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CompletedNCT04074772Updated Jan 11, 2022

Leveraging Machine Learning to Effortlessly Track Patient Movement in the Clinic.

An observational study in Movement Disorders, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
25
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the detailed description

Aim 1: Develop 3D tracking capable of capturing behavior of healthy controls during physical exams. In aim 1, the investigators will recruit healthy volunteers to perform a simplified physical exam in a replica exam room while being recorded with three synchronized FLIR cameras. The simplified exam will consist of four tasks: assessment of tremor, finger chase, finger-to-nose movements, and finger tapping. Study staff will then use DeepLabCut (DLC) software -technology that trains artificial neural networks to identify user defined features in an image - to recognize body parts of interest in physical exam videos. Once the network is fully trained the investigators will test its ability to generalize on different patients and different contexts. Additional analysis of volunteers' movement during the physical exam will be performed to assess for characteristics such as tremor, speed, and tortuosity of movement.

Aim 2: Apply 3D tracking to the clinic to track physical exam behaviors in motor disorder patients. In aim 2, the investigators will apply the trained network to the clinic to examine the physical exam characteristics of movement disorder patients. Aim 2a will test the DLC network's ability to capture movement disorder abnormalities during the physical exam in patients and healthy age-matched controls. DLC scores of each test variable will be compared to the physician's score of movement according to a standardized scale. The investigators expect to find that the DLC tracking method is able to objectively score movement disorders in ways that mirror and surpass the ability of the physician. In Aim 2b, the investigators will explore the population of recruited patients to see whether it is possible to pull out characteristic movements that correspond to certain disease states. In this exploratory aim, the investigators expect to be able to separate different disease groups (e.g.: Parkinsonian and ataxic patients) from each other based simply on the tracked movement characteristics.

Research Methods:

In Aim 1, a movement arena will be built on the University of Colorado Denver Graduate School campus using three FLIR cameras with a custom built synchronization and initiation system. The investigators will recruit up to 30 healthy 18-70-year-old controls from the University of Colorado Denver Graduate School to perform the simplified physical exam (assessment of tremor, finger chase, finger-to-nose movements, and finger tapping) while video is captured from three angles at 100 Hz. The investigators expect this testing to take no more than 5 minutes per subject. This video will be used to train the DLC artificial neural network to recognize limb features. The investigators will measure the ability of our trained DLC network to characterize twelve points of interest on each limb during a physical exam: the tips of the four fingers and the thumb, all four metacarpophalangeal joints, the center of the hand, the elbow, and the shoulder. A successful outcome will be a network that maintains the ability to recognize features of interest at high confidence between different individuals and different room contexts.

In Aim 2a, a tracking arena will be set up in a University of Colorado Movement Disorder Clinic exam room. The investigators will recruit up to 100 patients between 18-70 years old that are visiting for a movement disorder related appointment as well as spouses and relatives of the patients at the appointment for healthy age-matched controls. Patients in the clinic will be asked after their visit if they would like to participate in the study. If they consent, the physician will obtain written consent and fill out a patient form that includes the patient's age, race, sex, and diagnosis (or putative diagnosis). Video recording will be started and the physician will perform the simplified physical exam mentioned above. The physicians will judge the finger chase and finger-to-nose task as is described in the Scale for the Assessment and Rating of Ataxia (SARA, items 5 \& 6) from 0-4. The postural tremor and finger tapping will be judged according to the Unified Parkinson Disease Rating Scale (UPDRS, items 21 \& 23) from 0-4. If the patient is visiting with a person that consents to be an age-matched control (within 10 years of the patient's age) the physical exam will be repeated as above. The investigators expect this testing to take no more than 5 minutes per subject, beginning to end. The investigators will then use the DLC algorithm to score the physical exam in a way analogous to the physician scoring to assess the accuracy of the system.

In Aim 2b, the investigators will explore the patient data from Aim 2a for movement features specific to individual diseases. Data clustering methods (PCA and t-SNE) will be used to separate data into groups using high-dimensional DLC tracking data from each physical exam task. Success will be measured as the ability to separate diseases from one another based solely on the analysis of movement data.

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Conditions studied

  • Movement Disorders

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03

In context

Movement Disorders

320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.

This study's enrollment of 25 is below the median of 80 across 132 observational studies indexed under Movement Disorders.

Browse Movement Disorders studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Other
Time perspective
Other
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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.

    Time frame: On the day of physical exam

Secondary outcomes

  1. Identification of Diseases by Movement Tracking

    If the investigators can separate different movement disorders from one another based on tracking data alone this outcome will be considered a success. Specifically, in LOTO cross validation, individual patient data must be assigned the correct disease state with 95% confidence.

    Time frame: On the day of physical exam

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Study locations

1 site
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
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References and documents

Publications

  • 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. PubMed 30127430 ↗

Individual participant data

Plan to share: No — Will not share IPD

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04074772
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Aug 30, 2019
Start date
Dec 7, 2020
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021
Last update
Jan 11, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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