| 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
|
|
|
Primary Sponsor
|
| Name |
Sharda University |
| Address |
Knowledge Park-III, Greater Noida-201310, UP,India |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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. |
|
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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
|
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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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