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

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

Study Overview

• Status: Completed
• Conditions: Stroke

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • The University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute, subacute or chronic stroke-hemorrhagic or ischemic or recurrent stroke attack, age of patients between 50-80 and the ability to read and write Urdu with minimum education to 5th grade. Patients were not enrolled in the study if they presented with severe neurological comorbidities and communication difficulties, such as patients with global aphasia or reduced consciousness.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale, "Change" is being assessed	The 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.	Day 1, A week after the first assessment, at discharge upto 12 week

Collaborators and Investigators

• Sponsor: University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No