NCT04074772

Brief Summary

The objective of this study is the development of a system that will allow for the precise measurement of movement kinematics in a clinical exam setting using natural video from three cameras and machine learning to track points of interest. The investigators aim to implement such system in an unobtrusive and simply-incorporated way into the physical exam to provide exact, objective measures to detect patient movement abnormalities in ways not feasible with current tracking technologies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

August 27, 2019

Last Update Submit

January 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful Tracking Achieved in Clinic

    If the neural network can generalize to different patients and contexts with accurate tracking, such that it can track all 12 points of interest with \>99% accuracy in \>95% of frames of novel video data, the investigators will consider this outcome a success.

    On the day of physical exam

Secondary Outcomes (1)

  • Identification of Diseases by Movement Tracking

    On the day of physical exam

Study Arms (3)

Healthy Controls

This group will consist of healthy controls between the ages of 18 and 70-years-old. Following consent, they will complete a simplified motor physical exam while being filmed from three angles. This video data will be used to train a neural network to identify points of interest in a generalized patient population.

Movement Disorder Patients

This group will consist of movement disorder clinic patients between the ages of 18 and 70-years-old with a diagnosed or putative movement disorder. Following consent, they will complete a simplified motor physical exam while being filmed from three angles. This video data will be analyzed with the neural network trained on the healthy controls.

Age-Matched Controls

This group will consist of relatives of movement disorder clinic patients that are visiting with them to serve as age-matched controls (within 10 years of patient's age). Following consent, they will complete a simplified motor physical exam while being filmed from three angles. This video data will be analyzed with the neural network trained on the healthy controls.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Healthy controls: health volunteers recruited within the Anschutz Medical Campus * Age-Matched controls: spouses and relatives of patients visiting the movement disorders clinic at the University of Colorado Hospital within 10 years of patient's age. * Movement Disorder Patients: patients visiting the movement disorders clinic at the University of Colorado Hospital

You may qualify if:

  • Healthy controls: within age range
  • Age-Matched controls: within age range
  • Movement Disorder Patients: have diagnosed or putative movement disorder

You may not qualify if:

  • Healthy controls: have diagnosed or putative movement disorder; outside of age range
  • Age-Matched controls: have diagnosed or putative movement disorder; outside of age range
  • Movement Disorder Patients: outside of age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Mathis A, Mamidanna P, Cury KM, Abe T, Murthy VN, Mathis MW, Bethge M. DeepLabCut: markerless pose estimation of user-defined body parts with deep learning. Nat Neurosci. 2018 Sep;21(9):1281-1289. doi: 10.1038/s41593-018-0209-y. Epub 2018 Aug 20.

    PMID: 30127430BACKGROUND

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

August 27, 2019

First Posted

August 30, 2019

Study Start

December 7, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Will not share IPD

Locations