Using Longshi Scale and Barthel Index to Evaluate the Ability of Daily Living Activities in Stroke Survivors: a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The internal responsiveness of Barthel Index at discharge
研究概览
简要总结
The aim of this research was to compare the responsiveness of Barthel Index (BI) and Longshi Scale (LS) for assessing activities of daily living (ADL) in stroke survivors at different stage and we also aimed to observe changes of ADL score in stroke survivors over time.
详细描述
The whole experiment process has been supervised by a research assistant, and all the data collected are recorded on paper case report forms. The research assistant also takes charge of checking the consistency of data enter into the registry against predefined rules. Stroke survivors in Shenzhen Second People's Hospital have been invited to participate in this study and divide into three groups according to their duration of stroke (acute stroke, subacute stroke and chronic strike).
Data collection:
Baseline information was collected within 24 hours of admission. ADL of stroke survivors was assessed on admission, at discharge and 3 months after discharge.
Sample size calculation:
The sample size in this study was calculated according to the sample size calculation formula: n=[(µα+µβ)(µα+µβ)(1+1/k)p(1-p)]/(pe-pc)(pe-pc). Investigations in many places in China showed that varying degrees of dysfunction remain in 70%-80% of stroke survivors, and the disability rate is 30.2%-62.8%. In this reserach，p=(pe+kpc)/(1+k)，pe=0.3，pc =0.6, α=0.05，β=0.1, so µ0.05=1.6449，µ0.10=1.2816，thus the sample size in our study was n=47. We assume that 10% of them loss to follow-up, thus the sample size in our study was 52 in each group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •diagnosis of cerebral infraction or intracerebral hemorrhage
- •stable vital signs
排除标准
- •brain tumor, Parkinson's disease or active epilepsy within three months
- •impaired cognitive functions
- •participation in any other clinical study
结局指标
主要结局
The internal responsiveness of Barthel Index at discharge
时间窗: Baseline, 20 days after admission(discharge)
The internal responsiveness of Barthel Index is described using SES and SRM. Score of SES and SRM ranges from 0 to 1. Higher SES or SRM means better outcomes and SES or SRM \> 0.5 is considered to be sufficient.
The internal responsiveness of Longshi Scale at 3 months after discharge
时间窗: Baseline, 3 months after discharge
The internal responsiveness of Longshi Scale is described using standardized effect size (SES) and the standardized response mean (SRM). Score of SES and SRM ranges from 0 to 1. Higher SES or SRM means better outcomes and SES or SRM \> 0.5 is considered to be sufficient.
The internal responsiveness of Barthel Index at 3 months after discharge
时间窗: Baseline, 3 months after discharge
The internal responsiveness of Barthel Index is described using SES and SRM. Score of SES and SRM ranges from 0 to 1. Higher SES or SRM means better outcomes and SES or SRM \> 0.5 is considered to be sufficient.
The internal responsiveness of Longshi Scale at discharge
时间窗: Baseline, 20 days after admission(discharge)
The internal responsiveness of Longshi Scale is described using standardized effect size (SES) and the standardized response mean (SRM). Score of SES and SRM ranges from 0 to 1. Higher SES or SRM means better outcomes and SES or SRM \> 0.5 is considered to be sufficient.
次要结局
- Pearson correlation coefficient (r) between Longshi Scale and Barthel Index at discharge(Baseline, 20 days after admission(discharge))
- Pearson correlation coefficient (r) between Longshi Scale and Barthel Index at 3 months after discharge(Baseline, 3 months after discharge)
- Area under receiver operating characteristic curve of Longshi Scale at discharge(Baseline, 20 days after admission(discharge))
- Area under receiver operating characteristic curve of Longshi Scale at 3 months after discharge(Baseline, 3 months after discharge)
- Area under receiver operating characteristic curve of Barthel Index at discharge(Baseline, 20 days after admission(discharge))
- Area under receiver operating characteristic curve of Barthel Index at 3 months after discharge(Baseline, 3 months after discharge)
- Longshi Scale(Baseline, 20 days after admission(discharge) and 3 months after discharge)
- Barthel Index(Baseline, 20 days after admission(discharge) and 3 months after discharge)