| 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
|
|
|
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
|
|
|
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
3 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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