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

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.

Study Overview

• Status: Completed
• Conditions: 10-second G&R Test
• Intervention / Treatment: Diagnostic test: 10-second hand grip and release test

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 Type: Observational
• Enrollment (Actual): 1380

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1000 asymptomatic population in community; 200 cases of cervical spondylosis; Arthritis, Parkinson's disease, cerebral apoplexy 60 patients each.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Collect video of hand grasping from patients with cervical spondylotic myelopathy through intelligent video analysis system.	Diagnostic test: 10-second hand grip and release test; To grip and release hand in ten seconds
Control group; Collect video of hand grasping from normal people through intelligent video analysis system.	Diagnostic test: 10-second hand grip and release 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.	Diagnostic test: 10-second hand grip and release test; To grip and release hand in ten seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mJOA score	Correlate 10-second hand grip and release test with mJOA score	2022-10-01-2022-12-30

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Chair: Yunbing Chang, M.D., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cervical spondylotic myelopathy; 10-second G&R test; hand motion analysis; video analysis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: GDREC2020291H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No