Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Headache Impact Scale (HIT-6):
研究概览
简要总结
The study will be conducted on patients diagnosed with UVH who apply to Prof. Dr. Mete İşeri Ear, Nose and Throat Diseases Polyclinic and Güneşli Erdem Hospital Ear, Nose and Throat and Vestibular Rehabilitation Unit. Participants will be divided into 3 groups by simple randomization (closed envelope) method. To the vestibular rehabilitation group; A conventional rehabilitation program based on structured Cawthorne Cooksey exercises will be applied for 45 minutes once a week with the support of a physiotherapist for 8 weeks. To the optokinetic stimulation group; optokinetic stimulation will be given with virtual reality glasses, and to the combined group; Participants in the vestibular exercise group will receive additional optokinetic stimulation. The application will be done once a week for 8 weeks. Inclusion criteria for the study are; diagnosed with unilateral vestibular hypofunction with VNG test, between the ages of 18-65, class A+ in the System Usability Scale (SUS) and the percentage range being between 96-100%; Exclusion criteria for the study are; Bilateral vestibular hypofunction, visual impairment, neurological disorder and inability to communicate.
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 (Participant)
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
- •Diagnosed with unilateral vestibular hypofunction with VNG test,
- •Being between the ages of 18-65,
- •Being in the A+ class on the System Usability Scale (SCS) and having a value between 96-100 percentile
排除标准
- •Having bilateral vestibular hypofunction
- •Having a visual impairment,
- •Having a neurological disorder
- •Inability to communicate
研究组 & 干预措施
Group 1 (VR Group)
Participants will receive a structured conventional vestibular rehabilitation program for eight weeks, once a week, in 45-minute sessions supervised by a physiotherapist. The program will be individualized based on Cawthorne-Cooksey exercises and progressively advanced with the guidance of a vestibular therapist. Additionally, participants will be provided with a home exercise program, to be performed twice daily (morning and evening), with 10 repetitions each time.
干预措施: Conventional rehabilitation program based on Cawthorne Cooksey exercises (Other)
Group 2 (OKS Group)
Optokinetic stimulation sessions are planned with a balloon rotation speed of 20°/s (degrees per second) during the first four weeks. In the fifth and sixth weeks, the speed will be increased to 25°/s, and in the seventh and eighth weeks, it will be raised to 30°/s. The background screen will be set to rotate in the same direction as the balloons, with a rotation speed equal to 30-50% of the balloon rotation speed. The visual stimulus scene will feature colorful balloons moving in circular patterns, both clockwise and counterclockwise. Participants will be instructed to focus on a red balloon within the scene. The initial session duration will be set at 30 seconds and will be gradually increased up to 150 seconds depending on the participant's tolerance. Each session will include three repetitions of optokinetic stimulation.
干预措施: Optokinetic Virtual Reality Stimulation (Other)
Group 3 (VR+OKS Group)
Participants in this group will receive both the vestibular rehabilitation program and the optokinetic stimulation described above. Both interventions will be administered simultaneously over an 8-week period, in accordance with the respective protocols.
干预措施: VR+OKS (Other)
结局指标
主要结局
Headache Impact Scale (HIT-6):
时间窗: 8 Weeks
Bayliss et al. It is a short questionnaire designed to assess migraine pain from the patient's perspective and track lost time. Each item is answered using a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The final score is determined from the sum of 6 items with a range from 36 to 78. Higher scores indicate greater impact.
Motion Sickness Severity Scale (MSSS)
时间窗: 8 Weeks
It is a 7-point scale rated from 0 to 6, where participants select the item that best describes their current condition: none (0), stomach awareness or discomfort (1), mild nausea (2), moderate nausea (3), severe nausea (4). ), gagging (5) or vomiting (6).
Simulator Sickness Survey (SHA)
时间窗: 8 Weeks
It has been widely used to evaluate various forms of disease triggered by virtual environments. 16 symptoms such as eye fatigue, nausea, sweating and headache are evaluated in 4 different severity levels (0: none, 1: mild, 2: moderate and 3: severe). Symptoms are grouped into 3 non-mutually exclusive categories representing nausea, oculomotor disturbance, and disorientation. Higher scores in each category indicate stronger perceptions of underlying disease symptoms. A total score above 20 is considered "poor-failing".
次要结局
- Fatigue Severity Scale (FSS)(8 Weeks)
- Dizziness Handicap Inventory (DHI)(8 Weeks)
研究者
Ebru Sever
Specialist Physiotherapist
Medipol University