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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05395637
Other study ID # 20220224002
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 20, 2022
Est. completion date May 30, 2022

Study information

Verified date May 2022
Source Shenzhen Second People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore the reliability of remote Longshi Scale assessment with smartphone video calls by comparing the consistency of remote assessment and bedside assessment, as well as the test-retest reliability of the remote assessment. The evaluation duration of these two methods was recorded and the level of satisfaction of patients and evaluators was investigated.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 129
Est. completion date May 30, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - a.Stroke survivors 1. aged 18 and above; 2. diagnosed with cerebral infraction or intracerebral hemorrhage; 3. stroke onset2 weeks; 4. stable vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature); 5. voluntary or guardian consent to participate in the study. b.Evaluators 1. registered rehabilitation practitioner; 2. experience in rehabilitation scientific research or education related work for more than two years Exclusion Criteria: - a.Stroke survivors 1. brain tumor, Parkinson's disease or active epilepsy within past three months; 2. a history of mental illness such as mania or delirium; 3. participation in any other clinical study. b.Evaluators 1. unable to finish the training of Longshi Scale or use smartphones proficiently.

Study Design


Related Conditions & MeSH terms


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 remote assessment and the bedside assessment of Longshi Scale. Weighted kappa(wK) and Bland-Altman were used to determined the consistency between the results of remote assessment method and bedside assessment method. The interpretation of wK scores was in accordance with published standards (values>0.75 indicating excellent agreement beyond chance; 0.4~0.75, moderate agreement beyond chance; <0.4, poor agreement beyond chance). Within 24 hours
Secondary The test-retest reliability of the remote video assessment the result of remote assessment test-retest was analyzed by Weighted kappa(wK) scores.The interpretation of wK scores was in accordance with published standards (values>0.75 indicating excellent agreement beyond chance; 0.4~0.75, moderate agreement beyond chance; <0.4, poor agreement beyond chance). Within 24 hours after first evaluation
Secondary Satisfaction survey of remote assessment The satisfaction survey data were summarized as mean±standard deviation, and also summarized as the percentage of satisfaction categories. Within 24 hours after the remote assessment
Secondary Assessment duration The assessment duration was analyzed by independent t-test. Within 24 hours
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