Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis

NCT ID: NCT06041542

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-12-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Case group

Collect video of hand grasping from patients with cervical spondylotic myelopathy through intelligent video analysis system.

10-second hand grip and release test

Intervention Type: DIAGNOSTIC_TEST

To grip and release hand in ten seconds

Control group

Collect video of hand grasping from normal people through intelligent video analysis system.

10-second hand grip and release test

Intervention Type: DIAGNOSTIC_TEST

To grip and release hand in ten seconds

Differentiate group

Collect video of hand grasping from Stroke and Parkinson's disease through intelligent video analysis system.

10-second hand grip and release test

Intervention Type: DIAGNOSTIC_TEST

To grip and release hand in ten seconds

Interventions

10-second hand grip and release test

To grip and release hand in ten seconds

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age between 18-80 years old;

2. 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);

3. 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).

Exclusion Criteria

1. Subjects with cervical spondylosis who have been examined but still cannot be definitively diagnosed or ruled out;

2. Subjects with definite presence of hand trauma;

3. People who do not have access to CT or MR;

4. Subjects who did not comply with the examination, were unable to perform neurological assessment, or were unable to fill out questionnaires.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

YunBing Chang

Head of spine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunbing Chang, M.D.

Role: STUDY_CHAIR

Guangdong Provincial People's Hospital

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GDREC2020291H

Identifier Type: -

Identifier Source: org_study_id