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

NCT ID: NCT04728776

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2020-02-07

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

Conditions

Stroke

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University Of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

293

Identifier Type: -

Identifier Source: org_study_id