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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.”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). 


 
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