| CTRI Number |
CTRI/2025/07/090932 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hindi Stroke Specific Quality Of Life Scale. |
|
Scientific Title of Study
|
Hindi Translation and Cross Cultural Adaptation of Stroke Specific Quality of Life Scale in Stroke Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanskriti Srivastava |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU,Mullana, Ambala, Haryana |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room No. 01, Mullana, Ambala, 133207,Haryana
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor Room No. 01, Mullana, Ambala, Haryana, 133207
Ambala
HARYANA
133207
India |
| Phone |
8198015310 |
| Fax |
|
| Email |
physioo.19bpt1116@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanika |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor Room No. 01, Mullana, 133207,Haryana, India
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor Room No. 01, Mullana, 133207,Haryana, India
Ambala
HARYANA
133207
India |
| Phone |
7015597126 |
| Fax |
|
| Email |
kanika.k160@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanskriti Srivastava |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor Room No. 01, Mullana, 133207, Haryana, India
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor Room No. 01, Mullana, 133207, Haryana, India
Ambala
HARYANA
133207
India |
| Phone |
8198015310 |
| Fax |
|
| Email |
physioo.19bpt1116@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanskriti Srivastava |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MMDU, Mullana, 133207,Haryana |
| Type of Sponsor |
Other [Medical University] |
|
|
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 Kanika |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,MMDU,Mullana,133207,Ambala |
Neuro Physiotherapy OPD, Ground Floor Room No. 01, Maharishi Markandeshwar Deemed To be University, Mullana, Haryana
Ambala
HARYANA |
7015597126
kanika.k160@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.First ever Stroke.
2.Any type of Stroke.
3.Individuals with basic understanding of Hindi language.
|
|
| ExclusionCriteria |
| Details |
1. Un-cooperative patients.
2. Patients with any cognitive impairments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stroke Specific Quality of Life Scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke specific quality of life scale |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
08/08/2025 |
| 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
|
|
Brief Summary
|
This study aims to translate, cross-culturally adapt, and validate the Stroke-Specific Quality of Life (SS-QOL) scale into Hindi, as no Hindi version currently exists despite its wide use in other languages. Using Beaton’s standardized guidelines, the English version will be translated by two independent translators from medical and non-medical backgrounds. A panel of experts will review the translation through the Delphi method. The pre-final version will then be tested on stroke patients to assess clarity and cultural relevance. Finally, the Hindi version’s validity and reliability will be evaluated through a cross-sectional study. |