NCT05214638

Brief Summary

The purpose of this study was to verify convenience and feasibility of the novel intelligent Longshi assessment system to provide an accurate and convenient evaluation tool for stroke survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

September 10, 2021

Completed
4 months 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
7 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 7, 2022

Last Update Submit

January 27, 2022

Conditions

Keywords

StrokeActivities of Daily LivingElectronic Version

Outcome Measures

Primary Outcomes (1)

  • Consistency of the disability degree evaluated using the electronic version and the paper version of Longshi Scale

    Weighted kappa was used to determine the consistency of the disability degree evaluated using the electronic version and the paper version of Longshi Scale. Kappa value ranges from 0 to 1 and the thresholds for kappa reliability are as follows: poor (κ = 0.00-0.20), fair (κ= 0.21-0.40), moderate (κ = 0.41-0.60), good (κ = 0.61-0.80),and very good (κ = 0.81-1.00).

    Within 48 hours

Secondary Outcomes (3)

  • Proportion of evaluators' preference

    Within 48 hours

  • Time required

    Within 48 hours

  • Test-retest reliability of electronic version Longshi Scale

    Within 48 hours after first evaluation

Study Arms (2)

Assessed with the paper version of Longshi Scale first and then with electronic version

Assessed with the electronic version of Longshi Scale first and then with the paper version

Eligibility Criteria

Age18 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:

  • Stroke survivors
  • age≥18 years
  • diagnosis of cerebral infraction or intracerebral hemorrhage
  • stable vital signs
  • willingness to participate in the study with informed consent
  • Professional evaluators:
  • One to ten years of working experience
  • experience in rehabilitation scientific research or education related work for more than two years
  • association with Longshi Scale research
  • Non-professional evaluators:
  • the family or caregiver of stroke survivors
  • ability to read and communicate
  • willingness to participate in the study with informed consent

You may not qualify if:

  • Stroke survivors:
  • brain tumor, Parkinson's disease or active epilepsy within past three months
  • impaired cognitive functions
  • participation in any other clinical study
  • Professional evaluators:
  • refusal to participate in the study
  • Non-professional evaluators:
  • care for patients with serious mental health problems
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

Related Publications (1)

  • Xue K, Li W, Liu F, Liu X, Wong J, Zhou M, Cai C, Long J, Li J, Zhang Z, Hou W, Nie G, Wang Y. Evaluation of activities of daily living using an electronic version of the Longshi Scale in patients with stroke: reliability, consistency, and preference. BMC Med Inform Decis Mak. 2024 May 15;24(1):125. doi: 10.1186/s12911-024-02508-0.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 31, 2022

Study Start

September 10, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations