Development and Application of Intelligent Assessment System of Longshi Scale

Stroke Clinical Trial

Official title:

Development and Application of Intelligent Assessment System of Longshi Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214638
• Other study ID #: 20210812003-FS01
• Status: Completed
• Start date: September 10, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical
• Stroke

Locations

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

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	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 (? = 0.00-0.20), fair (?= 0.21-0.40), moderate (? = 0.41-0.60), good (? = 0.61-0.80),and very good (? = 0.81-1.00).	Within 48 hours
Secondary	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
Secondary	Time required	Time required in each section of electronic version and paper version of Longshi Scale.	Within 48 hours
Secondary	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 (? = 0.00-0.20), fair (?= 0.21-0.40), moderate (? = 0.41-0.60), good (? = 0.61-0.80),and very good (? = 0.81-1.00).	Within 48 hours after first evaluation