| CTRI Number |
CTRI/2024/04/066507 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of earphone use on vestibular reflexes and reaction time in young adults |
|
Scientific Title of Study
|
Impact of earphones on vestibulo-ocular reflex, vestibulo-spinal reflex,and reaction time among young adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Kapri |
| Designation |
PG Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No.1, Neurological OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala Haryana
Ambala
HARYANA
133207
India |
| Phone |
7060143303 |
| Fax |
|
| Email |
kapripreeti04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No.1, Neurological OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala Haryana
Ambala
HARYANA
133207
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Kapri |
| Designation |
PG Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No.1, Neurological OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala Haryana
Ambala
HARYANA
133207
India |
| Phone |
7060143303 |
| Fax |
|
| Email |
kapripreeti04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala, Haryana,India 133207 |
|
|
Primary Sponsor
|
| Name |
Preeti Kapri |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU) Mullana Ambala, Haryana 133207 |
| 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 |
| Prof Dr Nidhi Sharma |
Maharishi Markandeshwar Super Speciality Hospitall |
Room No. 1, Neurological OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala Haryana 133207, India
Ambala
HARYANA |
9760835605
sharma.nidhi.physio@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMIMSR Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vestibular Coordination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with age 18-25 years,
2.Healthy adults,
3.Able to walk independently,
4.Subject using earphones more than 1 hour 4 days in a week for more than 6 months,
5.Both Male and Female gender,
6.Able to follow verbal commands,
7.MMSE more than 24 |
|
| ExclusionCriteria |
| Details |
1.Any musculoskeletal, cardiovascular and neurological impairments refraining the individuals for participating in the study,
2.Any surgical history of lower limb,
3.Any visual deficit,
4.Any vestibular disorder or systematic illness of the ear/ears. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Doll’s Eye reflex Test
2.The Fukuda Step Test
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Ruler drop test |
Bsseline |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/05/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="24"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of the study is to determine the impact of earphones on vestibulo-ocular reflex, vestibulo-spinal reflex, and reaction time among young adults. College-going students age group = 18-25 years will be recruited for the study. Subjects will be asked to perform Oculocephalic reflex/ Doll’s Eye reflex Test to examine vestibulo-ocular reflex, the Fukuda Step Test to examine vestibulo-spinal reflex and reaction time will be examined through the Ruler drop test.Kolmogorov-Smirnov test will be used to determine normality. If the data is found to be normally distributed, the parametric test will be used. If the data is not found to be normally distributed, non-parametric tests, such as the Wilcoxon Signed rank test, will be used. |