StrokeNCT05395637
Reliability of Longshi Scale With Remote Assessment
An observational study of Stroke and Telemedicine, run by Shenzhen Second People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Telemedicine
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
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- b.Evaluators
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- registered rehabilitation practitioner;
- experience in rehabilitation scientific research or education related work for more than two years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke, Telemedicine
- Keywords
- Stroke, Tele-rehabilitation, Activities of Daily Living
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Assessed with the remote assessment of Longshi Scale first and then with bedside assessment | Not described | |
| Assessed with the bedside assessment of Longshi Scale first and then with remote assessment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours
Secondary outcomes (3)
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).
Measured: Within 24 hours after first evaluation
Satisfaction survey of remote assessment
The satisfaction survey data were summarized as mean±standard deviation, and also summarized as the percentage of satisfaction categories.
Measured: Within 24 hours after the remote assessment
Assessment duration
The assessment duration was analyzed by independent t-test.
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start20 May 2022 (estimated)
- Primary completion25 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395637
- Sponsor's protocol ID
- 20220224002
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Longshi Scale With Remote Assessment of Smartphone Video Calls for Stroke Patients'Activities of Daily Living
- ClinicalTrials.gov ID
- NCT05395637
- Acronym / sponsor ID
- 20220224002
- Conditions
- Stroke, Telemedicine
- Keywords
- Stroke, Tele-rehabilitation, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 25 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- a.Stroke survivors
- b.Evaluators
- <!-- -->
Key exclusion criteria (6 listed)
- a.Stroke survivors
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
The test-retest reliability of the remote video assessment
Time frame: Within 24 hours after first evaluation
Satisfaction survey of remote assessment
Time frame: Within 24 hours after the remote assessment
Assessment duration
Time frame: Within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Telemedicine, run by Shenzhen Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of the disability degree evaluated using the remote assessment and the bedside assessment of Longshi Scale. (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.