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CTRI Number  CTRI/2019/09/021124 [Registered on: 09/09/2019] Trial Registered Prospectively
Last Modified On: 06/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The survey to find out the number of individuals having difficulty in remembering or learning new things and its effect on mobility and balance in elderly population in Hubli Dharwad 
Scientific Title of Study   Prevalence of Mild Cognitive Impairment and its impact on functional mobility parameters among elderly in Hubli Dharwad 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudhir Bhatbolan 
Designation  Assistant Professor 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9886475757  
Fax  08362462253  
Email  sudhirbhatbolan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chougule Snehal Sanjay 
Designation  Post Graduation Student 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9136838656  
Fax  08362462253  
Email  snehalchougule71@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chougule Snehal Sanjay 
Designation  Post Graduation Student 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9136838656  
Fax  08362462253  
Email  snehalchougule71@gmail.com  
 
Source of Monetary or Material Support  
Neurophysiotherapy Opd Ground floor Multi Speciality building Sattur Dharwad 
 
Primary Sponsor  
Name  Chougule Snehal Sanjay 
Address  Neurophysiotherapy Opd Ground floor Multi Speciality building Sattur Dharwad 
Type of Sponsor  Private medical college 
 
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 
Chougule Snehal Sanjay  Senior Citizens Associations and Clubs  Senior Citizens Associations and Clubs in Hubli Dharwad
Dharwad
KARNATAKA 
9136838656
08362462253
snehalchougule71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM Instituttional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly Population 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  61.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Individuals over 60 years of age
Urban residents of Hubli Dharwad
Both the genders will be included
Apparently healthy individuals without any known or diagnosed neurological or neuro degenerative conditions like Stroke Parkinson Alzheimer etc
Individuals who are able to read write and understand English Hindi or Kannada
 
 
ExclusionCriteria 
Details  Individuals who are hospitalized
Individuals with any known/established neurological or neuro degenerative conditions
Individuals who have comorbidities that interfere with independent ambulation
Individuals not willing to participate in the study
Individuals who are unable to understand the instructions of MoCA and mini-BEST
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MoCA
Mini BESTest 
10 minutes
10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   Phase 3 
Date of First Enrollment (India)   22/09/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Mild Cognitive Impairment is often seen alongside near normal ADLs there are mentions that suggest the involvement of functional mobility features which are important pre-determinants of ADLs that co-exist. Due to the known concurrence of Mild Cognitive Impairment and decline in attributes of physical functional parameters they become early tell-tale components that should be mandated to be looked into in order to pick up any functional decline. This may allow prompt intervention and adopt proactive prevention strategies and call on appropriate medical initiatives timely.  A study of this nature is a step towards understanding the prevalence of Mild Cognitive Impairment in the Indian scenario, and the interplay of subtly receding cognitive and mobility parameters which are expected age wise but not adequately explored and their relationship not well explained. In light of salience of these two domains functioning to individuals ability to live independently and to maintain quality of life there is a need to elucidate the casual relationship between Mild Cognitive Impairment and functional mobility. Hence, the need for this study.

 
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