| 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. |
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H813||Other peripheral vertigo, |
|
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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. |
|
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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. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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) |
|
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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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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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