Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan

Study Overview
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Brief Summary
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BACKGROUND Knowledge about the perceived impact of stroke on survivors' lives is still scarce in Pakistan due to the lack of translated and culturally adapted self-rating scales. The stroke impact scale is a comprehensive self-reported outcome measure designed to assess the quality of life following the stroke. Although the psychometric properties of SIS found to be superior to the conventional generic quality of life scales, it has not been translated and tested in Pakistan. OBJECTIVE To translate and cross-culturally validate the Urdu version of stroke impact scale 3.0 for Pakistan MATERIAL AND METHODS Established guidelines were followed for translation and adaption of the Stroke impact scale 3.0. A prospective cohort of 116 patients with mild to moderate stroke self-reported their recovery on the Urdu version of SIS 3.0. The patients were concurrently evaluated on the established scales to assess the validity using the Spearman correlation coefficient. ANOVA was used to determine the discriminant validity. Ninety patients were consecutively re-evaluated to determine the test-retest reliability, precision, minimal detectable change (MCD) and clinically minimally important difference. The coefficients of ICC, Cronbach's alpha, and weighted kappa were calculated to establish the stability and consistency of the scale. The receiver operating curve was used to estimate the MCID of SIS-16 using global rating scale as an anchor. KEYWORDS: Stroke, Stroke Impact Scale, Outcome Measures, Quality of Life

Official Title
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Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute, subacute or chronic stroke Patients with hemorrhagic or ischemic or recurrent stroke attack Age of patients between 50-80 Ability to read and write Urdu with minimum education to 5th grade Exclusion Criteria: Patients with severe neurological comorbidities Patients having communication difficulties, such as patients with global aphasia or reduced consciousness.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale 3.0 Change is being assessed | A 59-item self-reported scale with 8 domains, scores of each domain range from 0 to 100, and higher scores indicate a better health-related quality of life | Day 1, A week after the first assessment | 
| Stroke Impact Scale-16 Change is being assessed | It consists of 16 items of 4 physical function. Its score varies from 0 to 100 and higher score indicates more functioning of the patient | Day 1, A week after the first assessment and at discharge upto 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-form 36, Change is being assessed | SF-36 is a generic HRQoL measure that includes 8 domains. Scores for each domain range from 0 to 100, and higher values indicate better function. | Day 1, A week after the first assessment | 
| Barthel Index, Change is being assessed | The Barthel Index used to evaluate activities of daily living in stroke patients measures and measures 10 basic aspects of activities of daily living related to self-care and mobility: control of bowels and bladder, grooming, toilet use, feeding, transfer, mobility, dressing, stairs, and bathing. Its score ranges from 0 to 100, and lower scores indicate greater dependency. | Day 1, A week after the first assessment | 
| Stroke Rehabilitation Assessment of Movement, Change is being assessed | Composed of 30 items, score range from 0-100, measures physical function and higher score indicates more physical functioning of patient | Day 1, A week after the first assessment | 
| Modified Rivermead Mobility Index, Change is being assessed | A 15-items scale with each item score range from 0 to 5. Its score varies from 0 to 100 and higher score indicates more functioning of the patient | Day 1, A week after the first assessment | 
| Global rating of change scale Change is being assessed | Measures self-perceived change in health status and the main purpose is to quantify the extent to which a patient has improved or deteriorated over time. Score lower than 0 means patient has deteriorated and more than 0 means patient has improved. Its score varies from -7 to +7 | at discharge up to 12 weeks only, Please note it simply ask the patient how much change he has experienced over the course of treatment period |