Clinical trial NCT05203081: Urdu Version of National Institutes of Health Stroke Scale: Reliability and Validity Study
Official title: Reliability and Validity of Urdu Version of National Institutes of Health Stroke Scale in Pakistani Stroke Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Urdu version of National Institute of Health Stroke Scale
Reliability and Validity Study.
Glasgow Coma Scale
Modified Rankin Scale
Barthel Index
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 225
Sex: ALL
Minimum age (years): 34
Maximum age (years): 97
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We targeted the Pakistani stroke population with post-stroke impairments in our study.

Brief summary: The goal of this study was to translate and culturally adapt NIHSS into Urdu language and to evaluate its reliability and validity in Pakistani stroke population. Also assess its correlation with Glasgow Coma Scale, Modified Rankin Scale and Barthel Index for severity and location of post-stroke impairment.

Detailed description: As per preceding commendation, NIHSS has been translated into Urdu language from its English version and adapted culturally in Pakistan. Among stroke population, NIHSS-U has been administered in 225 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consent forms. For testing inter-observer reliability and intra-observer reliability of NIHSS-U, GCS, mRS, and BI, questionnaires has been administered by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd administration. As for the 3rd administration, it has been carried out after seven days by the first observer (re-testing), for intra-observer assessment. SPSS software version 24 has been used for the purpose of data entry and analysis. Internal consistency has been analyzed with Cronbach alpha value. Test-retest reliability has been assessed by using an intraclass correlation coefficient (ICC). The NIHSS-U has evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria: Inclusion Criteria:

* Patients or the ones next to them who gave informed consent.
* Age ranges from 34 to 97 years.
* Patients undertake particular stroke therapy including endovascular treatment intravenous thrombolysis.

Exclusion Criteria:

* Impaired strength of muscles because of cognitive and orthopedic diseases.
* Patients with severe hepatic, and/or renal diseases.
* Patients with impaired cognition and memory problems.
* Patients whose consent was not given by themselves, their caretakers.

Primary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: 1st day
measure: Glasgow Coma Scale
timeFrame: 1st day
measure: Modified Rankin Scale
timeFrame: 1st day
measure: Barthel Index
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
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