StrokeNCT05214638
Development and Application of Intelligent Assessment System of Longshi Scale
An observational study of Stroke and Disability Physical, run by Shenzhen Second People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Disability Physical
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2021to 31 Dec 2021
- 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
- Inclusion Criteria:
- Stroke survivors
- age≥18 years
- diagnosis of cerebral infraction or intracerebral hemorrhage
- stable vital signs
- willingness to participate in the study with informed consent
- 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
- Non-professional evaluators：
- the family or caregiver of stroke survivors
- ability to read and communicate
- willingness to participate in the study with informed consent
- Exclusion Criteria:
- Stroke survivors:
- brain tumor, Parkinson's disease or active epilepsy within past three months
- impaired cognitive functions
- participation in any other clinical study
- Professional evaluators:
- refusal to participate in the study
- Non-professional evaluators:
- care for patients with serious mental health problems
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, Disability Physical
- Keywords
- Stroke, Activities of Daily Living, Electronic Version
- 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 paper version of Longshi Scale first and then with electronic version | Not described | |
| Assessed with the electronic version of Longshi Scale first and then with the paper version | 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 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).
Measured: Within 48 hours
Secondary outcomes (3)
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.
Measured: Within 48 hours
Time required
Time required in each section of electronic version and paper version of Longshi Scale.
Measured: 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).
Measured: Within 48 hours after first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start10 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 115 participants (actual)
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
- NCT05214638
- Sponsor's protocol ID
- 20210812003-FS01
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xue K, Li W, Liu F, Liu X, Wong J, Zhou M, Cai C, Long J, Li J, Zhang Z, Hou W, Nie G, Wang Y. Evaluation of activities of daily living using an electronic version of the Longshi Scale in patients with stroke: reliability, consistency, and preference. BMC Med Inform Decis Mak. 2024 May 15;24(1):125. doi: 10.1186/s12911-024-02508-0.
PubMed 38750562
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Intelligent Assessment System of Longshi Scale
- ClinicalTrials.gov ID
- NCT05214638
- Acronym / sponsor ID
- 20210812003-FS01
- Conditions
- Stroke, Disability Physical
- Keywords
- Stroke, Activities of Daily Living, Electronic Version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Jan 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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
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
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 electronic version and the paper version of Longshi Scale
Time frame: Within 48 hours
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).
3 secondary outcomes
Proportion of evaluators' preference
Time frame: Within 48 hours
Time required
Time frame: Within 48 hours
Test-retest reliability of electronic version Longshi Scale
Time frame: Within 48 hours after first evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 38750562Xue K, Li W, Liu F, Liu X, Wong J, Zhou M, Cai C, Long J, Li J, Zhang Z, Hou W, Nie G, Wang Y. Evaluation of activities of daily living using an electronic version of the Longshi Scale in patients with stroke: reliability, consistency, and preference. BMC Med Inform Decis Mak. 2024 May 15;24(1):125. doi: 10.1186/s12911-024-02508-0.
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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 Disability Physical, 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?
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: finished, as of the sponsor's last update on 31 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 electronic version and the paper version of Longshi Scale (time frame: Within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214638, which also lists 1 linked publication.
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 31 Jan 2022.