NCT05906719

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
871

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 18, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

June 7, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • ACC0 of machine rating vs gold standard rating

    The accuracy rate when machine rating equals gold standard rating.

    1 day

  • 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

  • Weighted kappa of machine rating vs gold standard rating

    The weighted kappa when machine rating equals gold standard rating.

    1 day

  • 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 Outcomes (2)

  • Accuracy rate of machine rating vs general clinical rating

    1 day

  • Accuracy rate of machine facilitated rating vs general clinical rating

    1 day

Interventions

Patients' performance of MDS-UPDRS III will be recorded.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

NOT YET RECRUITING

Beijing Hospital, Neurology Department

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Department of Neurology, Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

NOT YET RECRUITING

Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Department of Neurology, West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinsonian Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

June 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations