Investigation of the Effects of Virtual Reality-Based Rehabilitation on Muscle Architecture, Balance Control, and Patient Satisfaction in Individuals With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Limits of Stability (mm/°/s)
研究概览
简要总结
Chronic low back pain is a common musculoskeletal disorder that causes pain, disability, and reduced quality of life. It is often related to changes in trunk muscle function, thoracolumbar fascia morphology, and impaired balance control. Although conventional motor control exercises are effective, patient motivation and adherence can be limited. Virtual reality (VR)-based rehabilitation offers interactive and engaging environments that may improve compliance and provide additional therapeutic benefits.
This study is a randomized controlled trial designed to investigate the effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. A total of 40-50 participants aged 18-65 will be recruited and randomly assigned to one of two groups: (1) VR-based rehabilitation or (2) conventional exercise therapy. Both programs will last 8 weeks, delivered three times per week for 40 minutes per session.
The primary outcomes include muscle architecture assessed by ultrasound imaging, thoracolumbar fascia morphology, and postural balance control measured by force platform tests. Secondary outcomes include pain intensity, disability, fear-avoidance beliefs, quality of life, and patient satisfaction.
The findings of this study are expected to provide new insights into the role of VR in rehabilitation and contribute to evidence-based strategies for managing chronic low back pain. By exploring the effects on both physical and patient-reported outcomes, the study may highlight innovative approaches to improve adherence, reduce pain, and enhance daily function in affected individuals.
详细描述
Chronic low back pain is a prevalent musculoskeletal condition associated with altered muscle activation, impaired postural control, and thoracolumbar fascia changes that may contribute to persistent pain and disability. Conventional rehabilitation approaches such as stabilization and motor control exercises are widely recommended, yet patient adherence and motivation often limit their effectiveness.
Virtual reality (VR)-based rehabilitation integrates visual, auditory, and interactive elements that can enhance engagement, provide distraction from pain, and encourage more consistent exercise participation. While VR interventions have shown benefits in populations such as stroke, cerebral palsy, and multiple sclerosis, the evidence in chronic low back pain remains limited.
This randomized controlled trial is designed to investigate the clinical and functional effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. The intervention will combine traditional physiotherapy approaches with VR-based exercises to evaluate potential improvements in muscle architecture, balance control, and patient-centered outcomes such as satisfaction and adherence.
The study will contribute novel data on the feasibility and effectiveness of VR-based rehabilitation in chronic low back pain, with the goal of providing physiotherapists and clinicians with evidence to guide innovative treatment strategies. The adapted approach is expected to promote adherence, improve functional outcomes, and address gaps in the current literature on VR applications in musculoskeletal rehabilitation.
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)
盲法说明
Participants will be randomized into two groups using a sealed-envelope method: a virtual reality group and a conventional rehabilitation group. The VR group will perform 20 minutes of motor control exercises plus 20 minutes of Pilates-based VR games (5 reps/set), while the control group will complete 40 minutes of progressive motor control/stabilization exercises (10 reps/set). Both groups will train 3 times per week for 8 weeks. Ultrasound imaging assessments will be performed by an experienced physiotherapist who will remain blinded to group allocation. This ensures that outcome assessment of muscle architecture is conducted under blinded conditions. Participants and care providers will not be blinded due to the visible nature of the interventions. Evaluations at baseline, 8 weeks, 3 and 6 months will include ultrasound, balance, pain, disability, and patient satisfaction.
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
- •Age 18-65 years.
- •Chronic low back pain persisting for ≥ 3 months.
- •Literacy and Montreal Cognitive Assessment (MoCA) score >
- •Voluntary participation with signed informed consent.
排除标准
- •Malignancy.
- •Pregnancy.
- •History of epilepsy (including photosensitive seizures), dementia, migraine, or other neurological disorders limiting VR use.
- •Surgery within the past 6 months.
- •Received physiotherapy or rehabilitation services in the past 6 months.
- •Presence of acute infection.
- •Unhealed fracture.
- •Withdrawal of informed consent at any stage of the study.
结局指标
主要结局
Change in Limits of Stability (mm/°/s)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Maximum excursion, reaction time, movement velocity, and directional control measured by force platform (Freemed, Sensor Medica).
Change in Internal Oblique Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position
Change in External Oblique Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position
Change in Rectus Abdominis Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position
Change in Thoracolumbar Fascia Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured bilaterally at L3 level in prone position.
Change in Thoracolumbar Fascia Morphology (categorical)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
ssessed bilaterally at L3 level in prone position (regular vs. irregular morphology).
Change in Postural Sway (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Anterior-posterior and medio-lateral sway measured by force platform (Freemed, Sensor Medica).
Change in Transversus Abdominis Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position.
Change in Internal Oblique Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position
Change in External Oblique Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position
Change in Rectus Abdominis Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured by ultrasound in supine hook-lying position
Change in Thoracolumbar Fascia Thickness (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Measured bilaterally at L3 level in prone position.
Change in Thoracolumbar Fascia Morphology (categorical)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
ssessed bilaterally at L3 level in prone position (regular vs. irregular morphology).
Change in Postural Sway (mm)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Anterior-posterior and medio-lateral sway measured by force platform (Freemed, Sensor Medica).
Change in Limits of Stability (mm/°/s)
时间窗: Baseline, 8 weeks, 3 months, 6 months.
Maximum excursion, reaction time, movement velocity, and directional control measured by force platform (Freemed, Sensor Medica).
次要结局
- Pain Intensity(Baseline, 8 weeks, 3 months, 6 months.)
- Functional Disability(Baseline, 8 weeks, 3 months, 6 months.)
- Lumbar Paravertebral Muscle Stiffness (N/m)(Baseline, 8 weeks, 3 months, 6 months.)
- Lumbar Paravertebral Muscle Elasticity (ratio)(Baseline, 8 weeks, 3 months, 6 months.)
- Trunk Muscle Endurance (mmHg, seconds)(Baseline, 8 weeks, 3 months, 6 months.)
- Fear-Avoidance Beliefs(Baseline, 8 weeks, 3 months, 6 months.)
- Change in Quality of Life (Nottingham Health Profile Total Score)(Baseline, 8 weeks, 3 months, 6 months.)
- Patient Satisfaction(8 weeks, 3 months, 6 months.)
- Exercise Adherence(During the 8-week intervention.)
- Body Composition(Baseline, 8 weeks, 3 months, 6 months.)
研究者
ABDURAHİM ASLIYÜCE
Principal Investigator, Physiotherapist (MSc), Research Assistant, PhD Candidate
Hacettepe University