| CTRI Number |
CTRI/2025/08/093656 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) Other (Specify) [COGNITIVE EXERCISES] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Restoring Function and Awareness: A Study of Post-Stroke Rehabilitation |
|
Scientific Title of Study
|
Impact Of Post Stroke Rehabilitation On Self Awareness, Functional Activities And Muscle Strength Among Stroke Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopa Biswas |
| Designation |
PhD Research Scholar |
| Affiliation |
WEST BENGAL NURSING COUNCIL |
| Address |
NH 9 DELHI ROAD MORADABAD UTTAR PRADESH Pin 244001 DO Moradabad UTTAR PRADESH 244001 India |
| Phone |
9903932138 |
| Fax |
|
| Email |
biswasgopa218@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr M Jasline |
| Designation |
Professor |
| Affiliation |
Teethanker Mahaveer University, College of Nursing |
| Address |
Teethanker Mahaveer University College of Nursing NH 9 DELHI ROAD MORADABAD UTTAR PRADESH 244001 NH-9 DELHI ROAD MORADABAD UTTAR PRADESH Pin 244001 Moradabad UTTAR PRADESH 244001 India |
| Phone |
8279816167 |
| Fax |
|
| Email |
drjaslinejohn.msn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Soumik Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
WEST BENGAL UNIVERSITY OF HEALTH SCIENCES |
| Address |
IQ City Medical College Hospital
Bizra Road Paschim Bardhaman IQ City Medical College Hospital
Bizra Road Paschim Bardhaman Barddhaman WEST BENGAL 713206 India |
| Phone |
7980121970 |
| Fax |
|
| Email |
soumiksarkar08@gmail.com |
|
|
Source of Monetary or Material Support
|
| TEETHANKER MAHAVEER UNIVERSITY
NH 2 DELHI ROAD MORADABAD 244001 UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
GOPA BISWAS |
| Address |
R II 9 BIDHANNAGAR HOUSING COLONY PASCHIM BARDHAMAN DURGAPUR 713206 WEST BENGAL |
| Type of Sponsor |
Other [SELF] |
|
|
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 SOUMIK SARKAR |
OPD IPD OF MEDICAL NEUROLOGY DEPARTMENT AND PHYSIOTHERAPY OF IQ CITY MEDICAL COLLEGE HOSPITAL |
BIZRA ROAD PASCHIM BARDHAMAN PIN 713206 WEST BENGAL Barddhaman WEST BENGAL |
7980121970
soumiksarkar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE TEETHANKER MAHAVEER DENTAL COLLEGE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARATOR |
Control group will get treatment according to hospital protocol. There will be no connection or relation with the intervention of experimental group. |
| Intervention |
INTERVENTION |
Intervention will be given to experimentl group. Implementation of post stroke rehabilitation module includes cognitive rehabilitation training and task oriented exercises of upper extremity among stroke patients. Exercises will be provided eight weeks, one hour session, three times per week, with a minimum eight to ten exercises per session. Cognitive exercises include auditory comprehension, daily activities, playing with coins, playing with cards, playing with nuts and bolts, writing skill, memory recall, categorization exercises, time exercises, deductive reasoning, drawing figures, fine motor control, auditory attention, right left orientation, mathematical reasoning, recall of stories and events. Task oriented exercises include three types of exercises. Arm stretching exercises include lifting the arm, extending the elbow, turning the fore arm, extending the fingers and extending the thumb. Secondly arm muscular strengthening exercises include lifting an object, extending the elbow, extending the wrist and opening the hand. Lastly arm functional exercises include drawing a line, moving a ball, using a spoon, dressing the hair, opening a bottle, holding a cap, turning on a cap, writing, turning pages, throwing a ball and throwing a ball to someone.
OGNITIVE EXERCISES FOR TEN MINUIES
FUNCTIONAL EXERCISES FOR TWENTY MINITES
MUSCLE STRENGTH EXERCISES THIRTY MINUTES
ALL EXERCISES MAXIMUM THREE REPETITION GRADUALLY
TWO AND HALF MINUTES RELAXATION AFTER THIRTY MINUTES OF PRACTICES
SIXTY MINUTES THERAPY PER DAY
EIGHT TO TEN EXERCISES PER DAY |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with stroke according to CT scan or
MRI examination reports of brain and admitted
within 2 weeks of stroke at IQ City Medical
College and Hospital
2. Stroke patient between the age 30 to 65 years
3. Patient of both the gender
4. Patients who can understand English or Bengali
or Hindi
|
|
| ExclusionCriteria |
| Details |
1. Critically ill patients
2. Previous disability other than stroke
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve self awareness, functional activities and muscle among stroke patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="186" Sample Size from India="186"
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)
|
15/09/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This quantitative study will be done at IQ City Medical College Hospiital at OPD and IPD of medical department neurology department and physiotherapy department through quasiexperiemntal research design with186 stroke pateinebts to improve self awareness functional activities and muscle strength among stroke patients intervention of post stroke rehabilitation module which include cognitive rehabilitation training and task oriented exercise of upper extremity among stroke patients where exercise will be provided for 8 weeks one hour session three times per week with a minimum of 8 to 10 exercises per session. Cognitive exercises include auditory comprehension, daily activities, playing with coins, playing with card, playing with nuts and bolts, writing skill, memory recall, categorization exercises, time exercises, deductive reasoning, drawing figures, fine motor control, auditory attentionmathematical reasoning, recall of stories and events. Task oriented exercises include total three types of exercises. Firstly, arm stretching exercises like lifting the arm, extending the elbow, turning the fore arm, extending the fingers, extending the thumb, secondly, arm muscular strengthening exercises like lifting an object, extending the elbow, extending the wrist, opening the hand. Lastly, arm functional exercises include drawing a line, moving a bottle, using a spoon, dressing the hair, opening a bottle, holding a cup, turning on a cap, writing, turning pages, throwing a ball, throwing a ball to someone. |