| CTRI Number |
CTRI/2025/12/099828 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of balance exercises using a mobile phone headset with and without head movements in people with balance problems related to the inner ear |
|
Scientific Title of Study
|
Comparison of the Effectiveness of Virtual Reality Training With and Without Head Movements in Patients With Unilateral Peripheral Vestibular Dysfunction: An Experimental 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
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
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
Raigarh
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 |
|
|
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 |
Third Floor, Department of Neuro Physiotherapy, B Wing, Room No. 303, 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: H813||Other peripheral vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Virtual Reality Training with Head Movements |
Participants will use VR goggles with the VR Roller Coaster application. Head movements will be performed under supervision while sitting in week 1, standing in week 2, and standing on uneven ground in week 3 and continuing at the same highest challenge level in week 4. Sessions will be delivered 4 times per week, each session consisting of 10 minutes of VR exposure with a 5-minute interval repeated for 2 sets. Total duration- 4 weeks. |
| Comparator Agent |
Virtual Reality Training without Head Movements |
Participants will use the same VR goggles with VR Roller Coaster application but will not perform head movements. Sessions will be delivered 4 times per week, each session consisting of 10 minutes of VR exposure with a 5-minute interval repeated for 2 sets.
Total duration-4 weeks |
|
|
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
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dizziness Handicap Inventory |
Baseline, 2 weeks (mid-intervention), 4 weeks (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vertigo Symptom Scale–Short Form |
Baseline, 2 weeks (mid-intervention), 4 weeks (post-intervention) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to compare the effectiveness of virtual reality training with head movements versus without head movements in individuals with unilateral peripheral vestibular dysfunction. Participants will be randomly allocated into two groups. Group A will perform head movements during VR training 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. Group B will perform VR training with the same application but without head movements, following the same session structure. Both groups will undergo supervised four-week interventions, 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. |