Customized progressive cognitive activity training and its effect on cognitive parameters in acute stage of stroke

Phase 1

Not yet recruiting

Conditions: Hemiplegia, unspecified,

Registration Number: CTRI/2024/04/065279

Lead Sponsor: PRERANA D NARGUND

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 â€œclinical 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 originâ€.1A 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.3The 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.4Stroke 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.5The 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.6The 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.10The 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.12The 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.13A 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.14Early 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. 17The 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.12As 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).14Furthermore, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

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.

Exclusion Criteria

Patients with any previously known musculoskeletal or neurological degenerative conditions such as Alzheimerâ€™s or Parkinsonâ€™s.
Patient with sensory or global aphasia.
Patients with history of psychiatric illness or previous cognitive impairment.
Uncooperative or Unwilling participants.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TRAIL MAKING TEST	BASELINE AND 4TH WEEK
MINI MENTAL STATE EXAMINATION	BASELINE AND 4TH WEEK
DIGIT SYMBOL SUBSTITUTION TEST	BASELINE AND 4TH WEEK

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): SDM COLLEGE OF PHYSIOTHERAPY
🇮🇳
Dharwad, KARNATAKA, India
SDM COLLEGE OF PHYSIOTHERAPY
🇮🇳Dharwad, KARNATAKA, India
Dr Sudhir Bhatbolan
Principal investigator
9886475757
bhatbolan12@gmail.com