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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203081
• Other study ID #: REC-FSD-00235
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: January 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Years to 97 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. Epub 2007 Feb 1. Review. — View Citation

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. — View Citation

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. Epub 2004 Feb 19. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2005 Sep 16. — View Citation

Wisniewski A, Filipska K, Puchowska M, Piec K, Jaskólski 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale	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).	1st day
Primary	Glasgow Coma Scale	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	1st day
Primary	Modified Rankin Scale	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.	1st day
Primary	Barthel Index	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.	1st day