Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06043856 |
| Other study ID # |
IRB-UOL-FAHS/1083/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 10, 2021 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Lahore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The leading cause of adult disability globally is stroke. Although stroke is rated as the
third major cause of mortality in wealthy nations, it is the second major cause of mortality
in developing nations. When creating a questionnaire for use in a different context, a
procedure known as "cross-cultural adaptation" takes into account both linguistic
(translation) and cultural adaption concerns. Beaten guidelines are standard to develop a
questionnaire into a new language, measure it's psychometric properties and culturally adapt
into a new population. By Williams, Weinberger, Harris, and Clark in 1999, the SS-QOL was
published and verified for the first time. Since the Stroke Specific quality of life (SS-QOL)
is meant to be self-administered, no training is necessary. According to one study, stroke
victims can be accurately measured using the scale over the phone. The SS-QOL scale may be
finished in 10 to 15 minutes. The SS QOL score increases with improved functioning.
Cronbach's alpha values varied from satisfactory (alpha = 0.75 for the work/productivity
subscale) to outstanding (alpha = 0.89 for self-care) in Williams' et al. (1999a)
investigation of the internal consistency of the SS-QOL in 34 stroke patients, indicating
that the SS-QOL has a good internal consistency. The present study endeavors to address this
gap by translating the Stroke Specific Quality of Life questionnaire into Urdu, enabling a
culturally adapted and accessible assessment tool. By assessing the validity of the obtained
scores within the Pakistani population, this study aims to establish the reliability and
effectiveness of the Urdu version. Consequently, this will serve to bridge the literature gap
in stroke-related quality of life assessments among Urdu speakers in Pakistan. In doing so,
this research strives to provide valuable insights and a comprehensive tool for clinical
setups across diverse settings, urban or rural. By introducing a standardized gold standard
test, healthcare professionals can confidently make accurate diagnoses and prognoses for
their stroke patients. The Stroke Specific Quality of Life questionnaire, with its 49
self-report items encompassing 12 energy-related domains, is poised to contribute
substantially to a more thorough understanding of stroke's impact on the quality of life
within the Urdu-speaking population.
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.
