Modern Diagnostic Methods and Evaluation of Rehabilitation Effects Using Virtual Reality (VR) Therapy for Patients With Cervical Spine Discopathy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.
研究概览
简要总结
The study will assess modern diagnostic methods and evaluate the rehabilitation effects of virtual reality (VR) therapy in patients with cervical spine discopathy.
详细描述
Study Design and Group Composition:
The study will involve 100 patients with cervical spine discopathy participating in a rehabilitation program at the Provincial Hospital in Tarnów, Poland.
Eligible patients will be randomly assigned to one of two groups:
Study Group (50 patients): Participants will undergo a standard rehabilitation program supplemented with additional VR therapy aimed at improving the range of motion of the cervical spine.
Control Group (50 patients): Participants will only partake in the standard rehabilitation program.
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Individuals aged 18 to 65 years.
- •Diagnosed and confirmed cervical spine discopathy (ICD-10: M50) through imaging studies (X-ray, MRI).
- •Presence of symptoms related to cervical spine dysfunction, such as neck pain, limited range of motion, and radiating pain to the arms.
- •Informed consent to participate in the study and willingness to adhere to rehabilitation recommendations.
排除标准
- •Active rheumatic diseases, cancers, advanced diabetes, cardiovascular diseases, or other conditions affecting the safety and effectiveness of rehabilitation.
- •Cervical spine surgeries performed within the last 6 months.
- •Cervical spine injuries, including fractures or dislocations.
- •Severe mental disorders.
- •Lack of informed consent to participate in the study.
结局指标
主要结局
Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.
时间窗: Second examination - at the end of the three-week program
Assessment of cervical spine mobility in all planes (flexion, extension, lateral bending, and rotation). Unit of Measure: Range of motion measured in degrees (°), indicating the exact angles of neck movement in each direction. Measurement Tool: The Cervical Range of Motion (CROM) goniometer and Zebris device will be used to measure the exact angles of neck movement with an accuracy of 1°. These tools will evaluate cervical spine mobility across all planes of movement.
Assessment of cervical spine proprioception using virtual reality (VR) goggles.
时间窗: Second examination - at the end of the three-week program
Assessment of deep neck sensation and the ability to perceive the position and movement of the neck. Unit of Measure: Deviation from the intended neck movement measured in degrees (°), which the patient can replicate during proprioceptive tests.Measurement Tool: Virtual Reality (VR) goggles will be the sole tool used to conduct proprioceptive tests. Patients will replicate neck movements displayed in the virtual environment, and the accuracy of these movements will be measured in degrees to assess proprioception and spatial coordination. Method: Using VR goggles to conduct proprioceptive tests, where patients replicate movements shown in the virtual environment to assess their depth perception and spatial coordination.
Assessment of visual field during neck movements using virtual reality (VR) goggles.
时间窗: Second examination - at the end of the three-week program
Measurement of the range of vision while performing neck movements, with the patient seated and looking straight ahead. Unit of Measure: Range of vision measured in degrees (°), indicating the extent to which the patient can perceive moving objects in different parts of their visual field while maintaining a forward gaze. Measurement Tool: Virtual Reality (VR) goggles will be used to track and analyze the patient's ability to follow moving objects across their visual field while sitting and looking straight ahead. The visual range will be measured in degrees to assess the field of vision during neck movements without changing the direction of the gaze
次要结局
- Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).(Second examination - at the end of the three-week program)
- Assessment of functional improvement in daily activities and overall functionality using the Neck Disability Index (NDI) questionnaire.(Second examination - at the end of the three-week program)
- Quality of life assessment using the SF-20 Health Survey questionnaire.(Second examination - at the end of the three-week program)
研究者
Andżelina Wolan-Nieroda
Principal Investigator
University of Rzeszow