Development and Application of Intelligent Assessment System of Longshi Scale

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Disability Physical

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Shenzhen Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

1. Inclusion Criteria:

   1. Stroke survivors

      • age≥18 years
      • diagnosis of cerebral infraction or intracerebral hemorrhage
      • stable vital signs
      • willingness to participate in the study with informed consent

   2. 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

   3. Non-professional evaluators：

      • the family or caregiver of stroke survivors
      • ability to read and communicate
      • willingness to participate in the study with informed consent

2. Exclusion Criteria:

   1. Stroke survivors:

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

   2. Professional evaluators:

      • refusal to participate in the study

   3. Non-professional evaluators:

      • care for patients with serious mental health problems
      • refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of evaluators' preference	After completing all the evaluations, each evaluator was asked to reveal their preferred version (paper version, electronic version or no preference). Chi-square test was used to compare the proportion of evaluators' preference.	Within 48 hours
Time required	Time required in each section of electronic version and paper version of Longshi Scale.	Within 48 hours
Test-retest reliability of electronic version Longshi Scale	Weighted kappa was used to determine test-retest reliability of electronic version 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 after first evaluation

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Activities of Daily Living; Electronic Version
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 20210812003-FS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No