| CTRI Number |
CTRI/2025/01/079370 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Gujarati Translation and Validation of the Stroke Self-Efficacy Questionnaire in Chronic Stroke Patients |
|
Scientific Title of Study
|
Gujarati Translation and psychometric testing of the stroke self-efficacy questionnaire in patients with chronic stroke: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Vipul Desai |
| Designation |
MPT Student |
| Affiliation |
S.S. Agrawal Institute of Physiotherapy and Medical Care Education, Navsari. |
| Address |
Neuro out patient department, ground floor, s.s. agrawal institute of physiotherapy, agrawal college campus, verranjali marg 1 ,devina
park,navsari.
Navsari
GUJARAT
396445
India |
| Phone |
8849264614 |
| Fax |
|
| Email |
28desaisakshi28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr jagruti patel |
| Designation |
assistant professor, PG Guide and Phd scholar |
| Affiliation |
S.S. Agrawal Institute of Physiotherapy and Medical Care Education, Navsari. |
| Address |
agrawal college campus, veeranjali 1 marg, devina park, navsari.
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Vipul Desai |
| Designation |
MPT Student |
| Affiliation |
S.S. Agrawal Institute of Physiotherapy and Medical Care Education, Navsari. |
| Address |
agrawal college campus, veeranjali 1 marg, devina
park, navsari.
Navsari
GUJARAT
396445
India |
| Phone |
8849264614 |
| Fax |
|
| Email |
28desaisakshi28@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S agrawal institute of physiotherapy and medical care education, navsari, gujarat. 396445
agrawal college campus, out patient department, verranjali 1 marg, devina park, navsari 396445 Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Sakshi Desai |
| Address |
5 Geet Govind Appartment , Haveli street, Mota Bazaar, Navsari 396445 Gujarat India. |
| 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 Shlesha Vaidya |
S.S. Agrawal Institute of Physiotherapy and Medical Care Education, Navsari. |
department of
physiotherapy,ground
floor, agrawal college
campus, viranjali van
marg, devina park,
navsari
Navsari
GUJARAT
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE S.A AGRAWAL INSTITUTE OF PHYSIOTHERAPY AND MEDICAL CARE EDUCATION |
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: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CROSS-SECTIONAL STUDY |
This study will be taken place in two phases
Phase I Translation Process
The Gujarati translation of The stroke self efficacy questionnaire was done following the Beaton’s guidelines by the steps given below
Stage I: Initial Translation
The forward translation is the initial step in the adaption process in which the instrument is translated twice from the original source language (English) to the target language (Gujarati) . two bilingual translators whose mother tongue is the target language (Gujarati), create two independent translations.
Each translator creates a written report on the translation they have completed. Additional remarks are provided to emphasize difficult phrases or uncertainty.
Stage II: Synthesis of The Translations
The recording observer synthesizes the translated scale, which has been translated by both translators T1 and T2.synthesizing the original version of the SSEQ scale.
Stage III: Back Translation
In this step two bilingual translators whose mother tongue is the source language or an professional in literature The major reasons for translating the questionnaire (T-12) are avoiding information bias and eliciting unexpected meanings.
Stage IV: Expert Committee
A team of expert committee will review , discuss and After correcting any inconsistencies, a pre-final version (in Gujarati) will be created.
Stage V: Test of the Prefinal Version
Before finalizing the adapted scale a pilot will be conducted to ensure the validity, understanding and proper adaptation of the scale in patients with stroke.
Stage VI : Documentation
After completing each step final documentation Data from each stage will be collected and given to the original questionnaires developer
Phase II ASSESSING THE Psychometric VALUES
After competition of translation process the Psychometric properties by checking the Reliability and validity |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Stroke diagnosed with CT/MRI reports or ascertained by qualified medical professionals
6 months post-stroke
Age of 35-65 patients diagnosed with hemorrhagic or ischemic stroke
Both Gendre Male and Female
Have a Mini-Mental State Examination score more than 24
Patient who are able to speak and understand Gujarati
|
|
| ExclusionCriteria |
| Details |
Neurological deficits other than stroke
Aphasia
Dysarthria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stroke Impact Scale – Gujarati Version |
The patient will complete the translated scale, which will be administered again 48 hours later to assess its reliability. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/01/2025 |
| 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)
|
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
|
AIM AND OBJECTIVE To translate and the Stroke Self Efficacy Questionnaire (SSEQ) into the Gujarati language. To determine the inter-rater reliability of the Gujarati version of SSEQ. To determine the test-retest reliability of the Gujarati version of SSEQ. To determine the Face validity of the Gujarati version of SSEQ To determine the content validity of the Gujarati version of SSEQ. To determine the Criterion validity of the Gujarati version of SSEQ. |