| CTRI Number |
CTRI/2024/09/073530 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of gaze stability and habituation exercises on Motion sickness in young adults |
|
Scientific Title of Study
|
Combined Effect of Gaze Stability Exercises and Habituation Exercises on Kinetosis in Young
Adults- Randomized Controlled Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prathwiya Vakshitha |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Yenepoya Physiotherapy College,University road,Deralakatte,Mangaluru ,575018
Yenepoya Medical Hospital ,Department of Physiotherapy ,Deralakatte,Mangaluru ,575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8310976455 |
| Fax |
|
| Email |
vakshithavakshu45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prathwiya Vakshitha |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Yenepoya Physiotherapy College,University road,Deralakatte,Mangaluru ,575018
Yenepoya Medical Hospital,Department of Physiotherapy,Deralakatte,Mangaluru ,575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8310976455 |
| Fax |
|
| Email |
vakshithavakshu45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prathwiya Vakshitha |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Yenepoya Physiotherapy College,University road,Deralakatte,Mangaluru ,575018
Yenepoya Medical Hospital,Department of Physiotherapy ,Deralakatte,Mangaluru ,575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8310976455 |
| Fax |
|
| Email |
vakshithavakshu45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Population with motion sickness, conducted at Yenepoya Medical Hospital, Derlakatte,Mangalore |
|
|
Primary Sponsor
|
| Name |
Prathwiya Vakshitha |
| Address |
Yenepoya Physiotherapy College,University road,Deralakatte,Mangaluru ,575018 |
| Type of Sponsor |
Other [Self funding type] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prathwiya Vakshitha |
Yenepoya Physiotherapy College,University road,Deralakatte,Mangaluru ,575018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smitha D PT |
Yenepoya Medical Hospital |
Yenepoya Department of Physiotherapy and occupational therapy ,7th floor, main block (emergency department block)
Dakshina Kannada
KARNATAKA |
8310976455
smithad@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Motion sickness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing combined gaze stability and habituation exercise with deep breathing exercise |
Experimental group will be given gaze stability and habituation exercise and the control group will be given deep breathing exercise, four times in a week for 20minutes 10minutes for experimental group 10minutes for control group , total duration for both will be 320minites |
| Intervention |
Gaze stability and habituation exercises |
Participants are given gaze stability and habituation exercise together and check its effect on motion sickness four times in a week for 10minutes each session , total duration for this intervention will be 200minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Individual with motion sickness included by answering the Motion sickness Susceptibility Questionnaire.
b) Young adults of age 18years-35 years. |
|
| ExclusionCriteria |
| Details |
a) Individual with moderate to severe vertigo
b) Individual with any other neurological complications
c) Person with dizziness and other vestibular
complications
d) Person with oculomotor disease
e) Person with migraine
f) Individual with cardiovascular disease
g) Any musculoskeletal disorder
h) Seizure disorder
i) Individual with gastrointestinal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Motion sickness susceptibility questionnaire to include the participants in the study according to motion sickness inclusion criteria
2.Motion sickness assessment questionnaire to know severaity of the problem in a person pre and post treatment |
1.Motion sickness susceptibility questionnaire which takes 10min approximately for each person
2.Motion sickness assessment questionnaire at baseline and after 4weeks( post treatment)which takes approximately 10min for each person |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/10/2024 |
| 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="0"
Months="1"
Days="0" |
|
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
|
Participants of age group between 18years to 35years are involved in this research with there concent. The inclusion criteria for the study is done according to the answers given to the questionnaire. The study includes two group :experimental group and control group. Participants are randomly alloted to both the groups. Experiment group will include Gaze Stability exercise and Habituation exercises four times a week for four weeks ,The control group includes Deep breathing exercise four times a week for four weeks. The baseline , after four weeks and follow up assessment after one month will be taken and compare it within and between the group. Objective here is to find out that weather the Gaze Stability Exercises and Habituation exercise is effective or not on motion sickness among young Adults. |