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临床试验/NCT04728776
NCT04728776已完成不适用

Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan

University of Lahore1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2017年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Stroke Impact Scale 3.0 "Change" is being assessed

研究概览

简要总结

BACKGROUND Knowledge about the perceived impact of stroke on survivors' lives is still scarce in Pakistan due to the lack of translated and culturally adapted self-rating scales. The stroke impact scale is a comprehensive self-reported outcome measure designed to assess the quality of life following the stroke. Although the psychometric properties of SIS found to be superior to the conventional generic quality of life scales, it has not been translated and tested in Pakistan.

OBJECTIVE To translate and cross-culturally validate the Urdu version of stroke impact scale 3.0 for Pakistan MATERIAL AND METHODS Established guidelines were followed for translation and adaption of the Stroke impact scale 3.0. A prospective cohort of 116 patients with mild to moderate stroke self-reported their recovery on the Urdu version of SIS 3.0. The patients were concurrently evaluated on the established scales to assess the validity using the Spearman correlation coefficient. ANOVA was used to determine the discriminant validity. Ninety patients were consecutively re-evaluated to determine the test-retest reliability, precision, minimal detectable change (MCD) and clinically minimally important difference. The coefficients of ICC, Cronbach's alpha, and weighted kappa were calculated to establish the stability and consistency of the scale. The receiver operating curve was used to estimate the MCID of SIS-16 using global rating scale as an anchor.

KEYWORDS: Stroke, Stroke Impact Scale, Outcome Measures, Quality of Life

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
接受健康志愿者
否

入选标准

  • •Patients with acute, subacute or chronic stroke
  • •Patients with hemorrhagic or ischemic or recurrent stroke attack
  • •Age of patients between 50-80
  • •Ability to read and write Urdu with minimum education to 5th grade

排除标准

  • •Patients with severe neurological comorbidities
  • •Patients having communication difficulties, such as patients with global aphasia or reduced consciousness.

结局指标

主要结局

Stroke Impact Scale 3.0 "Change" is being assessed

时间窗: Day 1, A week after the first assessment

A 59-item self-reported scale with 8 domains, scores of each domain range from 0 to 100, and higher scores indicate a better health-related quality of life

Stroke Impact Scale-16 "Change" is being assessed

时间窗: Day 1, A week after the first assessment and at discharge upto 12 weeks

It consists of 16 items of 4 physical function. Its score varies from 0 to 100 and higher score indicates more functioning of the patient

次要结局

  • Barthel Index, "Change" is being assessed(Day 1, A week after the first assessment)
  • Stroke Rehabilitation Assessment of Movement, "Change" is being assessed(Day 1, A week after the first assessment)
  • Global rating of change scale "Change" is being assessed(at discharge up to 12 weeks only, Please note it simply ask the patient how much change he has experienced over the course of treatment period)
  • Short-form 36, "Change" is being assessed(Day 1, A week after the first assessment)
  • Modified Rivermead Mobility Index, "Change" is being assessed(Day 1, A week after the first assessment)

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Sponsor

研究点 (1)

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