Clinical trial NCT04728776: Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan
Official title: Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 116
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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


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.

Primary outcomes:
measure: Stroke Impact Scale 3.0 "Change" is being assessed
timeFrame: Day 1, A week after the first assessment
measure: Stroke Impact Scale-16 "Change" is being assessed
timeFrame: Day 1, A week after the first assessment and at discharge upto 12 weeks
Secondary outcomes:
measure: Short-form 36, "Change" is being assessed
timeFrame: Day 1, A week after the first assessment
measure: Barthel Index, "Change" is being assessed
timeFrame: Day 1, A week after the first assessment
measure: Stroke Rehabilitation Assessment of Movement, "Change" is being assessed
timeFrame: Day 1, A week after the first assessment
measure: Modified Rivermead Mobility Index, "Change" is being assessed
timeFrame: Day 1, A week after the first assessment
measure: Global rating of change scale "Change" is being assessed
timeFrame: 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:
measure: Hospital Anxiety and Depression Scale, "Change" is being assessed
timeFrame: Day 1, A week after the first assessment, at discharge upto 12 week
Locations:
city: Lahore
country: Pakistan
facility: The University Of Lahore Teaching Hospital
state: Punjab
Study officials:
References: