| CTRI Number |
CTRI/2026/03/105898 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Virtual Reality Balance Training with Head Movements on Dizziness and Vertigo in People with Inner Ear Balance Problems |
|
Scientific Title of Study
|
Effect of Virtual Reality-Based Vestibular Rehabilitation with Head Movements on Dizziness Severity and Vertigo Symptoms in Patients with Unilateral Peripheral Vestibular Dysfunction: A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaitali Patil |
| Designation |
PG Student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9834541953 |
| Fax |
|
| Email |
chaipatil2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9867631730 |
| Fax |
|
| Email |
tkulkarni1110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
9867631730 |
| Fax |
|
| Email |
tkulkarni1110@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai, Maharashtra,India - 410210 |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai, Maharashtra,India - 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai, Maharashtra,India - 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chaitali Patil |
TMVs Lokmanya Tilak College of Physiotherapy |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai, Maharashtra,India - 410210
Raigarh
MAHARASHTRA |
9834541953
chaipatil2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee (Academics) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Virtual Reality–Based Vestibular Rehabilitation with Head Movements |
Participants will undergo virtual reality–based vestibular rehabilitation with head movements using VR goggles with the VR Roller Coaster application. The rehabilitation program will be administered for a duration of 4 weeks. Outcome measures including the Dizziness Handicap Inventory (DHI) and Vertigo Symptom Scale – Short Form (VSS-SF) will be assessed at baseline, 2 weeks, and 4 weeks to evaluate changes in dizziness severity and vertigo symptoms. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 30–60 years
2. Positive findings on relevant clinical tests, from ENT specialist.
3. Clinically diagnosed vertigo with chronic unilateral peripheral vestibular dysfunction .
4. Mild to moderate vertigo and dizziness symptoms, as measured by the Dizziness Handicap Inventory (DHI)scale.
5. Patient able to understand and follow instructions.
6. Patient currently not on medications (chronic patients). |
|
| ExclusionCriteria |
| Details |
1. Patients who cannot tolerate virtual reality due to physical or health limitations.
2. Patients with a positive Dix-Hallpike test (indicating Benign Paroxysmal Positional Vertigo [BPPV]). This is because BPPV has specific treatments (e.g. repositioning maneuvers).
3. Contraindications to Virtual Reality (VR) use, such as:
•Severe visual impairments (Nystagmus, Double vision, cataracts, photosensitivity).
•Severe motor impairments affecting VR engagement.
4. Severe dizziness symptoms in patients that prevent safe participation in therapeutic exercises.
5. Central vestibular disorders like vestibular migraines
6. Severe cognitive impairments that hamper the ability to understand or perform the intervention protocols. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dizziness Handicap Inventory (DHI) |
Baseline, 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vertigo Symptom Scale – Short Form (VSS-SF) |
Baseline, 2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
22/03/2026 |
| 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="0"
Months="1"
Days="15" |
|
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
|
This pilot study aims to evaluate the effect of virtual reality–based vestibular rehabilitation with head movements on dizziness severity and vertigo symptoms in patients with unilateral peripheral vestibular dysfunction. Participants diagnosed with unilateral peripheral vestibular dysfunction will perform head movements using VR goggles with the VR Roller Coaster application, progressing from sitting in week 1, standing in week 2, standing on uneven ground in week 3, and continuing at the same highest challenge level in week 4. The rehabilitation program will be conducted for a duration of 4 weeks with each session consisting of 10 minutes of VR exposure plus a 5-minute interval for 2 sets, 4 sessions per week. Dizziness, vertigo symptoms, and quality of life will be assessed using the Dizziness Handicap Inventory and Vertigo Symptom Scale Short Form at baseline, two weeks, and four weeks. |