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

NCT ID: NCT05203081

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-30

Study Completion Date

2021-08-15

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

34 Years

Maximum Eligible Age

97 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Kashif

Role: STUDY_CHAIR

Riphah International University

Locations

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Ripah International University

Faisalabad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Wisniewski A, Filipska K, Puchowska M, Piec K, Jaskolski F, Slusarz R. Validation of a Polish version of the National Institutes of Health Stroke Scale: Do moderate psychometric properties affect its clinical utility? PLoS One. 2021 Apr 2;16(4):e0249211. doi: 10.1371/journal.pone.0249211. eCollection 2021.

Reference Type BACKGROUND
PMID: 33798218 (View on PubMed)

Sun TK, Chiu SC, Yeh SH, Chang KC. Assessing reliability and validity of the Chinese version of the stroke scale: scale development. Int J Nurs Stud. 2006 May;43(4):457-63. doi: 10.1016/j.ijnurstu.2005.07.004. Epub 2005 Sep 16.

Reference Type BACKGROUND
PMID: 16146632 (View on PubMed)

Zhang S, Chang C, Zhang J, Song B, Fang H, Xu Y. Correlation analysis of sleep quality and youth ischemic stroke. Behav Neurol. 2014;2014:246841. doi: 10.1155/2014/246841. Epub 2014 Aug 5.

Reference Type BACKGROUND
PMID: 25161340 (View on PubMed)

Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. doi: 10.1161/01.STR.0000258355.23810.c6. Epub 2007 Feb 1.

Reference Type BACKGROUND
PMID: 17272767 (View on PubMed)

Kwon S, Hartzema AG, Duncan PW, Min-Lai S. Disability measures in stroke: relationship among the Barthel Index, the Functional Independence Measure, and the Modified Rankin Scale. Stroke. 2004 Apr;35(4):918-23. doi: 10.1161/01.STR.0000119385.56094.32. Epub 2004 Feb 19.

Reference Type BACKGROUND
PMID: 14976324 (View on PubMed)

Nakao S, Takata S, Uemura H, Kashihara M, Osawa T, Komatsu K, Masuda Y, Okahisa T, Nishikawa K, Kondo S, Yamada M, Takahara R, Ogata Y, Nakamura Y, Nagahiro S, Kaji R, Yasui N. Relationship between Barthel Index scores during the acute phase of rehabilitation and subsequent ADL in stroke patients. J Med Invest. 2010 Feb;57(1-2):81-8. doi: 10.2152/jmi.57.81.

Reference Type BACKGROUND
PMID: 20299746 (View on PubMed)

Ohura T, Hase K, Nakajima Y, Nakayama T. Validity and reliability of a performance evaluation tool based on the modified Barthel Index for stroke patients. BMC Med Res Methodol. 2017 Aug 25;17(1):131. doi: 10.1186/s12874-017-0409-2.

Reference Type BACKGROUND
PMID: 28841846 (View on PubMed)

Hsueh IP, Lee MM, Hsieh CL. Psychometric characteristics of the Barthel activities of daily living index in stroke patients. J Formos Med Assoc. 2001 Aug;100(8):526-32.

Reference Type BACKGROUND
PMID: 11678002 (View on PubMed)

Quinn TJ, Langhorne P, Stott DJ. Barthel index for stroke trials: development, properties, and application. Stroke. 2011 Apr;42(4):1146-51. doi: 10.1161/STROKEAHA.110.598540. Epub 2011 Mar 3.

Reference Type BACKGROUND
PMID: 21372310 (View on PubMed)

Nik A, Sheikh Andalibi MS, Ehsaei MR, Zarifian A, Ghayoor Karimiani E, Bahadoorkhan G. The Efficacy of Glasgow Coma Scale (GCS) Score and Acute Physiology and Chronic Health Evaluation (APACHE) II for Predicting Hospital Mortality of ICU Patients with Acute Traumatic Brain Injury. Bull Emerg Trauma. 2018 Apr;6(2):141-145. doi: 10.29252/beat-060208.

Reference Type BACKGROUND
PMID: 29719845 (View on PubMed)

Other Identifiers

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REC-FSD-00235

Identifier Type: -

Identifier Source: org_study_id

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