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CTRI Number  CTRI/2026/01/102633 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 26/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This study helps in assessing the effectiveness of using a treatment based on computer generated environment in addition to regular home based physical treatment to treat the dizziness and balance problems caused by an underperforming inner ear. 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madumithaa K 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  ENT OFFICE, Old hospital block, JIPMER hospital,
ENT OFFICE, Old hospital block, JIPMER hospital,
Pondicherry
PONDICHERRY
605006
India 
Phone  9585252618  
Fax    
Email  madumithaakishore@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKalaiarasi raja 
Designation  Additional Professor 
Affiliation  JIPMER 
Address  ENT OFFICE, Old hospital block, JIPMER hospital

Pondicherry
PONDICHERRY
605006
India 
Phone  9489693249  
Fax    
Email  kalaiarasi004@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKalaiarasi raja 
Designation  Additional Professor 
Affiliation  JIPMER 
Address  ENT OFFICE, Old hospital block, JIPMER hospital

Pondicherry
PONDICHERRY
605006
India 
Phone  9489693249  
Fax    
Email  kalaiarasi004@gmail.com  
 
Source of Monetary or Material Support  
JIPMER,Puducherry 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MadumithaaK  JIPMER  ENT OFFICE, DEPT OF ENT, OLD HOSPITAL BLOCK
Pondicherry
PONDICHERRY 
9585252618

madumithaakishore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-INTERVENTIONAL STUDIES,JIPMER,PUDUCHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H813||Other peripheral vertigo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Home based vestibular rehabilitation exercises  The exercises prescribed and demonstrated will be performed by patients regularly at home for a period of 8 weeks 
Intervention  Virtual reality based vestibular rehabilitation therapy   Participants 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.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age between 18 and 65 years.
Diagnosis of PVH confirmed by VNG showing canal paresis with directional preponderance. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of supplementing Virtual reality based Vestibular rehabilitation therapy with home based Vestibular rehabilitation exercises on dizziness symptoms when compared to the Home based vestibular rehabilitation exercises alone among the patients with peripheral vestibular hypofunction.  Baseline ,4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient tolerance and adherence to Virtual reality based VRT using Simulator sickness questionnaire(SSQ) survey among the patients with Peripheral Vestibular Hypofunction.  After 1st and last session.(4 weeks) 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   07/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.

 
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