| CTRI Number |
CTRI/2025/08/092379 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Neck Position Sense And Eye Stability Reflex In People With And Without Near Sightedness |
|
Scientific Title of Study
|
Comparison of neck proprioception and vestibulo-ocular reflex among emmetropes and myopes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghana T R |
| Designation |
Post Graduate |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9611168338 |
| Fax |
|
| Email |
megha17tr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amratha G Shetty |
| Designation |
Assoc Prof |
| Affiliation |
|
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9945208205 |
| Fax |
|
| Email |
amrathagshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meghana T R |
| Designation |
Post Graduate |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9611168338 |
| Fax |
|
| Email |
megha17tr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| DR Meghana T R |
ALVAS COLLEGE OF PHYSIOTHERAPY |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9611168338
megha17tr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALVAS COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H531||Subjective visual disturbances, (2) ICD-10 Condition: H531||Subjective visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Myopic individuals
Age between 18-25 years
Both male and female are included
Individuals not diagnosed with any vestibular neurological conditions cervical spine injuries
Individuals with no use of vestibular suppresants muscle relaxants or neuro active drugs
|
|
| ExclusionCriteria |
| Details |
Individuals with history of cervical spine injuries
Individuals being on sedatives and CNS medications
History of ear disorders vertigo dizziness imbalance
head and neck trauma and anomalies
History of frequent headaches or migraines
Unwillingness to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cervical Joint Position Error Test
Dynamic Visual Acutiy Test
Snellens Chart Test |
T0-Cervical Joint Position Error Test
T1-Dynamic Visual Acutiy Test
T2-Snellens Chart Test
T0-10min,T1-10mim,T2-10MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
16/08/2025 |
| 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="0"
Months="9"
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
|
Abstract Background Myopia is a growing global public health concern, particularly among younger populations. Recent evidence suggests that beyond impairing visual acuity, myopia may influence neuromuscular systems such as cervical proprioception and the vestibulo-ocular reflex, both of which are critical for postural stability and gaze control. However, limited studies have directly compared this parameters between individuals with normal vision (emmetropes) and this with myopia. Objective To compare neck proprioception and vestibulo-ocular reflex function between emmetropic individuals and individuals with myopia, and assess the correlation between this two systems in both groups. Methods This is a comparative cross-sectional study involving 72 participants (36 emmtropes and 36 myopes), aged 18-25 years, recruited from colleges under Alvas education foundation. Neck proprioception was assessd using joint position error (JPE) testing, and VOR function was evaluated using the Dynamic visual acuity (DVA) test. Participants with vestibular neurological cervical spine disorders or on CNS active medications were excluded. Statistical analysis included the Shapiro-wilk test for normality, independent t test for group comparison, and Pearson correlation to assess relationships between proprioception and VOR. Expected outcomes We anticipate finding significant difference in neck proprioception and VOR function between myopic and emmetropic individuals with a possible correlation between the two variables.Ths findings could contribute to a deeper understanding of sensorimotor integration in myopia and inform holistic approaches in myopia rehabilitation Keywords Myopia, Emmtropia, Neck proprioception, Vestibulo-ocular reflex, Joint position error, Dynamic visual acuity. |