Disability PhysicalNCT05150743

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

An observational study of Disability Physical and Stroke, run by Shenzhen Second People's Hospital at 1 site in China.

Completed

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

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Disability Physical, Stroke
How many people: 180 participants
Where: 1 siteChina
Study dates: 1 May 2021to 31 Dec 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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Stroke survivors from the Department of Rehabilitation Medicine at Shenzhen Second People's Hospital are invited to participate in this study according to the inclusion and exclusion criteria.

Who may be able to join

age 18-80 years
diagnosis of cerebral infraction or intracerebral hemorrhage
stable vital signs

Who cannot join

brain tumor, Parkinson's disease or active epilepsy within three months
impaired cognitive functions
participation in any other clinical study

Trial locations and contacts

1 site in 1 country.

China1 site

Shenzhen Second People's Hospital
Shenzhen, Gunagdong, 518035

Other trials in China

About this study

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

Read the detailed 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:

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.
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.
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.

Conditions: Disability Physical, Stroke
Medical subject headings: Stroke

What is being measured

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

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.
Measured: Baseline, 20 days after admission(discharge)
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.
Measured: Baseline, 20 days after admission(discharge)
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.
Measured: Baseline, 3 months after discharge
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.
Measured: Baseline, 3 months after discharge

Secondary outcomes (8)

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

Timeline

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

1 May 202131 Dec 2021

First posted9 Dec 2021
Study start1 May 2021
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Disability PhysicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Cohort
Time perspective: Prospective
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05150743
Sponsor's protocol ID: 20210219006-FS01
Status last verified: Apr 2021
First submitted: 9 Oct 2021
Last updated: 6 Feb 2023
Results posted: No
Individual data sharing: No: Contact the principal investigator for data if necessary

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Disability Physical trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Longshi Scale and Barthel Index to Evaluate the Ability of Daily Living Activities in Stroke Survivors: a Comparative Study
ClinicalTrials.gov ID: NCT05150743
Acronym / sponsor ID: 20210219006-FS01
Conditions: Disability Physical, Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Shenzhen Second People's HospitalUniversity, hospital or other
Study start: 1 May 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 9 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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:

Statistical analysis:

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.
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.
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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Stroke survivors from the Department of Rehabilitation Medicine at Shenzhen Second People's Hospital are invited to participate in this study according to the inclusion and exclusion criteria.

Key inclusion criteria (3 listed)

age 18-80 years
diagnosis of cerebral infraction or intracerebral hemorrhage
stable vital signs

Key exclusion criteria (3 listed)

brain tumor, Parkinson's disease or active epilepsy within three months
impaired cognitive functions
participation in any other clinical study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The internal responsiveness of Longshi Scale at discharge
Time frame: 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.
The internal responsiveness of Barthel Index at discharge
Time frame: 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
Time frame: 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
Time frame: 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.

8 secondary outcomes

Pearson correlation coefficient (r) between Longshi Scale and Barthel Index at discharge
Time frame: Baseline, 20 days after admission(discharge)
Pearson correlation coefficient (r) between Longshi Scale and Barthel Index at 3 months after discharge
Time frame: Baseline, 3 months after discharge
Area under receiver operating characteristic curve of Longshi Scale at discharge
Time frame: Baseline, 20 days after admission(discharge)
Area under receiver operating characteristic curve of Longshi Scale at 3 months after discharge
Time frame: Baseline, 3 months after discharge
Area under receiver operating characteristic curve of Barthel Index at discharge
Time frame: Baseline, 20 days after admission(discharge)
Area under receiver operating characteristic curve of Barthel Index at 3 months after discharge
Time frame: Baseline, 3 months after discharge
Longshi Scale
Time frame: Baseline, 20 days after admission(discharge) and 3 months after discharge
Barthel Index
Time frame: Baseline, 20 days after admission(discharge) and 3 months after discharge

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
Individual participant dataSharing planned: No. Contact the principal investigator for data if necessary

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Disability Physical and Stroke, run by Shenzhen Second People's Hospital at 1 site in China.

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 3 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 6 Feb 2023. 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 China. 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?

The internal responsiveness of Longshi Scale at discharge (time frame: Baseline, 20 days after admission(discharge)). 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 NCT05150743.

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 6 Feb 2023.