The efficacy of virtual reality based vestibular rehabilitation therapy as an add on therapy on dizziness symptoms among the patients with peripheral vestibular hypofunction - A randomized controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
In this randomized controlled trial, after approval from PGRMC, Institute Ethics Committee, patients coming to ENT Outpatient Department fulfilling the inclusion and exclusion criteria will be included in the study.
The patients aged 18 to 65 years and diagnosed with Peripheral Vestibular Hypofunction based on clinical history and findings from videonystagmography and bithermal water caloric tests will be recruited from ENT OPD and ENT vertigo clinic.
Participants will be randomly assigned to one of the two groups using a computer-generated randomization sequence. A third researcher not involved in the day-to-day running of the trial will perform the randomization.
Home-Based VRT group will receive a standardized home exercise program based on the principles of VRT. Patients will be provided instructions for home exercises to manage vertigo.
The exercises will be prescribed and demonstrated, and patients will be instructed to perform them regularly at home. The patients will have weekly follow-up appointments in vertigo clinic to monitor progress and adjust the exercises as needed.
To ensure compliance ,weekly telephonic follow-up will be done with all patients.
The other group will receive a VR based VRT program in addition to the home based exercises using the VR Head mounted display and wireless controllers. The VR software contains a minimum of 10 exercise modules designed for gaze stabilization, sensory reorganization, and head and eye coordination in vertigo patients. The protocol will involve a combination of games focused on attention, gaze stability, postural control, and hand-eye coordination. Patients will attend 2 sessions per week for 4 weeks, for a total of 8 sessions. Each session will last 30-40 minutes and will be supervised by a clinician to ensure safety and correct performance. Exercises will progress from sitting to standing and standing on a foam pad.
Patients in both groups will be evaluated at two time points at baseline and immediately after the 4-week program using the DHI questionnaire.
Dizziness Handicap Inventory which is a 25 item self-report questionnaire to evaluate the patient’s perception of the impact of dizziness on their quality of life. The patient is asked to answer each question as it pertains to dizziness or unsteadiness problem .Questions are designed to incorporate functional physical,and emotional impacts on disability.
Patients tolerance to the VR-based VRT will be assessed at the beginning and last week visit after the exercise session using SSQ to monitor for symptoms like nausea or disorientation. Adherence to the VR based and home-based exercises will be monitored through patient logs or diaries. Number of episodes of attack during the intervention period will also be documented. The SSQ has three categories: nausea, oculomotor, and disorientation. Formulas for scoring each component on the SSQ are proposed. Essentially, each SSQ item can have a score between 0 and 3.. The Simulator Sickness Questionnaire is a 16-item self-report questionnaire designed to assess the side effects of virtual reality, with items rated from 0 to 3 . The total score ranges from 0 to 63, with higher scores indicating more severe symptoms. Three sub-scores calculated: Nausea 7 items, 21 points ,Oculomotor 7 items, 21 points and disorientation7 items,21 points .The SSQ has been widely used to evaluate and reduce simulator sickness. Scores less than 30 are considered as acceptable range. Scores more than 30 are considered as significant scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age between 18 and 65 years.
- •Diagnosis of PVH confirmed by VNG showing canal paresis with directional preponderance.
排除标准
- •Any physical discomfort (e.g., neck discomfort) that would interfere with exercises.
- •Patients having acute episodes History of psychological and/or neurological disorders.
- •Central vestibular pathology.
- •Ischemic heart disease.
研究者
Madumithaa K
JIPMER
