FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077778 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Investigation of postural control in older adults during Vestibular ocular reflex visual conflict task. 
Scientific Title of Study   Postural Control In Older Adults With Vestibular Ocular Reflex Visual Conflict Task In Different Sensory Conditions : A Cross Sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Majumi M Noohu 
Designation  Professor 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Room No 105, First Floor Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi

New Delhi
DELHI
110025
India 
Phone  09868023378  
Fax    
Email  mnoohu@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Majumi M Noohu 
Designation  Professor 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Room No 105, First Floor Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi

New Delhi
DELHI
110025
India 
Phone  09868023378  
Fax    
Email  mnoohu@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  Saadia Firdous 
Designation  Student 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Room No 208, Second Floor Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi

New Delhi
DELHI
110025
India 
Phone  7015932699  
Fax    
Email  firdoussaadia15@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Okhla, New Delhi- 110025 
 
Primary Sponsor  
Name  Jamia Millia Islamia  
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi- 110025 
Type of Sponsor  Government funding agency 
 
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 
Dr Majumi M Noohu  Centre for Physiotherapy and Rehabilitation Sciences  Room No 201 Human Performance Lab Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi- 110025
New Delhi
DELHI 		 09868023378

mnoohu@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Jamia Millia Islamia New Delhi 110025  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy People within the age groups of 20-40 and 60-80 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Subjects without any history of fall, with good general health and cognition, able to stand and walk  
 
ExclusionCriteria 
Details  Vestibular Impairment
Any neurological condition
Any musculoskeletal injury
Any metabolic disease 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Muscle Activation Patterns
Centre of Pressure Sway
Postural Analysis


 		 One Time (On day 1)


 
 
Secondary Outcome  
Outcome  TimePoints 
Co- contraction Index
Reaction Time 		 One Time (On day 1) 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   16/12/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   As ageing is associated with several changes in each systems of the body which also includes alterations in the sensory systems that is the somatosensory, visual and vestibular systems. One of the major component of the vestibular system is the vestibular ocular reflex (VOR) which has been also shown to decline with ageing but to the best of my knowledge, its effectiveness and impact on elderly in postural control is still limited. How an individual will integrate or compensate when one or more of these are challenged including VOR is yet not evident. Clinically, the importance of sensory strategy incorporating VOR  is not established yet.
All the subjects will be informed about the nature, purpose, and possible risks involved in the study and an informed written consent will be taken from them prior to participation. All the subjects will be selected based on the inclusion criteria. Subjects will be familiarized for the activity. After recruitment , the subjects have to perform six sensory conditions: standing with Eyes Open and Eyes Closed on a Firm and Foam surface respectively and two additional conditions of VOR which involves the subject to keep the eyes fixed on a target in front  and simultaneously rotating the head horiziontally on firm and foam surface respectively. During the performance the subject will be tested for Muscle activation patterns, Centre of pressure sway. Lastly, postural analysis will be done to know the angular deviations. Overall, the study will give an idea of the role of VOR on postural control in elderly.
 
Close