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StrokeNCT05203081

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

An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 34 to 97 years
Conditions the study is for
Stroke
How many people
225 participants
Where
1 sitePakistan
Study dates
30 May 2021to 15 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 34 to 97 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: We targeted the Pakistani stroke population with post-stroke impairments in our study.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Ripah International University

    Faisalabad, Punjab Province, 38000

Other trials in Pakistan

About this study

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

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.

Read the 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.

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
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1st day

  2. 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

    Measured: 1st day

  3. 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.

    Measured: 1st day

  4. 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.

    Measured: 1st day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start30 May 2021
  3. Primary completion15 Aug 2021
  4. Study completion15 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203081
Sponsor's protocol ID
REC-FSD-00235
Status last verified
Jan 2022
First submitted
2 Jun 2021
Last updated
24 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33798218

  • 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.

    PubMed 16146632

  • 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.

    PubMed 25161340

  • 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.

    PubMed 17272767

  • 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.

    PubMed 14976324

  • 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.

    PubMed 20299746

  • 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.

    PubMed 28841846

  • 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.

    PubMed 11678002

  • 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.

    PubMed 21372310

  • 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.

    PubMed 29719845

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale (time frame: 1st day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05203081, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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