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

NCT04728776 | Completed

• 1 other identifier: 293
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Short-form 36, "Change" is being assessed

  Day 1, A week after the first assessment

• Barthel Index, "Change" is being assessed

  Day 1, A week after the first assessment

• Stroke Rehabilitation Assessment of Movement, "Change" is being assessed

  Day 1, A week after the first assessment

• Modified Rivermead Mobility Index, "Change" is being assessed

  Day 1, A week after the first assessment

• Global rating of change scale "Change" is being assessed

  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 Outcomes (1)

• Hospital Anxiety and Depression Scale, "Change" is being assessed

  Day 1, A week after the first assessment, at discharge upto 12 week

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with severe neurological comorbidities
• Patients having communication difficulties, such as patients with global aphasia or reduced consciousness.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University Of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 28, 2021
• Study Start: February 6, 2017
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

PA (1)