- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395637
Reliability of Longshi Scale With Remote Assessment
May 26, 2022 updated by: Shenzhen Second People's Hospital
Reliability of Longshi Scale With Remote Assessment of Smartphone Video Calls for Stroke Patients'Activities of Daily Living
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Anticipated)
129
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China
- Shenzhen Second People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 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
Inclusion Criteria:
a.Stroke survivors
- aged 18 and above;
- diagnosed with cerebral infraction or intracerebral hemorrhage;
- stroke onset2 weeks;
- stable vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature);
voluntary or guardian consent to participate in the study.
b.Evaluators
- registered rehabilitation practitioner;
- experience in rehabilitation scientific research or education related work for more than two years
Exclusion Criteria:
a.Stroke survivors
- brain tumor, Parkinson's disease or active epilepsy within past three months;
- a history of mental illness such as mania or delirium;
- participation in any other clinical study. b.Evaluators
- unable to finish the training of Longshi Scale or use smartphones proficiently.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Assessed with the remote assessment of Longshi Scale first and then with bedside assessment
|
Assessed with the bedside assessment of Longshi Scale first and then with remote assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consistency of the disability degree evaluated using the remote assessment and the bedside assessment of Longshi Scale.
Time Frame: Within 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The test-retest reliability of the remote video assessment
Time Frame: Within 24 hours after first evaluation
|
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
|
Satisfaction survey of remote assessment
Time Frame: Within 24 hours after the 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
|
Assessment duration
Time Frame: Within 24 hours
|
The assessment duration was analyzed by independent t-test.
|
Within 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2022
Primary Completion (Anticipated)
May 25, 2022
Study Completion (Anticipated)
May 30, 2022
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
May 27, 2022
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220224002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey