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CTRI Number  CTRI/2025/08/093373 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Improving perceived self-efficacy and autonomy in stroke survivors: An Interventional study 
Scientific Title of Study   Perceived Self-Efficacy and Autonomy in Stroke Survivors: An Interventional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gita Jyoti Ojha 
Designation  Research Scholar and Occupational therapist 
Affiliation  Sharda University 
Address  Research Scholar, Block -4, Sharda School of Humanities and Social Sciences, Knowledge Park-III, Greater Noida-201310, UP, India
Research Scholar, Block-4 Sharda School of Humanities and Social Sciences, Knowledge Park-III, Greater Noida-201310, UP, India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  09560246144  
Fax    
Email  2023204140.gita@dr.sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Toran Talwar 
Designation  Assistant Professor Of Psychology 
Affiliation  Sharda University 
Address  Room no 207 B (IQAC),2nd Floor,Block 2, Ext - 2935, Sharda University, Knowledge Park-III, Greater Noida-201310, UP, India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  09350828430  
Fax    
Email  toran.talwar@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Gita Jyoti Ojha 
Designation  Research Scholar 
Affiliation  Sharda University 
Address  Research Scholar, Block -4, Sharda School of Humanities and Social Sciences, Knowledge Park-III, Greater Noida-201310, UP, India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  09560246144  
Fax    
Email  2023204140.gita@dr.sharda.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sharda University 
Address  Knowledge Park-III, Greater Noida-201310, UP,India 
Type of Sponsor  Research institution and hospital 
 
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 Toran Talwar  Sharda School of Humanities and Social sciences   Room no. 804, 8th Floor,Block 7, SSHSS,Sharda University Campus,Knowledge Park-III, Greater Noida-201310, UP,India
Gautam Buddha Nagar
UTTAR PRADESH 
09350828430

toran.talwar@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, School of Medical Sciences and Research, Sharda University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I698||Sequelae of other cerebrovasculardiseases, (2) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, (3) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, (4) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere, (5) ICD-10 Condition: I678||Other specified cerebrovascular diseases, (6) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, (7) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (8) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries, (9) ICD-10 Condition: I635||Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Self-efficacy intervention  Behavioural Intervention based on Banduras self efficacy model. 
Comparator Agent  conventional therapy  conventional therapy (including physiotherapy, occupational therapy, etc.) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Persons with stroke within 2 years of the event. They should be willing to participate in the study. Score more than 24 in MMSE/MOCA  
 
ExclusionCriteria 
Details  1) Medically unstable
2) Persons with stroke after 2 years of onset
3) With cognitive impairment, clinical depression, aphasia, or other co-morbidities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) change in perceived self efficacy in stroke survivors as measured by SSEQ ( stroke self efficacy questionnaire).
2) changes in autonomy in stroke survivors as measured by IPAQ ( impact on participation and autonomy questionnaire in stroke survivors. 
At baseline , after intervention of 8 weeks and follow up at 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Functional status as measured by barthel index  Baseline, after intervention in 8 weeks and follow up at 12 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   10/09/2025 
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="0"
Months="9"
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 has a substantial worldwide impact on mortality and morbidity, and despite advancements in medical care, long-term rehabilitation presents difficulties. The purpose of this study is to investigate how self-efficacy therapies affect stroke patients’ views of their own efficacy and autonomy in order to enhance their capacity for self-monitoring their health. Self-efficacy affects patients’ confidence and autonomy, which improves outcomes post-stroke. With a foundation in social cognitive theory, the goal of this project is to study the self-efficacy intervention program that will boost stroke survivors’ autonomy and sense of self. The study design is a pre-post interventional study. Participants will be recruited following  convenient sampling.  Stroke survivors (sample size of 72 nos.) of both genders and age more than 18 years would be enrolled after they meet the inclusion criteria and provide consent for participation in the study.  Assessments would be done using standardized tools like (SSEQ, IPAQ and Barthel index) at different time points. After baseline assessment, the intervention sessions based on Bandura’s self-efficacy model including 4 components: personal achievements leading to mastery, learning from others’ experiences (modeling), receiving encouragement and persuasion, and managing physiological responses would be administered for 8 weeks, followed by post-intervention assessment and a follow up assessment at 3 months/12 weeks duration. The insights gained from this research could help understand how self-efficacy influences the function of a stroke survivor, leading to the development of targeted rehabilitation programs to improve the quality of life and autonomy of individuals affected by stroke.

 

 
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