Effects of Virtual Reality Motor Control Rehabilitation in Neck Pain Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Neck Disability Index (NDI)
研究概览
简要总结
VR-NECKPAIN is a two-arm, monocentric, single-blind, randomized controlled trial in Neck Pain patients.
The entire treatment consist in 12 sessions, each during 45 minutes, twice a week for 6 consecutive weeks.
Subjects will be evaluated ad baseline (T0) and after six weeks of rehabilitation (T1). There will also be a 3 months Follow-Up assessment (T2).
The total duration of study participation for each subject will be approximately 19 weeks, including evaluation at T0, treatment and evaluation at T1 and T2.
Individuals in the experimental group (VRT) will undergo a virtual reality-based sensorimotor rehabilitation. Control group (CT) subjects will undergo the same rehabilitation of VR subjects, in terms of intensity, time and type, but with the virtual reality turned off.
详细描述
VR-NECKPAIN is a monocentric, single-blind, randomized controlled trial in Neck Pain patients.
Subjects will receive rehabilitation treatment twice a week, for six consecutive weeks. Subjects will be evaluated ad baseline (T0) and after six weeks of rehabilitation (T1). Also there will be a 3 months Follow-Up assessment (T2).
The total duration of study participation for each subject will be approximately 19 weeks, including evaluation at T0, treatment and evaluation at T1 and T2.
Individuals in the experimental group (VRT) will undergo a virtual reality-based sensorimotor rehabilitation. Control group (CT) subjects will undergo the same rehabilitation of VR subjects, in terms of intensity, time and type, but with the virtual reality turned off.
The study is conducted from March 2019 and the conclusion is planned to March 2023.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult individuals (18-70 years old);
- •Neck Pain (Chronic Neck Pain or Whiplash);
- •Normal vision or corrected vision.
排除标准
- •Informed Consent negation;
- •System infection or metabolic/neurological/muscular degenerative disorder;
- •Cervical spinal pathology, fracture or surgery;
- •Radiculopathy;
- •Vestibular impairments;
- •Epilepsy;
- •Pregnancy.
研究组 & 干预措施
Experimental Group (VRT)
Subjects in the experimental group (VRT) will undergo 30 minutes of motor control exercises using a virtual reality-based sensorimotor rehabilitation provided using the Virtual Reality Rehabilitation System (VRRS) of Khymeia Group. The equipment includes a computer workstation connected to a 6 degrees of freedom (DOF) motion-tracking system (Polhemus G4, Vermont, US), a high-resolution LCD displaying the virtual scenarios on a large screen and a software processing the motion data coming: from the receiver of the sensors end-effectors placed on the sternum and on the head through a helmet. The system has been found to reliably record head position and cervical range of motion among asymptomatic people as well as persistent neck pain patients. The VRRS allows the participant to perform the requested motor tasks, while the movement of the system's end-effector is simultaneously represented in a virtual scenario.
干预措施: Virtual Reality Treatment (Other)
Control Group (CT)
Control group (CT) subjects will undergo the same treatment of VRT subjects in terms of intensity, time and type, but with the VR turned off.
干预措施: Control Group (Other)
结局指标
主要结局
Change in Neck Disability Index (NDI)
时间窗: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
The NDI is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The NDI consists of 10 questions in various domains: Pain Intensity, Personal care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping and Recreation. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). Total score is reported on a 0-50 scale.
次要结局
- Change in Numeric Rating Scale (NRS)(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Change in Jerk Movements(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Changes in Joint Position Error (JPE)(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Change in Neck and Pain Disability Scale (NPAD)(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Change in Tampa Scale of Kinesiophobia (TSK)(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Change in Active Range of Motion(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Change in Conjunct Motion(Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
- Patient Global Impression of Change (P-GIC)(Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention))
研究者
Sandro Iannaccone
Principal Investigator
IRCCS San Raffaele