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临床试验/NCT05203081
NCT05203081已完成不适用

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

Riphah International University1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2021年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
225
试验地点
1
主要终点
Glasgow Coma Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
34 Years 至 97 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Glasgow Coma Scale

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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