exercise program designed to improve balance, reduce pain, decrease kinesiophobia, and enhance quality of life.
Intervention Intervention Name: Virtual Reality Exercise Program Intervention Type: Behavioral Intervention Description: A structured virtual reality-based exercise protocol including balance, core-strengthening, mobility tasks, and functional training tailored for lumbar disc herniation.
Assigned Arm: Experimental Group
干预措施: VR (Other)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 8 weeks
The ODI is a 10-item questionnaire developed to assess functional impairment in individuals with back pain. It evaluates changes in self-care, lifting, walking, sitting, standing, sleeping, social life, travel, and pain. Each item is scored from 0 to 5, with the total score ranging from 0 to 50. The total score is then multiplied by 2 and expressed as a percentage, with higher scores indicating greater disability
SF-36 Quality of Life Scale
时间窗: 8 weeks
The SF-36 assesses quality of life across eight domains: physical functioning, bodily pain, general health perception, vitality, mental health, social functioning, and physical and emotional roles. Its validity and reliability in Turkey were established by Pınar et al.
Tampa Kinesiophobia Scale (TSK)
时间窗: 8 weeks
The TSK is a 17-item self-report questionnaire using a 4-point Likert scale to assess fear of movement and/or reinjury. Total scores are calculated by reverse-scoring items 4, 8, 12, and 16, with possible scores ranging from 17 to 68. Scores of 37 or higher indicate a high level of kinesiophobia
Beck Depression Inventory (BDI)
时间窗: 8 weeks
The Beck Depression Inventory (BDI) is a 21-item self-report Likert-type scale used to determine the frequency of depressive symptoms. Items are scored from 0 to 3, and the scale's validity and reliability in Turkey were established by Ulusoy et al.
次要结局
未报告次要终点