| CTRI Number |
CTRI/2024/03/063891 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Virtual Reality therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Virtual reality therapy for vertigo patient |
|
Scientific Title of Study
|
Effectiveness of Virtual Reality Therapy (VRT ) on vertigo
symptoms, bio-physiological Parameters, Functional Level, Coping Strategies
and Quality of Life among patients with Vertigo at a tertiary care hospital, West
Bengal-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 |
VIJAYANANDH M |
| Designation |
PhD. Nursing Scholar |
| Affiliation |
Sri Balaji Vidyapeeth, Puducherry |
| Address |
Room No: 215
Department of ENT-HNS
NH-34, Connector
Basantapur, Saguna, Kalyani
Nadia District
Nadia
WEST BENGAL
741245
India |
| Phone |
9524244889 |
| Fax |
|
| Email |
vijaysbvuscholar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punitha Josephine S |
| Designation |
Principal |
| Affiliation |
Sri Balaji Vidyapeeth Deemed to be University |
| Address |
Room No:03, Principal, Kasturba Gandhi Nursing College.
Sri Balaji Vidyapeeth
(Deemed to Be University)
Pillayarkuppam
Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8940794839 |
| Fax |
|
| Email |
principal@kgnc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
VIJAYANANDH M |
| Designation |
PhD. Nursing Scholar |
| Affiliation |
KGNC, SBVU |
| Address |
Room No 215,
Department of ENT-HNS
NH-34, Connector
Basantapur, Saguna, Kalyani
Nadia District
Nadia
WEST BENGAL
741245
India |
| Phone |
9524244889 |
| Fax |
|
| Email |
vijaysbvuscholar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Kalyani, West Bengal |
|
|
Primary Sponsor
|
| Name |
VIJAYANANDH M |
| Address |
KGNC, SBVU Campus, Cuddalore-Puducherry ECR, Pillayarkuppam, Puducherry-607402 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ajay Mallick |
All India Institute of Medical Sciences, Kalyani |
Room No: 220
Department of ENT-HNS
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia District
West Bengal
Nadia
WEST BENGAL |
9830033946
ajay.ent@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H811||Benign paroxysmal vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Treatment |
Standard method of Vestibular Rehabilitation |
| Intervention |
Virtual Reality Therapy |
Total Duration of Intervention is 2.5 months. It is the gamification of Vestibular Rehabilitation Exercise |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
canal paresis more than 20 percentage with no other neurological deficit
symptoms of disequilibrium
gait instability
spinning /dizziness
or motion sensitivity
|
|
| ExclusionCriteria |
| Details |
Patient with Neurological Disorders (eg. Migraines vertigo)
Patient with any other Movement Disorders (eg. tic., dystonia)
Patient who is unable to follow the Virtual reality therapy
Previous vestibular rehabilitation or have bilateral peripheral vestibular pathology
Patients with mental incompetence.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients may have reduced or no vertigo symptoms |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients will have reduced or no vertigo symptoms that will bring improvement in their daily activities, quality of life,functional ability. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
20/03/2024 |
| 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="0"
Days="0" |
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)
|
"Vertigo, a common vestibular disorder, presents with sensations of dizziness and spinning, often accompanied by imbalance. Its prevalence varies globally, affecting around 15% of the world’s population and approximately 0.71% in India, with a higher incidence in women and older adults. Diagnosing vertigo involves differentiating it from other forms of dizziness through physical exams and medical history assessments. Treatments like vestibular rehabilitation therapy (VRT) offer promising outcomes, especially for conditions like benign paroxysmal positional vertigo (BPPV). This RCT study will help to determine how Virtual Reality Therapy (VRT) is effective in reducing or eliminating vertigo symptoms and indirectly will assess their quality of life, functional impairment, coping strategies, and bio-physiological parameters before and after intervention. This marks a state-of-the-art approach in the treatment of vertigo." |