| CTRI Number |
CTRI/2025/07/091049 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
"Study on using Vestibular and Gaze Exercises to Manage symptoms of Motion Sickness"
|
|
Scientific Title of Study
|
Effect of Vestibular Rehabilitation and Gaze Stabilization exercises in individuals with Motion Sickness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Subhasish Chatterjee |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar institute of physiotherapy and rehabilitation |
| Address |
Room NO.6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhasishphysio@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Isha Goel |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room NO.6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8708604458 |
| Fax |
|
| Email |
ishagoel6126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Isha Goel |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar institute of physiotherapy and rehabilitation |
| Address |
Room NO.6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8708604458 |
| Fax |
|
| Email |
ishagoel6126@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room NO.6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana,133207, India |
|
|
Primary Sponsor
|
| Name |
Isha Goel |
| Address |
Maharishi Markandeshwar (Deemed to be university), MMIPR, Mullana , Ambala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Isha Goel |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room NO.6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana,133207, India
Ambala
HARYANA |
8708604458
ishagoel6126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Maharishi Markandeshwar Institute of Medical Sciences and Research, Maharishi Markandeshwar (Deemed to be University) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
Group 1 : vestibular exercises, gaze stabilization exercises and conventional treatment
Group 2 : Vestibular exercises and conventional treatment
Group 3 : Conventional treatment |
Group 1 (Vestibular + Gaze + Conventional):
Comparator Agent – Vestibular exercises + Conventional treatment (Group 2), and Conventional treatment alone (Group 3)
Group 2 (Vestibular + Conventional):
Comparator Agent – Conventional treatment alone (Group 3)
Group 3 (Conventional treatment only):
Comparator Agent – Vestibular + Conventional (Group 2), and Vestibular + Gaze + Conventional (Group 1)
|
| Intervention |
Vestibular exercises and gaze stabilization exercises and conventional treatment |
The intervention will be given in pre and post for 6 weeks
Vestibular exercises:
1.In standing move eyes up and down, slowly and then quickly (2 minutes) then move eyes to left and right, slowly and then quickly (2 minutes).
2.Stand with one arm elevated over the head, with the eyes looking at the elevated hand. Bend over and low the arm diagonally with the eyes continuously looking at the hand until the hand arrives at the opposite foot. Repeat 5 times.
3.Throw a ball from one hand to the other, following it with the eyes. (10 times).
4.Walk in a hallway with eyes opened (1 minutes) and walk in a hallway with eyes closed. (1 minutes).
5.Stand with hand on a firm object, eyes closed and march in place counting to 30. Gradually lift off the hand in an attempt not to use it and march for another count to 30.
6 Place a cushion on the floor 5 ft away from the firm object. Place sheet of paper on wall with horizontal line on it at eye level, 10 – 15 ft away. Ask the subject to march in place on cushion looking at the horizontal line, using the firm object for support and count to 30.
Gaze stabilization exercises:
1.A business card or a target with words on it (foveal target) is taped in front of the patient so that the subject can read it. The subject first moves his head horizontally and then vertically for 1 minute keeping the words in focus.
2.Another test will be by holding a business card in front of the face so able to read it. The card and the head will be moved in opposite directions (initially horizontally for 1 minute then vertically) keeping the words in focus.
3.Other test will be Head fixed, object fixed & eye balls and Head, object & eye balls moving. This will be done for 1 minute each.
After each exercise there will a rest time for 1 minute
Conventional treatment:
Subject will be made to perform a series of head movements horizontally, gradually faster, as if expressing a “no”, keeping a fixed gaze on a point ahead. When the maximum frequency of the movement is reached, the subject stops and, 10 seconds later, restarts the procedure, that must be repeated ten times. Next, the series of movements must be done vertically, as if the subject expresses a “Yes” with the head.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1.Young adults Age between 18 to 26 years
2.Presence of signs and symptoms of motion sickness using Motion sickness Susceptibility Questionnaire Short form (MSSQ Short) as a screening tool.
3.The individuals with MSSQ score between 16 to 30 (moderate susceptibility) and 31 to 45 (High susceptibility) are included in the study.
4.Normal subjects without any pathology such as Migraine associated vertigo and Benign Paroxysmal Positional Vertigo (BPPV)
5.Subjects who are frequent travellers
|
|
| ExclusionCriteria |
| Details |
1.Individuals on medications for motion sickness
2.Individuals with any kind of central or peripheral vestibular pathologies
3.Subjects who are suffering from any kind of injury or fracture or any other pathology
4.Subjects having neurological and balance disorders
5.Subjects having psychosomatic and metabolic disorders and co morbidity
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Motion Sensitivity Testing or Motion sickness Quotient (MSQ)
2.Motion Sickness Assessment Questionnaire (MSAQ)
3.Vestibular Rehabilitation Benefits Questionnaire (VRBQ)
|
Baseline (Week 1, pre intervention) and Post-intervention (Week 6 after completion of intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
27/07/2025 |
| 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
|
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Brief Summary
|
Background Motion sensitivity, also referred to as motion sickness, is a common condition, with a prevalence of 28 percent in the general population. Motion sickness occurs due to a sensory conflict between the vestibular system and visual inputs. This sensory mismatch creates confusion in the brain, leading to the onset of symptoms. Despite Vestibular rehabilitation VR and Gaze stability exercises GSE potential, there is a lack of comprehensive research on their effectiveness in reducing motion sickness symptoms. Current VR and GSE protocols vary widely, highlighting the need for standardized, evidence-based approaches.
Purpose To determine the effect of vestibular rehabilitation and gaze stabilization exercises in individuals with motion sickness.
Methods Participants will be recruited on the basis of inclusion and exclusion criteria. Using the computer-generated random number, the participants will be randomly allocated into three groups. For six weeks, the group 1 will receive vestibular rehabilitation, gaze stability exercises and conventional treatment, the other group 2 will receive vestibular rehabilitation and conventional treatment while the other group 3 will receive only conventional treatment. Outcome measures Motion sickness Quotient MSQ, Motion Sickness Assessment Questionnaire MSAQ, Vestibular Rehabilitation Benefits Questionnaire VRBQ will be used to assess the subject pre intervention and post intervention.
Data Analysis Normality will be established with the help of Shapiro Wilk test. Demographics will be reported with the help of descriptive statistics. Parametric and non parametric test will be used to analyse within and between two groups. The level of significance will be kept at 0.05.
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