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临床试验/CTRI/2024/09/073266
CTRI/2024/09/073266进行中(未招募)不适用

Virtual reality based vestibular rehabilitation therapy versus home based rehabilitative exercises in patients of Vestibular Neuritis -a Randomized Controlled Trial

Armed Forces Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Change in Dizziness Handicap Inventory(DHI) score

研究概览

简要总结

VIRTUAL REALITY BASED VESTIBULAR REHABILITATION THERAPY VS HOME BASED REHABILITATIVE EXERCISES- A RANDOMIZED CONTROLLED TRIAL

After obtaining institutional ethical committee approval, patients aged 18 yrs and above attending ENT OPD and diagnosed as Vestibular Neuritis will be included in the study. The patients and their parents/guardian will be counselled about their participation in the study and informed consent will be taken as per Consent Form (Appendix A).  All patients will be given medical management (Corticosteroids and vestibular sedatives) for 07 days prior to rehabilitation. 40 patients will be selected and divided into two groups (group A and group B) by simple random sampling. Each group will be assessed using Dizziness Handicap Inventory to obtain baseline values following conclusion of medical management (Appendices B & C). Group A with 20 patients will undergo VR based vestibular rehabilitation therapy (twice a week) and group B consisting of 20 patients will be taught home based rehabilitative exercises and will also be called to OPD twice weekly for follow up. Patients from both groups will be assessed for symptomatic improvement after 01 month again by using DHI and scores in both groups will be compared using student’s unpaired t test.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ALL PATIENTS 18 YEARS AND ABOVE REPORTING TO COMMAND HOSPITAL PUNE ENT OPD AND DIAGNOSED AS VESTIBULAR NEURITIS.

排除标准

  • Musculoskeletal disorders Any ocular abnormalities Any diagnosed neurological disorder Treatment with anticonvulsant, antidepressant, hypnotic agents.

结局指标

主要结局

Change in Dizziness Handicap Inventory(DHI) score

时间窗: Initial DHI score at day 7 of initial presentation, followed by repeat DHI after 30 days of initial scoring.

次要结局

未报告次要终点

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Bannya Roy

Armed Forces Medical College

研究点 (1)

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