| CTRI Number |
CTRI/2024/10/074962 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Benefit of Virtual Reality in rehabilitation of patients with chronic vertigo/giddiness |
|
Scientific Title of Study
|
Evaluation of Virtual Reality Assisted Therapy as an Adjunct to Conventional Vestibular Rehabilitation Therapy for Chronic Vestibular Hypofunction: A Randomized Controlled Trial |
| Trial Acronym |
VIRAT (virtual reality assisted therapy) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Upreti |
| Designation |
Assistant Professor, Otorhinolaryngology |
| Affiliation |
All India Institute of Medical Sciences-Rajkot |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Rajkot, Gujarat, India
Rajkot
GUJARAT
360006
India |
| Phone |
9871252109 |
| Fax |
|
| Email |
grmprt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Upreti |
| Designation |
Assistant Professor, Otorhinolaryngology |
| Affiliation |
All India Institute of Medical Sciences-Rajkot |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Rajkot, Gujarat, India
Rajkot
GUJARAT
360006
India |
| Phone |
9871252109 |
| Fax |
|
| Email |
grmprt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhi Patil |
| Designation |
Junior Resident (Academic), Otorhinolaryngology |
| Affiliation |
All India Institute of Medical Sciences-Rajkot |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Rajkot, Gujarat, India
Rajkot
GUJARAT
360006
India |
| Phone |
9764264782 |
| Fax |
|
| Email |
siddhiapatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rajkot,
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not Applicable |
| Type of Sponsor |
Other [None] |
|
|
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 Garima Upreti |
All India Institute of Medical Sciences-Rajkot |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Rajkot, Gujarat, India
Rajkot
GUJARAT |
9871252109
grmprt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H818||Other disorders of vestibular function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional vestibular rehabilitation therapy (VRT) |
Participants allocated to this treatment arm will undergo traditional vestibular rehabilitation therapy, which typically involves a series of exercises based on the principles of habituation, adaptation and substitution designed to promote functional compensation for the vestibular dysfunction.
Participants are expected to attend once a week supervised session of 30 minutes duration each. They are expected to continue the same exercises at their home for atleast 30 minutes duration daily, for a total duration of 6 weeks |
| Intervention |
Virtual Reality Assisted Therapy (VRAT) |
Participants allocated to this treatment arm will receive Virtual Reality (VR) assisted therapy in addition to Conventional VRT. VRAT utilizes immersive virtual reality environments to enhance the effectiveness of vestibular rehabilitation. Participants will engage in customized VR exercises designed to challenge and improve their balance, spatial orientation, and vestibular function. The VR system may include interactive tasks, games, or simulations that simulate real-world environments and activities.
Duration of each session : 30 to 40 minutes of Virtual reality sessions (thrice a week) in addition to supervised conventional vestibular rehabilitation therapy (30 minutes duration once a week)
Frequency of sessions : three sessions per week for a total duration of 6 weeks
This is in addition to the conventional VRT (similar to comparator arm) that they are expected to continue practicing for atleast 30 minutes duration daily for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic vestibular hypofunction:
Duration of vestibular symptoms of 3 months or more
2.Definitive diagnosis of chronic vestibular hypofunction based reduced VOR function documented on one / more of following:
a. VOR gain less than 0.6 on video head impulse test
b. reduced angular VOR gain (less than 0.1) on sinusoidal acceleration on rotary chair testing (0.16Hz), Vmax 50 degrees/second and phase lead more than 68 degrees, time constant less than 5 seconds
c. reduced caloric response, sum of bithermal maximum peak SPV on each side less than 6 degrees/ second, % canal paresis as per Jonkees formula 20% or more |
|
| ExclusionCriteria |
| Details |
1. Use of vestibular suppressants in last 72 hours.
2. Diseases with fluctuating vestibulopathy e.g. Meniere’s Disease
3. Already diagnosed clinical psychiatric conditions/ neurodegenerative/ neuromuscular/
musculoskeletal/ motor disorders/ peripheral neuropathy/ arthropathy in lower
extremities/ uncorrected ocular disorders that will interfere with performance of
rehabilitation exercises
4. Significant medical disorders e.g. severe anaemia, uncontrolled hypertension,
cardiorespiratory disorders, epilepsy, vertebro-basilar insufficiency, cervical spondylosis,
etc. that may be aggravated by exercises.
5. Pregnant females
6. Inability to follow-up |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient reported outcome measures: Dizziness Handicap Inventory (DHI), Activities-specific Balance Confidence Scale (ABC), Vestibular Rehabilitation Benefit Questionnaire (VRBQ), Visual Vertigo Analogue Scale (VVAS)
Clinical assessment tools: Berg Balance Scale, Dynamic Gait Index, Timed up and Go (TUG) test
Objective vestibular testing: Video Head Impulse Test, Rotary chair testing, Bithermal Caloric test, Computerized Dynamic Posturography, Craniocorporography
|
1. Baseline assessment (at presentation)
2. At 6 weeks (at completion of intervention)
3. At 12 weeks (6 weeks post completion of intervention)
4. At 18 weeks (12 weeks post completion of intervention)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [grmprt@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The primary purpose of this study is to evaluate the effectiveness of Virtual Reality Assisted Therapy (VRAT) as an adjunct to Conventional Vestibular Rehabilitation Therapy (VRT) in patients with chronic vestibular hypofunction. The study aims to assess whether the addition of VRAT can enhance treatment outcomes, improve patient compliance, and ultimately lead to a significant improvement in symptoms and quality of life compared to VRT alone. The hypothesis of this study is that the combination of VRAT and VRT will be more effective in reducing symptoms of chronic vestibular hypofunction and improving patient-reported outcomes than VRT alone. Specifically, it is expected that patients receiving both VRAT and VRT will show greater improvements in objective vestibular assessments and patient-reported outcome measures (PROMs) compared to those undergoing conventional VRT alone. |