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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05906719
Other study ID # u3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date April 1, 2024

Study information

Verified date March 2023
Source Ruijin Hospital
Contact Lun Liu, MD,PhD
Phone 021-86-64370045
Email jly0520@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Movement Disorders Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III (MDS-UPDRS III) is the primary assessment method for motor symptoms in Parkinson's disease patients. Currently, movement disorder specialists conduct semi-quantitative scoring, which entails limitations such as subjectivity, weak sensitivity, and a limited number of professional physicians. This study, based on machine vision, establishes gold standard labels according to expert scoring. By using machine learning, we develop a machine rating model and compare the model's performance with gold standard rating and general clinical rating to investigate the accuracy of machine vision-based MDS-UPDRS III machine rating.


Recruitment information / eligibility

Status Recruiting
Enrollment 871
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Meeting the diagnostic criteria for Parkinsonism established by the International Movement Disorder Society: having bradykinesia, and meeting at least one of the two criteria for resting tremor or muscle rigidity - 20 to 80 years old - Good compliance, voluntarily joining the study, and able to sign an informed consent form or have it signed by a legal representative Exclusion Criteria: - Significant cognitive impairment (MMSE = 23) - Unable to sign written informed consent or unable to complete the trial due to other reasons - Other situations in which the researcher deems the participant unsuitable for this study - Participation in other clinical trials

Study Design


Related Conditions & MeSH terms


Intervention

Other:
video recording
Patients' performance of MDS-UPDRS III will be recorded.

Locations

Country Name City State
China Beijing Hospital, Neurology Department Beijing Beijing
China Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University Beijing Beijing
China Department of Neurology, West China Hospital, Sichuan University Chengdu Sichuan
China Department of Neurology, Fujian Medical University Union Hospital Fuzhou Fujian
China Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences Guangzhou Guangdong
China Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
China Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (8)

Lead Sponsor Collaborator
Ruijin Hospital Beijing Hospital, Beijing Tiantan Hospital, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Second Affiliated Hospital of Soochow University, West China Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ACC0 of machine rating vs gold standard rating The accuracy rate when machine rating equals gold standard rating. 1 day
Primary ACC1 of machine rating vs gold standard rating The accuracy rate when machine rating equals the range of gold standard rating plus or minus one. 1 day
Primary Weighted kappa of machine rating vs gold standard rating The weighted kappa when machine rating equals gold standard rating. 1 day
Primary Lin's CCC of machine rating vs gold standard rating The Lin's Concordance Correlation Coefficient when machine rating equals gold standard rating. 1 day
Secondary Accuracy rate of machine rating vs general clinical rating Comparing the absolute residuals between machine rating and the gold standard rating with the absolute residuals between general clinical raitng and the gold standard rating. 1 day
Secondary Accuracy rate of machine facilitated rating vs general clinical rating Comparing the absolute residuals between machine facilitated rating and the gold standard rating with the absolute residuals between general clinical raitng and the gold standard rating. 1 day
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