StrokeNCT06043856
Translation and Psychometric Analysis of the Urdu Version of Stroke Specific Quality of Life Scale
An observational study of Stroke and Stroke, Ischemic, run by University of Lahore at 1 site in Pakistan.
Trial summary
Stroke is a leading cause of adult disability worldwide, ranking as the third major cause of mortality in wealthy nations and the second in developing ones. When adapting a questionnaire for use in a different cultural context, a process called "cross-cultural adaptation" considers linguistic and cultural nuances. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke, Stroke, Ischemic, Quality of Life
- How many people
- 147 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2021to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Adult, Older adult
Study population: Diagnosed Stroke Population within range of 35-65 years and possessed the ability to comprehend and communicate verbally in the Urdu language.
Who may be able to join
- Diagnosed stroke patients
- Age between 35 to 65 years 47
- Patients should understand and can verbally communicate in Urdu
Who cannot join
- Patient with other neurological conditions like parkinson, Alzheimer, Dementia etc
- Unconscious patient
- Patients with musculoskeletal and orthopedic conditions that affect upper and lower extremities function
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 55150
About this study
Official title: Translation, Cultural Adaptation and Psychometric Analysis of Urdu Version of Stroke Specific Quality of Life Scale in Stroke Patients
Stroke is a leading cause of adult disability worldwide, ranking as the third major cause of mortality in wealthy nations and the second in developing ones. When adapting a questionnaire for use in a different cultural context, a process called "cross-cultural adaptation" considers linguistic and cultural nuances. Guidelines outline the standard procedure to translate, assess psychometric properties, and culturally adapt questionnaires for new populations.
The Stroke Specific Quality of Life (SS-QOL), designed for self-administration, requires no training. Research indicates its accuracy in assessing stroke victims over the phone, with completion taking 10 to 15 minutes. Scores on the SS-QOL scale correlate with improved functioning. Internal consistency, measured by Cronbach's alpha, ranged from satisfactory to outstanding in stroke patients, indicating good reliability.
This study aims to fill a gap by translating the SS-QOL questionnaire into Urdu, facilitating culturally adapted assessments. Validating scores within the Pakistani population will establish the reliability and effectiveness of the Urdu version, addressing a literature gap in stroke-related quality of life assessments among Urdu speakers in Pakistan. This research aims to provide valuable insights and a comprehensive tool for clinical setups in diverse settings, urban or rural. Introducing a standardized gold standard test will enable healthcare professionals to confidently diagnose and prognose stroke patients. The SS-QOL questionnaire, with its 49 self-report items covering 12 energy-related domains, promises to enhance understanding of stroke's impact on the quality of life among Urdu speakers.
Read the detailed description
A cross-sectional study was conducted on 147 stroke patients at the Physiotherapy Department of the University of Lahore Teaching Hospital, situated on Defense Road, Lahore. The study spanned nine months following the approval of the research synopsis. Participant selection utilized a non-probability convenient sampling technique. The inclusion criteria comprised stroke-diagnosed patients aged between 35 to 65 years, proficient in verbal Urdu communication. Patients with neurological conditions like Parkinson's disease, Alzheimer's disease, or dementia, as well as unconscious individuals, were excluded. Additionally, patients with musculoskeletal or orthopedic conditions potentially affecting upper and lower extremity functioning were also excluded.
Written informed consent was obtained from all patients, and approval was secured from the Ethics Committee of the University of Lahore. The translated Urdu version of the SS-QOL questionnaire underwent a four-step procedure. Initially, two native Urdu speakers independently translated the SS-QOL into Urdu, with one possessing medical expertise and the other from a non-medical background. Their translations were merged into a single version. This combined version was then translated back into English by two professional translators unfamiliar with the questionnaire and medical terminology to ensure consistent English translation.
A research committee, comprising physiotherapists, an orthopedic surgeon, translators, a language expert, and authors, held a meeting to assess all versions of the SS-QOL for alignment with Urdu cultural nuances and methodological accuracy. After methodological and grammatical analysis, a pre-final SS-QOL version was approved by the committee. Seventy patients confirmed their comprehension of the questions through pilot testing, and their feedback was deliberated upon by the authors. Subsequently, a final Urdu version of the SS-QOL was established.
- Conditions
- Stroke, Stroke, Ischemic, Quality of Life
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 12 (SF-12)
The SF-12, or Short Form-12, is a widely used self-reported questionnaire used to assess health-related quality of life (HRQOL). It is a shorter version of the SF-36 (Short Form-36), which is a more extensive health survey. The SF-12 is designed to be a concise tool for measuring various aspects of a person's physical and mental health. The SF-12 questionnaire generates two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores provide a way to interpret the overall health-related quality of life of an individual.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Dec 2021
- Primary completion10 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Maria Hira, MSPTN, Principal investigator, University of LahoreUmair Ahmed, PhD PT, Study director, University of LahoreHafiza Sana Ashraf, MSPT MSK, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043856
- Sponsor's protocol ID
- IRB-UOL-FAHS/1083/2021
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cultural Adaptation and Psychometric Analysis of Urdu Version of Stroke Specific Quality of Life Scale in Stroke Patients
- ClinicalTrials.gov ID
- NCT06043856
- Acronym / sponsor ID
- IRB-UOL-FAHS/1083/2021
- Conditions
- Stroke, Stroke, Ischemic, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a leading cause of adult disability worldwide, ranking as the third major cause of mortality in wealthy nations and the second in developing ones. When adapting a questionnaire for use in a different cultural context, a process called "cross-cultural adaptation" considers linguistic and cultural nuances. Guidelines outline the standard procedure to translate, assess psychometric properties, and culturally adapt questionnaires for new populations.
The Stroke Specific Quality of Life (SS-QOL), designed for self-administration, requires no training. Research indicates its accuracy in assessing stroke victims over the phone, with completion taking 10 to 15 minutes. Scores on the SS-QOL scale correlate with improved functioning. Internal consistency, measured by Cronbach's alpha, ranged from satisfactory to outstanding in stroke patients, indicating good reliability.
This study aims to fill a gap by translating the SS-QOL questionnaire into Urdu, facilitating culturally adapted assessments. Validating scores within the Pakistani population will establish the reliability and effectiveness of the Urdu version, addressing a literature gap in stroke-related quality of life assessments among Urdu speakers in Pakistan. This research aims to provide valuable insights and a comprehensive tool for clinical setups in diverse settings, urban or rural. Introducing a standardized gold standard test will enable healthcare professionals to confidently diagnose and prognose stroke patients. The SS-QOL questionnaire, with its 49 self-report items covering 12 energy-related domains, promises to enhance understanding of stroke's impact on the quality of life among Urdu speakers.
Detailed description
A cross-sectional study was conducted on 147 stroke patients at the Physiotherapy Department of the University of Lahore Teaching Hospital, situated on Defense Road, Lahore. The study spanned nine months following the approval of the research synopsis. Participant selection utilized a non-probability convenient sampling technique. The inclusion criteria comprised stroke-diagnosed patients aged between 35 to 65 years, proficient in verbal Urdu communication. Patients with neurological conditions like Parkinson's disease, Alzheimer's disease, or dementia, as well as unconscious individuals, were excluded. Additionally, patients with musculoskeletal or orthopedic conditions potentially affecting upper and lower extremity functioning were also excluded.
Written informed consent was obtained from all patients, and approval was secured from the Ethics Committee of the University of Lahore. The translated Urdu version of the SS-QOL questionnaire underwent a four-step procedure. Initially, two native Urdu speakers independently translated the SS-QOL into Urdu, with one possessing medical expertise and the other from a non-medical background. Their translations were merged into a single version. This combined version was then translated back into English by two professional translators unfamiliar with the questionnaire and medical terminology to ensure consistent English translation.
A research committee, comprising physiotherapists, an orthopedic surgeon, translators, a language expert, and authors, held a meeting to assess all versions of the SS-QOL for alignment with Urdu cultural nuances and methodological accuracy. After methodological and grammatical analysis, a pre-final SS-QOL version was approved by the committee. Seventy patients confirmed their comprehension of the questions through pilot testing, and their feedback was deliberated upon by the authors. Subsequently, a final Urdu version of the SS-QOL was established.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diagnosed Stroke Population within range of 35-65 years and possessed the ability to comprehend and communicate verbally in the Urdu language.
Key inclusion criteria (3 listed)
- Diagnosed stroke patients
- Age between 35 to 65 years 47
- Patients should understand and can verbally communicate in Urdu
Key exclusion criteria (3 listed)
- Patient with other neurological conditions like parkinson, Alzheimer, Dementia etc
- Unconscious patient
- Patients with musculoskeletal and orthopedic conditions that affect upper and lower extremities function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short Form 12 (SF-12)
Time frame: 1 week
The SF-12, or Short Form-12, is a widely used self-reported questionnaire used to assess health-related quality of life (HRQOL). It is a shorter version of the SF-36 (Short Form-36), which is a more extensive health survey. The SF-12 is designed to be a concise tool for measuring various aspects of a person's physical and mental health. The SF-12 questionnaire generates two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores provide a way to interpret the overall health-related quality of life of an individual.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafiza Maria Hira, MSPTN principal investigator
University of Lahore
Umair Ahmed, PhD PT study director
University of Lahore
Hafiza Sana Ashraf, MSPT MSK study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke, Ischemic, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 12 (SF-12) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.