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CTRI Number  CTRI/2024/04/065279 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Customized progressive cognitive activity training and its effect on cognitive parameters in acute stage of stroke 
Scientific Title of Study   Customized progressive activity training and its effect on cognitive parameters in acute stage of stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prerana D Nargund 
Designation  Post Graduate Student 
Affiliation  SDM College Of Physiotherapy 
Address  SDM College Of Physiotherapy, Sattur, Dharwad.
SDM College Of Physiotherapy, Sattur, Dharwad.
Dharwad
KARNATAKA
580009
India 
Phone  8217052387  
Fax    
Email  prerananargund3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prerana D Nargund 
Designation  Post Graduate Student 
Affiliation  SDM College Of Physiotherapy 
Address  SDM College Of Physiotherapy, Sattur, Dharwad.
SDM College Of Physiotherapy, Sattur, Dharwad.

KARNATAKA
580009
India 
Phone  8217052387  
Fax    
Email  prerananargund3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prerana D Nargund 
Designation  Post Graduate Student 
Affiliation  SDM College Of Physiotherapy 
Address  SDM College Of Physiotherapy, Sattur, Dharwad.
SDM College Of Physiotherapy, Sattur, Dharwad.

KARNATAKA
580009
India 
Phone  8217052387  
Fax    
Email  prerananargund3@gmail.com  
 
Source of Monetary or Material Support  
SDM COLLEGE OF PHYSIOTHERAPY 
 
Primary Sponsor  
Name  PRERANA D NARGUND 
Address  SDM COLLEGE OF PHYSIOTHERAPY, MANJUSHREE NAGAR, 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 
Dr Sudhir Bhatbolan  SDM COLLEGE OF PHYSIOTHERAPY  OPD NO.05 Neurophysiotherapy Department, Shri Dharmasthala Manjunatheshwara College Of Medical Science And Hospital, Manjushree Nagar, Sattur, Dharwad.
Dharwad
KARNATAKA 		 9886475757

bhatbolan12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group- routine rehabilitation training   Control group- routine rehabilitation training: Passive joint movement, active training of the affected limb/ limbs, turning exercises from the healthy side to the affected side, sitting balance training, and standing balance training. ADL training content include moving body, putting on and taking off clothes, grooming, eating, toileting in a progressive customized manner as per the requirement of individual patients.  
Intervention  Experimental group- routine rehabilitation training along with customized cognitive training  Experimental group- routine rehabilitation training along with customized cognitive training: The patients in this group will receive routine rehabilitation training along with the cognitive training. Cognitive training will include - activities for the orientation, attention, calculation, memory, problem solving ability, language and executive functioning. The training activates designed as progressive interactive play modules which are repetitive and with increasing level of difficulty on a weekly basis. Training is given for 30-40 mins every day. The training is updated weekly in accordance with the level of difficulty. Following is the week wise cognitive training. Week-1 1 Days of the week 2 Recognition of right and left 3 Searching for the target among the distractors 4 Calculation level 1 5 Remembering the list of objects level 1 6 Maze level 1 Week 2 1 Months of the year 2 Identification of the objects level 1 3 Find out 4 Calculation level 2 5 Remembering the list of objects level 2 6 Maze level 2 Week 3 1 Months and seasons 2 Identification of the objects level 2 3 Finding the difference between images 4 Calculation level 3 5 Remembering the list of objects level 3 6 Maze level 4 Week 4 1 Anagrams of the days of week 2 Orienting the skills of the following 3 Searching for the elements by categories 4 Calculation level 4 5 Memory games with cards 6 Maze level 4 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. First time stroke survivors in the age group 18 to 70 years
2. Patients who are in acute phase of stroke but are medically stable
3. All the genders will be included
4. Patients with intact visual and auditory function
5. The conscious state 13-15 in Glasgow Coma Scale (GCS)
6. Patients of Mini Mental State Examination (MMSE) score of 24 to 18 i.e., mild to
moderate cognitive impairment
7. Participants who are willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Patients with any previously known musculoskeletal or neurological degenerative
conditions such as Alzheimer’s or Parkinson’s.
2. Patient with sensory or global aphasia.
3. Patients with history of psychiatric illness or previous cognitive impairment.
4. Uncooperative or Unwilling participants. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
TRAIL MAKING TEST
MINI MENTAL STATE EXAMINATION
DIGIT SYMBOL SUBSTITUTION TEST 		 BASELINE AND 4TH WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 1 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/04/2024 
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   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 a major global health issue and a leading cause of mortality and morbidity in developed countries. It is classically defined as a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) caused by a vascular cause, including cerebral infarction, intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH).1 Stroke as defined by WHO states “clinical symptoms of focal (or global) alteration of cerebral function that occur suddenly and persist for more than 24 hours or may result in death with no other obvious cause other than vascular origin”.1 A stroke is a "brain attack" caused by either decreased blood and oxygen flow to the brain or bleeding.2 The significant increase in the global burden of stroke was most likely caused not only by population growth and ageing, but also by a significant increase in exposure to several important risk factors such as obesity, ambient particulate matter pollution, high fasting plasma glucose, high systolic blood pressure, alcohol consumption, low physical activity, kidney dysfunction, and high temperature.3 The Global Burden of Disease research estimates the number of stroke incidents in India in 2016 to be 1,175,778. According to a recent systematic review of cross-sectional research, the incidence of stroke in India is estimated to be between 105 and 152/100,000 individuals per year.4 Stroke rates increased from 1.8/1000 people per year in the 55-64 age group to 17 in those 85 and older in the Oxford vascular study.5 The brain is a highly organized structure made up of intricate networks that are associated with functions in the areas of sensory perception, motor control, and cognitive function.6 When an ischemia or hemorrhagic stroke affects one or more of these arteries, the portion of the brain that is not receiving enough blood begins to degenerate, leading to deficits in physical and cognitive function. The degree of neurological recovery, the place of the lesion, the patient’s premorbid condition, and the environmental support system are all factors in the multifactorial determination of disability.1,2 Apart from physical disability, stroke causes severe cognitive impairment in onethird of patients. 5 Following a stroke, there is an increase in chance of continuing cognitive impairment of at least 5- 8 times.6 The processes by which humans gather, analyze, retain, and use environmental information are referred to as cognitive processes.7 A person with cognitive impairment has difficulty remembering, picking up new information, focusing, or making judgements that have an impact on their daily lives.8 Memory, attention, visuospatial functioning, executive function, and language are all domains of cognition.9 Cognitive impairment is characterized by a spectrum of mental deterioration to severe decline in cognitive function.10 The etiology of poststroke cognitive impairment (PSCI) is influenced by lesions in critical regions like the cerebral cortex, white matter, and hippocampus, despite the fact that the precise mechanism underlying PSCI is not yet fully understood.11 Lesions in the dominant hemisphere impair the prefrontal-subcortical network that mediates executive dysfunction, resulting in issues with language function, attention, memory, concentration, and executive skills. Depending on the nations, the races, and the diagnostic standards, the prevalence of PSCI ranges from 20% to 80%.11,12 Even after recovering from a severe disability, PSCI can still have an impact on a patient’s capacity for independent living. Consequently, it’s imperative to discover effective therapies for stroke survivors’ cognitive deficiencies.12 The most prevalent non-physical impairment in stroke survivors is cognitive dysfunction yet a neglected complication.12,13 Up to 57% of ischemic stroke survivors experience cognitive impairment at even 6 months after the stroke. Cognitive impairment is linked to a lower quality of life, higher rates of mortality and institutionalization, a greater load on family carers, and higher healthcare expenses.13 A system-based intervention of therapeutic cognitive activities based on the evaluation and comprehension of the patient’s brain behavior impairments is known as cognitive rehabilitation and it aims at slow, progressive, early and multi-dimensional cognitive function training.14 Early cognitive evaluation is essential for planning tailored rehabilitation programs, according to stroke recommendation. 15 Instruments like Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) are frequently employed as an effective way to quickly evaluate cognition following a Stroke. 15 Other outcome measures used are Digit Symbol Substitution Test (DSST) and Trail Making Test (TMT). The DSST is a valid measure of cognitive dysfunction and can be used to detect clinically relevant treatment effects in patients. The performance on DSST correlates with real-world functional outcomes and recovery from functional disability. 16 One of the most widely used neuropsychological tests, the Trail Making Test (TMT), is a component of most test batteries. It assesses visual search, scanning, processing speed, mental flexibility, and executive skills. 17 The focus of rehabilitation is frequently on motor deficiencies, despite recent international consensus-based core recommendations identifying cognitive function post-stroke as an area of unmet need. 12 Nonpharmacological therapies have received a lot of attention recently. For stroke patients, cognitive rehabilitation is seen as a therapeutic approach to retain and enhance cognitive abilities.12 As a result, poststroke cognitive impairment is a significant factor influencing patient rehabilitation outcomes and the impact of physical dysfunction. There are the evidences to support the fact that neural plasticity is most significant during the first week to the first month following a stroke (acute and early subacute phases) and ought to be the goal of recovery trials8 . Therefore early initiation of cognitive rehabilitation training may enhance not only the cognitive dysfunction of stroke patients, but also the recovery of patients’ activities of daily living (ADL).14 Furthermore, while there is evidence that motor rehabilitation after stroke should begin as soon as possible, i.e. when the treatment’s impact is potentially greater, only a few studies have addressed early cognitive rehabilitation after stroke.18,19 Prokopenko et al. presented preliminary evidence for the therapeutic benefits of early (within two weeks of stroke) cognitive training, based on the use of computer programs for restoring impairment in attention and visuospatial abilities.20 But there is dearth of studies and evidences which support the early approach to managing cognitive aspects and therefore needs to be investigated. There are many technological advanced cognitive training programs that have been found useful21,22, but they can be costly and have a low rate of compliance once the patient is discharged from the hospital. There is a paucity of evaluation and therapy in the acute period of stroke owing to this barrier. A simple, structured activity-based therapy that is easy to administer even in home setting, while being cost effective, enticing for the patient, appropriate and progressively challenging the cognitive system needs to be formulated and its outcome evaluated. The involvement of caretakers in ensuring the continuity of therapy delivery and maintain the compliance is a key factor which is highlighted in this study. Thus, there is a strong need to understand the effect of early initiated simple, structured and customized activity-based therapy and its effect on cognitive parameters among stroke survivors. 
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