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

January 23, 2021 updated by: University of Lahore

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 1, A week after the first assessment
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
Day 1, A week after the first assessment and at discharge upto 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 1, A week after the first assessment
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.
Day 1, A week after the first assessment
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
Day 1, A week after the first assessment
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
Day 1, A week after the first assessment
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 1, A week after the first assessment, at discharge upto 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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