- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04843254
Translation of Stroke Specific Quality of Life Questionnaire Into Local Languages of Pakistan
Reliability and Validity of Stroke Specific Quality of Life Scale in Local Languages of Pakistan
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ayesha Javed, MSPT(NMPT*)
- Phone Number: 03165278975
- Email: ayesha11492@gmail.com
Study Locations
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KPK
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Abbottabad, KPK, Pakistan, 22010
- Recruiting
- Physiotherapy Department WIRS
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Contact:
- Umber Fatima, M.Phil
- Phone Number: 03314721691
- Email: umber.fatima11@gmail.com
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Principal Investigator:
- Ayesha Javed, MSPT(NMPT*)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cross-Cultural Translation of Stroke Specific Quality of Life Scale into local languages of Pakistan
Time Frame: 6 months
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The Stroke Specific Quality of Life Scale (SSQoL) is regarded as one of the most extensive and more commonly utilized patient-centred and self-reported measure of outcomes in the stroke population.
It is a health-related stroke outcome measure intended to gather all the relevant concerns significant to the stroke population.
The responses are obtained via a progression of a series of centred meetings and interviews with concerned post-stroke patients to survey personal satisfaction.
The SS-QoL 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.
The patient responses are appraised on a Likert scale consisting of 5 points with greater scores demonstrating better capacity.
It covers a more extensive inclusion of capacities ordinarily influenced by stroke.
Its translation is to be done in the local languages of Pakistan through a rigorous and approved process.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reliability and Validity of translated versions
Time Frame: 6 months
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To determine reliability and validity of cross-culturally adapted and the translated versions of SSQoL in stroke patients with respective languages.
Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more interval between different visits of the patient and validity is how accurate the tool measures an item it is supposed to.
Thus these both are to measured through various parameters to validate the translated versions as appropriate and applicable.
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- REC/00960 Ayesha Javed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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