Clinical trial NCT04843254: Translation of Stroke Specific Quality of Life Questionnaire Into Local Languages of Pakistan
Official title: Reliability and Validity of Stroke Specific Quality of Life Scale in Local Languages of Pakistan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
SSQoL
Stroke Specific Quality of Life
Tool Translation
Validity
Reliability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 1125
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To meet inclusion criteria, participants diagnosed with stroke (sub-acute/chronic stage), clinically stable, between age 40-70 years and able to read and complete the local language version of SSQoL. Then patient response will be checked on the translated versions.

Brief summary: The aim of the present study is to translate the Stroke Specific Quality of Life Questionnaire into local languages of Pakistan along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from a stroke. No such study has been previously conducted in the Pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.

Detailed description: The stroke-Specific Quality of Life Scale is regarded as one of the most extensive and more commonly utilized patient-centred and self-reported measure of outcomes in the stroke population. The SS-QoL scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy. It covers a more extensive inclusion of capacities ordinarily influenced by stroke.

The Stroke Specific Quality of Life questionnaire, originally developed in English, has been translated into many languages to assess for its validity and reliability ever since, but not any of the Pakistani native versions are made or tested. Previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and have an insight into patient's health-related concerns post-stroke. Thus, it is imperative to translate this questionnaire into psychometrically sound versions of indigenous Pakistani languages such as Urdu, Punjabi, Sindhi, Balochi and Pashto. This may promote an easy understanding of the local population in Pakistan where the languages are spoken and will provide a valid measure of stroke-specific health outcomes to be clinically utilized by practitioners and researchers across the country.

Eligibility criteria: Inclusion Criteria:

* Patients post-stroke (sub-acute/chronic stage)
* Participants belonging to Urdu, Punjabi, Sindhi, Balochi and Pashto speaking class
* Patients should be capable to complete the questionnaire without any help.

Exclusion Criteria:

* Healthy population
* Patients at the acute stage of stroke/ TIA.
* Individuals diagnosed with conditions other than stroke.
* Individuals with language/ memory problems.
* Individuals with disability due to any structural/congenital cause.

Primary outcomes:
measure: Cross-Cultural Translation of Stroke Specific Quality of Life Scale into local languages of Pakistan
timeFrame: 6 months
Secondary outcomes:
measure: Reliability and Validity of translated versions
timeFrame: 6 months
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Physiotherapy Department WIRS
state: KPK
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.
citation: Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.
citation: Ganvir S, Harishch M, Kunde C. Validation of Marathi Version of Stroke-specific Quality of Life. Ann Indian Acad Neurol. 2018 Oct-Dec;21(4):290-293. doi: 10.4103/aian.AIAN_449_17.
citation: Sallam SA, Al-Khamis FA, Muaidi QI, Abdulla FA. Translation and validation of the stroke specific quality of life scale into Arabic. NeuroRehabilitation. 2019;44(2):283-293. doi: 10.3233/NRE-182552.
citation: Mahmoodi M, Safari A, Vossoughi M, Golbon-Haghighi F, Kamali-Sarvestani M, Ghaem H, Borhani-Haghighi A. Stroke specific quality of life questionnaire: Test of reliability and validity of the Persian version. Iran J Neurol. 2015 Apr 4;14(2):94-100.
citation: Lo SH, Chang AM, Chau JP. Establishing equivalence of a Chinese version of the stroke specific quality of life measure for stroke survivors. Disabil Rehabil. 2017 Jun;39(11):1079-1086. doi: 10.1080/09638288.2016.1178348. Epub 2016 May 23.