Comparing the Responsiveness of Barthel Index and Longshi Scale in Assessing the ADL of Stroke Survivors

Stroke Clinical Trial

Official title:

Using Longshi Scale and Barthel Index to Evaluate the Ability of Daily Living Activities in Stroke Survivors: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150743
• Other study ID #: 20210219006-FS01
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Statistical analysis:

1. Internal responsiveness First, standardized effect size (SES) was calculated by dividing the mean change in score between admission and discharge assessments by the standard deviation (SD) of the admission score. second, the standardized response mean (SRM) was obtained by dividing the mean change scores by the SD of the change score between admission and discharge scores. A value of SES or SRM>0.8 was large, 0.5 to 0.8 moderate, and 0.2 to 0.5 small.

2. External responsiveness The pearson correlation coefficient (r) was used to investigate the external responsiveness. An r value >0.75 represented good to excellent association; values of 0.50 to 0.75, moderate to good association; values of 0.25 to 0.50, fair association; and values ≤0.25, little association between the changes in scores on these measures. And the significance threshold was set at 0.05.

3. Receiver operating characteristic (ROC) curve For this study, the area under ROC curve (AUC) obtained by comparing subjects who improved by one or more levels on the modified Rankin scale vs. those who exhibit no change on the modified Rankin scale. Larger AUC means higher screening accuracy. In general, an AUC of 0.5 suggests no discrimination, 0.7 to 0.8 is considered acceptable, 0.8 to 0.9 is considered excellent, and more than 0.9 is considered outstanding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18-80 years

• diagnosis of cerebral infraction or intracerebral hemorrhage

• stable vital signs

Exclusion Criteria:

• brain tumor, Parkinson's disease or active epilepsy within three months

• impaired cognitive functions

• participation in any other clinical study

Related Conditions & MeSH terms

• Disability Physical
• Stroke

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Gunagdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The internal responsiveness of Longshi Scale at 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.	Baseline, 20 days after admission(discharge)
Primary	The internal responsiveness of Barthel Index at 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.	Baseline, 20 days after admission(discharge)
Primary	The internal responsiveness of Longshi Scale at 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.	Baseline, 3 months after discharge
Primary	The internal responsiveness of Barthel Index at 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.	Baseline, 3 months after discharge
Secondary	Pearson correlation coefficient (r) between Longshi Scale and Barthel Index at discharge	The external responsiveness is described by Pearson correlation coefficient (r).	Baseline, 20 days after admission(discharge)
Secondary	Pearson correlation coefficient (r) between Longshi Scale and Barthel Index at 3 months after discharge	The external responsiveness is described by Pearson correlation coefficient (r).	Baseline, 3 months after discharge
Secondary	Area under receiver operating characteristic curve of Longshi Scale at discharge	The external responsiveness is described by area under receiver operating characteristic curve (AUC).	Baseline, 20 days after admission(discharge)
Secondary	Area under receiver operating characteristic curve of Longshi Scale at 3 months after discharge	The external responsiveness is described by area under receiver operating characteristic curve (AUC).	Baseline, 3 months after discharge
Secondary	Area under receiver operating characteristic curve of Barthel Index at discharge	The external responsiveness is described by area under receiver operating characteristic curve (AUC).	Baseline, 20 days after admission(discharge)
Secondary	Area under receiver operating characteristic curve of Barthel Index at 3 months after discharge	The external responsiveness is described by area under receiver operating characteristic curve (AUC).	Baseline, 3 months after discharge
Secondary	Longshi Scale	A novel pictorial ADL assessment, 3-9 (better)	Baseline, 20 days after admission(discharge) and 3 months after discharge
Secondary	Barthel Index	ADL assessment, 0-100 (better)	Baseline, 20 days after admission(discharge) and 3 months after discharge