| CTRI Number |
CTRI/2018/08/015409 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
17/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hearing loss and balance in older individuals |
|
Scientific Title of Study
|
Correlation of Auditory Vestibular Function and Postaral control in individuals with Presbycusis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahin Shah |
| Designation |
Student |
| Affiliation |
School Of Allied Health Sciences , MAHE |
| Address |
School of Allied Health Sciences , Department of Physiotherapy , MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9620556957 |
| Fax |
|
| Email |
mahinshah96@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishan M M |
| Designation |
Associate Professor |
| Affiliation |
School Of Allied Health Sciences , MAHE |
| Address |
School of Allied Health Sciences , Department of Speech and Hearing , MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9845141575 |
| Fax |
|
| Email |
kishan.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mahin Shah |
| Designation |
Student |
| Affiliation |
School Of Allied Health Sciences , MAHE |
| Address |
School of Allied Health Sciences , Department of Physiotherapy , MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9620556957 |
| Fax |
|
| Email |
mahinshah96@outlook.com |
|
|
Source of Monetary or Material Support
|
| Mahin Shah,Department of Physiotherapy
School Of Allied Health Sciences, MAHE , Manipal |
|
|
Primary Sponsor
|
| Name |
Mahin |
| Address |
Department of Physiotherapy , MAHE |
| 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 |
| Mahin Shah |
Kasturba Medical Hospital |
Department of Physiotherapy And Department of Speech And Hearing,School of Allied Health Sciences, Manipal Academy Of Higher Education
Udupi
KARNATAKA |
9620556957
mahinshah96@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Presbycusis (Age Related Hearing Loss), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with hearing loss
Presbycusis cases with degree of hearing loss from Mild-severe sensorineural. |
|
| ExclusionCriteria |
| Details |
No other organic cause of hearing loss
Co morbid medical conditions
Visual defects
Central balance dysfunction
Cognitive impairments
Lower limb defects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of auditory and vestibular function in individuals with presbycusis. |
One Time Evaluation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Checking age associated auditory-vestibular changes. |
One time Evaluation |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
27/08/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study aims to correlate auditory vestibular function with postural control in individuals with presbycusis. (Age-related hearing loss) There are very few studies done which objectively correlates Auditory and vestibular function and this study would provide the same. It will also correlate age-associated auditory vestibular function. Two departments would be conducting this study simultaneously namely, - Department of Physiotherapy and Department of Speech And Hearing.
|