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Completed

NCT Number: NCT04728776

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

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Key information

Conditions

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

Age range

50 year–80 year

Study type

Observational

Primary location

The University Of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Stroke Impact Scale 3.0 "Change" is being assessed

    Time frame: Day 1, A week after the first assessment

    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

  2. Stroke Impact Scale-16 "Change" is being assessed

    Time frame: Day 1, A week after the first assessment and at discharge upto 12 weeks

    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

Secondary outcomes

  1. Short-form 36, "Change" is being assessed

    Time frame: Day 1, A week after the first assessment

    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.

  2. Barthel Index, "Change" is being assessed

    Time frame: Day 1, A week after the first assessment

    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.

  3. Stroke Rehabilitation Assessment of Movement, "Change" is being assessed

    Time frame: Day 1, A week after the first assessment

    Composed of 30 items, score range from 0-100, measures physical function and higher score indicates more physical functioning of patient

  4. Modified Rivermead Mobility Index, "Change" is being assessed

    Time frame: Day 1, A week after the first assessment

    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

  5. Global rating of change scale "Change" is being assessed

    Time frame: 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

    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

Other outcomes

  1. Hospital Anxiety and Depression Scale, "Change" is being assessed

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

    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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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