| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly Population |
|
|
Intervention / Comparator Agent
|
|
|
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.
|
|
|