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CTRI Number  CTRI/2024/08/072212 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   The Effect of Cognitive Load on Cognitive Motor Interference in Post Stroke Individuals  
Scientific Title of Study   Assessment of Cognitive Motor Interference in Post Stroke Individuals Under Different Cognitive Load 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  Sakshi Kajale 
Designation  PG student 
Affiliation  MAEERS physiotherapy college 
Address  MAEERS physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin number A-230 talegaon dabhade

Pune
MAHARASHTRA
410507
India 
Phone  8421154603  
Fax    
Email  sakshikajale5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumitra Sakhwalkar  
Designation  Proffessor  
Affiliation  MAEERS physiotherapy college 
Address  MAEERS physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin number A230 talegaon dabhade

Pune
MAHARASHTRA
410507
India 
Phone  9049998861  
Fax    
Email  sumitra26@mitmimer.com  
 
Details of Contact Person
Public Query
 
Name  Dr sumitra sakhwalkar  
Designation  proffessor  
Affiliation  MAEERS physiotherapy college 
Address  MAEERS physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin number A-230 talegaon dabhade

Pune
MAHARASHTRA
410507
India 
Phone  9049998861  
Fax    
Email  sumitra26@mitmimer.com  
 
Source of Monetary or Material Support  
MAEERS physiotherapy college talegaon dabhade - 410507 Maharashtra india 
 
Primary Sponsor  
Name  MAEERS college of physiotherapy 
Address  MAEERS physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin number A230 talegaon dabhade 410507 Maharshtra India 
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 
Dr sumitra sakhwalkar  MAEERS physiotherapy college  MAEERS physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin number A230 talegaon dabhade
Pune
MAHARASHTRA 
90499988661

sumitra26@mitmimer.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERS College of physiotherapy ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cognitive motor interfernce  after recruitment of participant they will be instructed to perform timed up and go test with cognitive task. i.e. to count backwards from the given number after that cognitive motor interfernce will be calculated 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Adults with chronic stroke tat is stroke duration more than 6 months
2 Post stroke individuals having ability to walk independently with or without any assistive device for 10m distance
3 Post stroke individuals with MMSE score more than24 
 
ExclusionCriteria 
Details  1 Post stroke individuals with any other systemic illness,e.g. myocardial infarction, asthma
2 Post stroke individuals with any surgery within past 6 months
3 Post Stroke individuals with diagnosed psychiatric disorder e.g. Alzheimer’s
4 Post stroke individuals with diagnosed vestibular dysfunction
5 Post Stroke individuals with uncontrolled hypertension 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time up & go test to assess gait speed  baseline assessment at 0 week 
 
Secondary Outcome  
Outcome  TimePoints 
cognitive motor interference to asess ability to do dual task   nil 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   10/09/2024 
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="10"
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  
Stroke is fairly frequent in older persons and is defined as a neurological impairment of cerebrovascular origin.There is mounting evidence that both the risk and degree of cognitive impairment are increased by stroke. Following a stroke, people with cognitive impairment frequently experience problems with their quality of life and need constant support, which has a significant impact on caregivers and society at large 1
Cognitive impairment following an ischemic stroke is a prevalent and incapacitating outcome 2 . Stroke is one of two leading causes of disability-adjusted life-years worldwide, and post-stroke cognitive impairment (PSCI) has been shown to be common among stroke survivors. Measured within 1.5 years post-stroke, recent reviews and meta-analyses found a pooled prevalence of PSCI of 53.4% and moderate and major PSCI of 36.4–38 and 16%, respectively Given the high correlation between cognition and gait, the cognitive-motor interference (CMI) approach, which employs dual task (DT) walking, may offer a novel methodological technique for assessing brain function in motor cognitive impairment (MCI).  When doing a cognitive and a motor activity simultaneously (dual-task performance), as opposed to performing each task independently (single-task performance), performance in one or both tasks deteriorates. This phenomenon is known as cognitive-motor interference, or CMI.for example, we frequently walk in the community while conversing with a companion or walk through the grocery store while recalling items for purchase 8  Assessments using dual-task (DT) walking allow for the investigation of cognitive function and functional ambulation at the same time, and crucially, they also shed light on the interactions between these two processes. The walking performance metrics measured, gait speed is one of the most commonly examined motor performance variables in DT investigations of post-stroke. Following a stroke, motor and cognitive impairments are commonly seen, but they are typically treated as distinct conditions with minimal evidence connecting them. Subsequent research has demonstrated a connection between executive function (EF) and attention deficits and the impact of dual tasking on gait velocity. Our goal is that this innovative and comprehensive analysis of existing literature will draw attention to the limitations of the experimental setups used today and provide guidance for better dual-task study design and reporting in stroke.However, despite widespread clinical use and functional significance of the Timed Up-and-Go (TUG), the effect of CMI on TUG testing has been less commonly studied in individuals post-stroke.
procedure-
Institutional ethical aprroval wil be obtain after that purposive sampling will be done according to inclusion and exclusion criteria and information sheet will be distributed among the included individuals which will describe the need purpose and nature of the study. after that demographic data will be collected along with the consent form. then instructions such as counting backwards from given number will be given to the individual for assessment of simple cognitive task with the motor task(timed up and go ) and for increasing the complexity of the task individual then instructed to as you have to do serial subtraction three from given number with motor task(timed up and go). after the data collection all the collected data will be analysed using appropriate statistical test. 

 
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