| CTRI Number |
CTRI/2024/10/075110 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
No |
| 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 Gaze Stabilization protocol along with vestibular adaptation exercise for motion sickness |
|
Scientific Title of Study
|
Effectiveness of gaze stabilization therapy with vestibular adaptation exercises in motion sickness: 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 |
Sanika Yashwant Chendvankar |
| Designation |
Student |
| Affiliation |
Dr A.P.J Abdul Kalam College of Physiotherapy |
| Address |
405, Community physiotherapy department, 4th floor,
Dr A.P.J Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences, Loni, Tal: Rahata,
District: Ahmadnagar, Mahahrashtra
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8850364118 |
| Fax |
|
| Email |
sanikac2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepali HandePT |
| Designation |
HOD Community Physiotherapy Department |
| Affiliation |
Dr A.P.J Abdul Kalam College of Physiotherapy |
| Address |
405, Community PhysiotherapyDepartment, 4th floor,
A.P.J Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences, Loni, Tal: Rahata,
District: Ahmadnagar, Mahahrashtra
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8275034001 |
| Fax |
|
| Email |
deepali.hande@pmtpims.org |
|
Details of Contact Person Public Query
|
| Name |
Sanika Yashwant Chendvankar |
| Designation |
Student |
| Affiliation |
Dr A.P.J Abdul Kalam College of Physiotherapy |
| Address |
405, Community Physiotherapy Department, 4th floor,
Dr A.P.J Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences, Loni, Tal: Rahata,
District: Ahmadnagar, Mahahrashtra
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8850364118 |
| Fax |
|
| Email |
sanikac2001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanika Yashwant Chendvankar |
| Address |
Dr A.P.J. Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni, Tal: Rahata, District: Ahmanagar, Maharashtra, 413736. |
| 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 |
| Sanika Yashwant Chendvankar |
Community Physiotherapy Department |
405, Community physiotherapy Department, 4th floor,
Dr A.P.J Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences, Loni, Tal: Rahata,
District: Ahmadnagar, Mahahrashtra Ahmadnagar MAHARASHTRA |
8850364118
sanikac2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with Motion Sickness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Vestibular Adaptation Exercises
1. Head fixed, object fixed and eye balls moving. 2. Head fixed, object and eye balls moving. 3. Head moving, object fixed and eye balls moving.
4. Head, object and eye balls moving
Exercises Repetitions and time Duration
Rising while focused 5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions 10 minutes
Moving head while focused 5repetitions 30seconds
Total 20repetitions
2minutesbreakafterevery5repetitions 10 minutes
Focus on moving target 5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions 10 minutes
Move with moving target 5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions 10 minutes
|
| Intervention |
Experimental Group |
Experimental Group
Vestibular Adaptation Exercises
1. Head fixed, object fixed and eye balls moving.
2. Head fixed, object and eye balls moving.
3. Head moving, object fixed and eye balls moving.
4. Head, object and eye balls moving
Exercises Repetitions Duration
Rising while focused 5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions
10 minutes
Moving head while focused
5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions
10 minutes
Focus on moving target
5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions
10 minutes
Move with moving target
5 repetitions 30 seconds
Total 20 repetitions
2 minutes break after every 5 repetitions
10 minutes
Gaze Stability Exercises Home Program 1. Stand in a corner of the room 2. Hold or tape the exercise card at eye level against a plain background 3. Keep eyes focused on the letter E 4. Rotate head smoothly horizontally from side to side as tolerated for 1 minute, then rest for 1 minute 5. Perform this exercise for a total of 5 minutes daily during week 1 6. Week 2 through week 6, the investigator will recommend weekly exercise progression as tolerated 7. Please maintain a daily exercise log sheet and turn it in during weekly follow-up visit with the investigator
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 17 – 25 years.
2. Presence of signs and symptoms of motion sickness.
3. Normal subjects without any pathology |
|
| 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, fracture or any other pathology |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Motion sickness severity scale(MSSS)
2.Motion sickness assessment questionnaire(MSAQ) |
The data will be collected at baseline, week 3 and week 6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Motion Sensitivity Scale |
the data will be collected at baseline, week 3 and week 6 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
27/10/2024 |
| 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="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
|
|
Introduction
Motion
sensitivity, also referred to as motion sickness, is a common condition, with
a prevalence of 28% in the general population and more common in women
(27.3%) than in men (16.8%). Symptoms of motion sensitivity can be
experienced during land, air, sea, or space travel, resulting in impaired
function. According to the neural mismatch model proposed by Reason et al,
motion sensitivity can be defined as “a self-inflicted maladaptation
phenomenon that occurs at the onset and cessation of conditions of sensory
rearrangement when the prevailing inputs from the visual and vestibular
systems are at variance with stored patterns derived from previous
transactions with the spatial environment.â€1
Motion
is sensed by the brain through three different pathways of the nervous system
that send signals coming from the inner ear (sensing motion, acceleration,
and gravity), the eyes (vision), and the deeper tissues of the body surface
(proprioceptors). When the body is moved intentionally, for example, when we
walk, the input from all three pathways is coordinated by our brain. When
there is unintentional movement of the body, as occurs during motion when
driving in a car, the brain is not coordinating the input, and there is
thought to be incoordination or conflict among the inputs from the three
pathways. It is hypothesized that the conflict among the inputs is
responsible for motion sickness. Many of the drugs that are used to treat
motion sickness act by influencing or affecting the levels of these compounds
within the brain. Without the motion-sensing organs of the inner ear, motion
sickness does not occur, suggesting that the inner ear is critical for the
development of motion sickness. Visual input seems to be of lesser
importance, since blind people can develop motion sickness. Motion sickness
is more likely to occur with complex types of movement, especially movement
that is slow or involves two different directions (for example, vertical and
horizontal) at the same time.2
Three
main theories exist for motion sickness is as follows
1
The Sensory Conflict Theory
1.1
Visual-Vestibular Mismatch
1.2 Intra-vestibular (Canal-Otolith)
Mismatch Theory
2
The Poison Theory
|
3 The Postural Instability Theory
|
Physiology of Motion Sickness
|
Motion sickness is linked to a pronounced
activation of the glucocorticoid and sympatico-adrenergic stress response
systems. Number of pharmacological agents could potentially affect the occurrence
of motion sickness through their actions in the vestibular nuclei. The cerebral
cortex and limbic system, particularly the hippocampus, are major sites of
spatial orientation information processing. A number of neurotransmitters
influence the activity of vestibular nucleus neurons, including acetylcholine,
glutamate, glycine, GABA, histamine, norepinephrine, dopamine, serotonin,
substance P, somatostatin, adrenocorticotropic hormone [ACTH] and enkephalin.
The histaminergic neuron system in the brain has been supposed to play a
significant role in the pathophysiology of motion sickness. Neural mismatch
signals activates the histaminergic neuron system in the hypothalamus and
stimulates H1-receptors of the brainstem, therefore H1-receptors triggers the
development of the symptoms and signs of motion sickness, including emesis.
|
1 The Vestibular System
The
vestibular system is exaggerated by vertical and horizontal vibrations and
forces of acceleration. The vestibular system is maintaining the body balance;
it records change in movement caused by motion and coordinate the position of
the head through regulation of muscle tension which helps us keep our
posture. The vestibular system consists of semicircular canals and otolith
organs. Calcium carbonate crystals present on the otolith organs help us to
detect linear acceleration and the position of the head. The otoliths are
responsible for the opposite direction of visual signals when the head moves
in a roll motion, which is known to be ocular counter-rolling. The part that
detects angular acceleration is hair cells, called cilia, attached to the
inside walls of the semicircular canals. The vestibular nuclei receive MS
signals from the semicircular canals and otolith organs but also visual,
auditory, somatosensory, and proprioceptively related signals and a variety
of other afferents including from the cerebellum. The indication of angular
acceleration tells us that our head is moving1. Individuals with a total loss
of labyrinthine function are not susceptible to motion sickness.
2 The Visual System
|
|
The
visual system is crucial part of the phenomenon of MS as it coordinates us to
substantiate other organs such as vestibular, somatosensory and motor related
signals tell us to anticipate. Hence, an optical illusion of movement while
standing still, or an illusion of non-movement while moving will create a
conflict between signals to the brain from the optical vestibular system. A
conflict can also be created through an optical illusion of moving in an
opposite direction than the actual.
|
RESEARCH
QUESTION:
What will be the effect of Gaze Stabilization Therapy and Vestibular
adaptation exercises in motion sickness?
|
AIM:
To study the effects of Gaze
Stabilization Therapy and Vestibular adaptation exercises in motion sickness
OBJECTIVE
OF THE STUDY:
1.
To study the effects of vestibular adaptation
exercises in motion sickness
2.
To study the combined effects of gaze
stabilization therapy and vestibular adaptation exercises in motion sickness.
Hypothesis
Null
Hypothesis (H0): There will be no significant effect of
gaze stabilization therapy combined with vestibular adaptation exercises in
motion sickness.
Alternative Hypothesis (H1):There
will be significant effect of gaze stabilization therapy along with
vestibular adaptation exercises i n motion sickness.
|
METHODOLOGY:
·
STUDY SETTING: Dr. A.P.J. Abdul Kalam College of Physiotherapy.
·
DURATION OF STUDY: 6 Months
·
METHOD OF COLLECTION OF DATA: Data will be primary collected by principal investigator.
·
TYPE OF DATA:quantitative
·
STUDY DESIGN: experimental study
·
STUDY TYPE: Randomized Controlled Trial
·
SAMPLINGMETHOD: simple random sampling
·
SAMPLE SIZE: 50
·
STUDY POPULATION: Patients reporting to Medicine, ENT OPD,
PMT, Loni, Ahmednagar
413736.
|
Inclusion
criteria: 1.Age
between 17 – 25 years.
|
|
2.Presence
of signs and symptoms of motion sickness.
|
|
3.Normal
subjects without any pathology.
|
Exclusion
criteria:
•Individuals
on medications for motion sickness.
|
|
•Individuals
with any kind of central or peripheral vestibular pathologies.
|
|
•Subjects
who are suffering from any kind of injury, fracture or any other pathology Experimental
Group Vestibular
Adaptation Exercises 1. Head
fixed, object fixed and eye balls moving. 2. Head
fixed, object and eye balls moving. 3. Head moving,
object fixed and eye balls moving. 4. Head,
object and eye balls moving
|
Exercises
|
Repetitions
|
Duration
|
|
Rising while
focused
|
5 repetitions 30
seconds
Total 20
repetitions
2 minutes break after every 5 repetitions
|
10 minutes
|
|
Moving head while
focused
|
5 repetitions 30
seconds
Total 20
repetitions
2 minutes break after every 5 repetitions
|
10 minutes
|
|
Focus on moving
target
|
5 repetitions 30
seconds
Total 20
repetitions
2 minutes break after every 5 repetitions
|
10 minutes
|
|
Move with moving
target
|
5 repetitions 30
seconds
Total 20
repetitions
2 minutes break after every 5 repetitions
|
10 minutes
|
Gaze Stability Exercises Home Program 1. Stand
in a corner of the room 2. Hold
or tape the exercise card at eye level against a plain background 3. Keep
eyes focused on the letter E 4.
Rotate head smoothly horizontally from side to side as tolerated for 1 minute,
then rest for 1 minute 5.
Perform this exercise for a total of 5 minutes daily during week 1 6. Week
2 through week 6, the investigator will recommend weekly exercise progression
as tolerated 7.
Please maintain a daily exercise log sheet and turn it in during weekly
follow-up visit with the investigator Control
Group Vestibular
Adaptation Exercises 1.
Head fixed, object fixed and eye balls moving. 2.
Head fixed, object and eye balls moving. 3.
Head moving, object fixed and eye balls moving. 4.
Head, object and eye balls moving
|
Exercises
|
Repetitions
and time
|
Duration
|
|
Rising
while focused
|
5 repetitions 30
seconds
Total 20
repetitions
2 minutes break after every 5 repetitions
|
10
minutes
|
|
Moving
head while focused
|
5repetitions 30seconds
Total 20repetitions
2minutesbreakafterevery5repetitions
|
10
minutes
|
|
Focus
on moving target
|
5
repetitions 30 seconds
Total
20 repetitions
2
minutes break after every 5
repetitions
|
10
minutes
|
|
Move
with moving target
|
5
repetitions 30 seconds
Total
20 repetitions
2
minutes break after every 5
repetitions
|
10
minutes
|
OUTCOME
MEASURES:
1. Motion sickness severity
scale(MSSS).
2. Motion
sickness assessment questionnaire(MSAQ).
|
|
|
|
|
|
|