Skip to main content
OpenTrials
Completed

NCT Number: NCT05203081

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

34 year–97 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. National Institutes of Health Stroke Scale

    Time frame: 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).

  2. Glasgow Coma Scale

    Time frame: 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

  3. Modified Rankin Scale

    Time frame: 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.

  4. Barthel Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Reliability and Validity of Urdu Version of National Institutes of Health Stroke Scale in Pakistani Stroke Population

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2022
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.