| CTRI Number |
CTRI/2024/09/073266 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [VIRTUAL REALITY BASED VESTIBULAR REHABILITATION THERAPY] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to find whether use of virtual reality based treatment for vestibular disease is superior to home based rehabilitation exercises or both are equally effective |
|
Scientific Title of Study
|
Virtual reality based vestibular rehabilitation therapy versus home based
rehabilitative exercises in patients of Vestibular Neuritis -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 |
Bannya Roy |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department Of Otorhinolaryngology, Golden Jubilee Block, Armed Forces Medical College, Wanowarie Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7769985804 |
| Fax |
|
| Email |
danrithgeraldeline@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Raj |
| Designation |
Prof & Hod, Dept Of Otorhinolaryngology |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Department Of Otorhinolaryngology, Golden Jubilee Block, Armed Forces Medical College, Wanowarie Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9958414385 |
| Fax |
|
| Email |
poonam_mehra13@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Raj |
| Designation |
Prof & Hod, Dept Of Otorhinolaryngology |
| Affiliation |
Armed Forces Medical College |
| Address |
Department Of Otorhinolaryngology, Golden Jubilee Block, Armed Forces Medical College, Wanowarie Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9958414385 |
| Fax |
|
| Email |
poonam_mehra13@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College
Wanowrie, Pune-411040
|
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Solapur Road, Wanowrie, Near Race Course, Pune-411040 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bannya Roy |
Command Hospital Southern Command |
ENT OPD, Civil OPD Complex,Command Hospital, Wanowarie Pune 411040
Pune
MAHARASHTRA |
7649901960
danrithgeraldeline@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H812||Vestibular neuronitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cawthorne Cooksey exercises |
Patients Will Be Advised To Perform These Exercises At Home And Review After 04 Weeks |
| Intervention |
Virtual Reality Based Vestibular Rehabilitation Therapy |
Patients will be subjected to virtual reality based vestibular rehabilitation module (Neuroequilibrium) for 02 sessions per week, each session lasting 30 minutes for a total of 08 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS 18 YEARS AND ABOVE REPORTING TO COMMAND HOSPITAL PUNE ENT OPD AND DIAGNOSED AS VESTIBULAR NEURITIS |
|
| ExclusionCriteria |
| Details |
Musculoskeletal disorders
Any ocular abnormalities
Any diagnosed neurological disorder Treatment with anticonvulsant, antidepressant, hypnotic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Dizziness Handicap Inventory(DHI) score |
Initial DHI score at day 7 of initial presentation, followed by repeat DHI after 30 days of initial scoring. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
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. |