NCT05150743

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 6, 2023

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

October 9, 2021

Last Update Submit

February 3, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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

  • 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 Outcomes (8)

  • 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)

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Gunagdong, 518035, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2021

First Posted

December 9, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 6, 2023

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Contact the principal investigator for data if necessary

Locations