10-second G&R TestNCT06041542
Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis
An observational study of 10-second G&R Test, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The purpose of this study: 1. Build an artificial intelligence screening tool for cervical spondylosis based on hand function analysis; 2. Verify the accuracy of cervical spondylosis screening tools. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- 10-second G&R Test
- What is being tested?
- 10-second hand grip and release test
- How many people
- 1,380 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 asymptomatic population in community; 200 cases of cervical spondylosis; Arthritis, Parkinson's disease, cerebral apoplexy 60 patients each.
Who may be able to join
- Age between 18-80 years old;
- Patients who have received cervical CT or MR examination within the last month and have been clearly diagnosed or excluded from cervical spondylosis (i.e., those who have been clearly diagnosed before participating in the study);
- People who are willing to participate in the study with CT/MR examination (i.e., those who have not been diagnosed before joining the study).
Who cannot join
- Subjects with cervical spondylosis who have been examined but still cannot be definitively diagnosed or ruled out;
- Subjects with definite presence of hand trauma;
- People who do not have access to CT or MR;
- Subjects who did not comply with the examination, were unable to perform neurological assessment, or were unable to fill out questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study:
- Build an artificial intelligence screening tool for cervical spondylosis based on hand function analysis;
- Verify the accuracy of cervical spondylosis screening tools.
Read the detailed description
Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly people. According to clinical research, the surgeon can makes a preliminary assessment of the severity of CSM based on a 10-second grip and release (G\&R) test. The statistics of G\&R test mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast, the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We construct and verify the intelligent video analysis system for Grip-\&-release. The system has a high accuracy and inference speed that ensure the proposed model can be used as a screening examination tool for CSM and a medical assistance tool to help decision making during CSM treatment planning.
- Conditions
- 10-second G&R Test
- Being tested
- 10-second hand grip and release test
- Keywords
- 10-second G&R test, cervical spondylotic myelopathy, hand motion analysis, video analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-second hand grip and release testDiagnostic test
To grip and release hand in ten seconds
| Study group | Role | What they receive |
|---|---|---|
| Case group | Collect video of hand grasping from patients with cervical spondylotic myelopathy through intelligent video analysis system. Receives: Diagnostic Test: 10-second hand grip and release test | |
| Control group | Collect video of hand grasping from normal people through intelligent video analysis system. Receives: Diagnostic Test: 10-second hand grip and release test | |
| Differentiate group | Collect video of hand grasping from Stroke and Parkinson's disease through intelligent video analysis system. Receives: Diagnostic Test: 10-second hand grip and release test |
What is being measured
The primary outcome is the main question the study is designed to answer.
mJOA score
Correlate 10-second hand grip and release test with mJOA score
Measured: 2022-10-01-2022-12-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Dec 2020
- Primary completion31 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 10-second G&R TestStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YunBing Chang, Guangdong Provincial People's Hospital
- Investigators
- Yunbing Chang, M.D., Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041542
- Sponsor's protocol ID
- GDREC2020291H
- Status last verified
- Sep 2023
- First submitted
- 3 Jul 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT06041542
- Acronym / sponsor ID
- GDREC2020291H
- Conditions
- 10-second G&R Test
- Keywords
- 10-second G&R test, cervical spondylotic myelopathy, hand motion analysis, video analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,380 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Sep 2023 (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:
- Build an artificial intelligence screening tool for cervical spondylosis based on hand function analysis;
- Verify the accuracy of cervical spondylosis screening tools.
Detailed description
Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly people. According to clinical research, the surgeon can makes a preliminary assessment of the severity of CSM based on a 10-second grip and release (G\&R) test. The statistics of G\&R test mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast, the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We construct and verify the intelligent video analysis system for Grip-\&-release. The system has a high accuracy and inference speed that ensure the proposed model can be used as a screening examination tool for CSM and a medical assistance tool to help decision making during CSM treatment planning.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: 10-second hand grip and release testCollect video of hand grasping from patients with cervical spondylotic myelopathy through intelligent video analysis system. |
| Control group | – | Diagnostic Test: 10-second hand grip and release testCollect video of hand grasping from normal people through intelligent video analysis system. |
| Differentiate group | – | Diagnostic Test: 10-second hand grip and release testCollect video of hand grasping from Stroke and Parkinson's disease through intelligent video analysis system. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 asymptomatic population in community; 200 cases of cervical spondylosis; Arthritis, Parkinson's disease, cerebral apoplexy 60 patients each.
Key inclusion criteria (3 listed)
- Age between 18-80 years old;
- Patients who have received cervical CT or MR examination within the last month and have been clearly diagnosed or excluded from cervical spondylosis (i.e., those who have been clearly diagnosed before participating in the study);
- People who are willing to participate in the study with CT/MR examination (i.e., those who have not been diagnosed before joining the study).
Key exclusion criteria (4 listed)
- Subjects with cervical spondylosis who have been examined but still cannot be definitively diagnosed or ruled out;
- Subjects with definite presence of hand trauma;
- People who do not have access to CT or MR;
- Subjects who did not comply with the examination, were unable to perform neurological assessment, or were unable to fill out questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-second hand grip and release testTo grip and release hand in ten seconds | Diagnostic test | Case group, Control group, Differentiate group |
Primary outcome
mJOA score
Time frame: 2022-10-01-2022-12-30
Correlate 10-second hand grip and release test with mJOA score
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 18 Sep 2023.
- Individual participant dataSharing planned: Undecided
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.
Yunbing Chang, M.D. study chair
Guangdong Provincial People's Hospital
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 10-second G&R Test, run by Guangdong Provincial 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 Sep 2023. 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?
mJOA score (time frame: 2022-10-01-2022-12-30). 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 18 Sep 2023.