StrokeNCT04728776
Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan
An observational study of Stroke, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Feb 2017to 7 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with severe neurological comorbidities
- Patients having communication difficulties, such as patients with global aphasia or reduced consciousness.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University Of Lahore Teaching Hospital
Lahore, Punjab Province
About this study
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
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1, A week after the first assessment and at discharge upto 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start6 Feb 2017
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728776
- Sponsor's protocol ID
- 293
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan
- ClinicalTrials.gov ID
- NCT04728776
- Acronym / sponsor ID
- 293
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with severe neurological comorbidities
- Patients having communication difficulties, such as patients with global aphasia or reduced consciousness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
5 secondary outcomes
Short-form 36, "Change" is being assessed
Time frame: Day 1, A week after the first assessment
Barthel Index, "Change" is being assessed
Time frame: 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
Modified Rivermead Mobility Index, "Change" is being assessed
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale 3.0 "Change" is being assessed (time frame: Day 1, A week after the first assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.