- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06043856
Translation and Psychometric Analysis of the Urdu Version of Stroke Specific Quality of Life Scale
Translation, Cultural Adaptation and Psychometric Analysis of Urdu Version of Stroke Specific Quality of Life Scale in Stroke Patients
Study Overview
Status
Conditions
Detailed Description
A cross-sectional study was conducted on 147 stroke patients at the Physiotherapy Department of the University of Lahore Teaching Hospital, located on Defense Road, Lahore. The study was completed within a span of 9 months following the approval of the research synopsis. A non-probability convenient sampling technique was employed for participant selection. The inclusion criteria encompassed patients who had been diagnosed with stroke, were aged between 35 to 65 years, and possessed the ability to comprehend and communicate verbally in the Urdu language. Conversely, patients with other neurological conditions such as Parkinson's disease, Alzheimer's disease, or dementia, as well as unconscious individuals, were excluded from the study. Additionally, patients with musculoskeletal and orthopedic conditions that could potentially impact the functioning of their upper and lower extremities were also excluded.
All patients provided written informed consent, and approval was obtained from the Ethics Committee of the University of Lahore. The translated Urdu version of the SS-QOL questionnaire was utilized for data collection, following a four-step procedure. Initially, two native Urdu speakers independently translated the SS-QOL into Urdu. One translator had medical expertise, while the other came from a non-medical background (T1, T2). Their translations were merged into a single version. Subsequently, this combined version was translated back into English by two professional translators (BT1, BT2) who were unfamiliar with the questionnaire and medical terminology, ensuring consistent English translation. A research committee comprising physiotherapists, an orthopedic surgeon, translators, a language expert, and authors held a meeting. This committee assessed all versions of the SS-QOL (T1, T2, T-12, BT1, BT2, B-12) for alignment with Urdu cultural nuances and methodological accuracy. They approved a pre-final SS-QOL version after methodological and grammatical analysis. Seventy patients confirmed their comprehension of the questions (pilot testing), and their feedback was deliberated upon by the authors. A final Urdu version of the SS-QOL was then established.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 55150
- University of Lahore Teaching hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed stroke patients
- Age between 35 to 65 years 47
- Patients should understand and can verbally communicate in Urdu
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form 12 (SF-12)
Time Frame: 1 week
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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.
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1 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hafiza Sana Ashraf, MSPT MSK, The University of Lahore
- Principal Investigator: Hafiza Maria Hira, MSPTN, The University of Lahore
- Study Director: Umair Ahmed, PhD PT, The University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/1083/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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