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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04728776
Enrollment
116
Registered
2021-01-28
Start date
2017-02-06
Completion date
2020-02-07
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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

Interventions

None listed

Sponsors

University of Lahore
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Age
50 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stroke Impact Scale-16 Change is being assessedDay 1, A week after the first assessment and at discharge upto 12 weeksIt consists of 16 items of 4 physical function. Its score varies from 0 to 100 and higher score indicates more functioning of the patient
Stroke Impact Scale 3.0 Change is being assessedDay 1, A week after the first assessmentA 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

Secondary

MeasureTime frameDescription
Barthel Index, Change is being assessedDay 1, A week after the first assessmentThe 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.
Stroke Rehabilitation Assessment of Movement, Change is being assessedDay 1, A week after the first assessmentComposed of 30 items, score range from 0-100, measures physical function and higher score indicates more physical functioning of patient
Global rating of change scale Change is being assessedat discharge up to 12 weeks only, Please note it simply ask the patient how much change he has experienced over the course of treatment periodMeasures 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
Modified Rivermead Mobility Index, Change is being assessedDay 1, A week after the first assessmentA 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
Short-form 36, Change is being assessedDay 1, A week after the first assessmentSF-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.

Other

MeasureTime frameDescription
Hospital Anxiety and Depression Scale, Change is being assessedDay 1, A week after the first assessment, at discharge upto 12 weekThe Hospital Anxiety and Depression Scale is 14 items scale for assessment of anxiety and depression. Scale consists of 7 items for depression and 7 items for depression and each item scored from 0 (no problem) to 3 (severe problem). Scores on individual items can be summed to calculate a score for anxiety and for depression and higher score is indicative of more depression and anxiety. Score of each sub scale varies from 0-21, where 0-7 means normal, 8-10 means mild, 11-14 means moderate, 15-21 means sever disorder.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026