Urdu Version of National Institutes of Health Stroke Scale: Reliability and Validity Study

Completed

• Conditions: Stroke

• Registration Number: NCT05203081
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2021-05-30
• Study First Submitted: 2021-06-02
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-15
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-21
• Last Update Submitted: 2022-01-21
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Scale	1st day	Glasgow Coma Scale is employed for patients suffering from head injury and has three components: eye opening, verbal response, and motor response. Score ranges from 3-15, lower score stands worse outcome
Barthel Index	1st day	Barthel Index is use to assess the level of independence and autonomy of stroke patient in performing ADLs. It is a list of 10 elementary ADLs: feeding, grooming, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers, and stair climbing. The activities are rated through time taken and assistance used by patient. Score ranges from 0-100.
Modified Rankin Scale	1st day	Modified Rankin Scale is use to assess the degree of remaining disabilities while recovering from stroke. In mRS, 0-6 levels stands as; "0" for no symptom at all, "1" for no significant disability, "2" for slight disability, "3" for moderate disability, "4" for moderately severe disability, "5" for severe disability, and "6" for dead.
National Institutes of Health Stroke Scale	1st day	The National Institutes of Health Stroke Scale is a standardised evaluation tool for determining the neurological impairments that are most often encountered in acute stroke patients. It measures awareness, vision, visual fields, facial weakness, extremity motor performance, sensory deficiency, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).

Trial Locations

Locations (1)

Ripah International University; 🇵🇰 Faisalabad, Punjab, Pakistan