- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05906719
Machine Vision Based MDS-UPDRS III Machine Rating
August 20, 2026 updated by: Ruijin Hospital
Machine Vision Based Machine Rating of MDS-UPDRS III
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1679
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100050
- Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University
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Beijing, Beijing Municipality, China, 100730
- Beijing Hospital, Neurology Department
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Fujian
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Fuzhou, Fujian, China, 350001
- Department of Neurology, Fujian Medical University Union Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
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Hubei
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Wuhan, Hubei, China, 430022
- Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Suzhou, Jiangsu, China, 215004
- Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200025
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Sichuan
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Chengdu, Sichuan, China, 610044
- Department of Neurology, West China Hospital, Sichuan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
In this study, participants are mainly recruited from the Department of Neurology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, as well as from movement disorder clinics at 7 other centers.
Participants are enrolled through outpatient assessment and screening.
Two specialists in movement disorders independently diagnosed participants as having "Parkinsonism".
In cases where there is a diagnostic disagreement, the Movement Disorder Specialist Group at the Department of Neurology, Ruijin Hospital collectively discusses and makes the decision.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Item-level: MAE
Time Frame: 1 day
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At the item level, mean absolute error (MAE) between paired AI scores and consensus reference scores, calculated as the average absolute difference across items.
Lower values indicate closer agreement.
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1 day
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Item-level: P(|Δ|≥2)
Time Frame: 1 day
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At the item level, the proportion of paired AI and consensus reference scores with an absolute difference of 2 or more points.
Lower values indicate fewer large item-level scoring disagreements.
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1 day
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Score-level: ICC
Time Frame: 1 day
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Intraclass correlation coefficient (ICC) between AI-derived scores and consensus reference scores, calculated separately for each of the four subdomain scores and the total score.
Higher ICC values indicate greater agreement.
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1 day
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Score-level: SEM
Time Frame: 1 day
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Standard error of measurement (SEM) for AI-derived scores relative to consensus reference scores, calculated separately for each of the four subdomain scores and the total score.
SEM quantifies measurement error in the units of the corresponding score, with lower values indicating greater measurement precision.
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1 day
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Score-level: SDC
Time Frame: 1 day
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Smallest detectable change (SDC), derived from the measurement error and calculated separately for each of the four subdomain scores and the total score.
SDC represents the minimum score change required to exceed expected measurement error.
Lower values indicate greater measurement precision.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Item-level: Within-one agreement (ACC1; P(|Δ| ≤ 1))
Time Frame: 1 day
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At the item level, ACC1 is defined as the proportion of paired AI and consensus reference scores with an absolute difference of no more than 1 point, i.e., P(|Δ| ≤ 1).
Higher values indicate closer item-level agreement.
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1 day
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Item-level: Exact-error proportions [P(|Δ| = k)]
Time Frame: 1 day
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At the item level, exact-error proportions, P(|Δ| = k), represent the proportions of paired AI and consensus reference scores with each exact absolute error magnitude k.
In particular, P(|Δ| = 0) corresponds to exact-match accuracy (ACC), defined as the proportion of items for which the AI score exactly matches the consensus reference score.
The remaining values of k characterize the distribution of item-level scoring errors.
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1 day
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Item-level: Per-class exact recall
Time Frame: 1 day
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At the item level, for each consensus reference score class, the proportion of items for which the AI score exactly matches the consensus reference score among all items belonging to that reference class.
Higher values indicate better class-specific exact agreement.
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1 day
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Item-level: Confusion matrix
Time Frame: 1 day
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At the item level, a cross-tabulation of AI scores against consensus reference scores, showing the number of paired ratings for each combination of reference and AI score categories.
Rows represent consensus reference scores and columns represent AI scores.
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1 day
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Item-level: Row-normalised confusion matrix
Time Frame: 1 day
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At the item level, the confusion matrix normalised within each consensus reference score row so that each row sums to 1, showing the distribution of AI scores conditional on each reference score class.
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1 day
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Score-level: Limits of agreement
Time Frame: 1 day
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Bland-Altman limits of agreement between AI-derived scores and consensus reference scores, calculated separately for each of the four subdomain scores and the total score.
The limits characterize the range within which most paired differences between AI and reference scores are expected to fall.
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1 day
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Score-level: MAE
Time Frame: 1 day
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Mean absolute error (MAE) between AI-derived scores and consensus reference scores, calculated separately for each of the four subdomain scores and the total score as the average absolute difference between paired scores.
Lower values indicate smaller scoring errors.
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1 day
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Score-level: RMSE
Time Frame: 1 day
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Root mean square error (RMSE) between AI-derived scores and consensus reference scores, calculated separately for each of the four subdomain scores and the total score.
RMSE gives greater weight to larger scoring errors, with lower values indicating closer agreement.
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1 day
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Score-level: Spearman correlation
Time Frame: 1 day
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Spearman rank correlation between AI-derived scores and consensus reference scores, calculated separately for each of the four subdomain scores and the total score.
Higher values indicate a stronger monotonic association between AI-derived and reference scores.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
June 7, 2023
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 20, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- u3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.