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Completed

NCT Number: NCT05780866

Remote Monitoring in Parkinson's Disease

The goal of this observational study is to learn about the usefulness of physical activity measures and tremor detection using wearable devices and smartphone video to detect and evaluate disease burden in people with Parkinson's disease.

Participants will wear an activity tracker at home and complete a short research visit where they will make a video using a smartphone of themselves performing a fine motor task. They will wear the activity tracker for two weeks at home.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

For all groups (there is no control group):

At enrollment, the participants will complete a baseline survey that records participant sex, years since the diagnosis of Parkinson's disease, current use of levodopa medication, and whether levodopa was taken today.

Next, a research nurse from neurology will complete the Unified Parkinson's Disease Rating Scale (UPDRS) assessment. As part of this assessment, the researchers will make a video recording of Part 3 (the motor assessment) as a gold standard for comparison with the participant-recorded videos.

Next, the participant will complete the PDQ-39 (Parkinson's disease questionnaire), a 39 item questionnaire about the quality of life.

After completing the PDQ-39, the researchers will provide the participant with a camera, small tripod, and a set of written directions about how to perform the UPDRS motor assessment. The goal with this task is to simulate a home recording session to uncover any issues and create preliminary data for validation of the home recording compared to the gold standard collected by the study team. The recordings will then be converted to x, y, z landmarks using MediaPipe, running on UIowa hardware.

After completing the video, the participant will complete a short survey about ease of making the video recording.

After completing the baseline assessments, the research team will provide the participant with a Fitbit Inspire 3 activity tracker watch, configure the tracker to sync with their phone, and provide an overview of use.

The participant will wear the activity tracker for 24 hours a day for the next 14 days except for if the device needs charging and when bathing.

At 14 days, the research team will send participants a link to complete a web-based exit survey about their experience with the activity tracker during the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PD
  • Current patient at UIHC Movement Disorders clinic
  • Owns a smartphone that is compatible with a activity tracker.

Exclusion criteria

  • Non-English speaking
  • Bedridden or uses a wheelchair the majority of the time
  • Prisoner status
  • Inability to provide own informed consent

Treatment and study plan

Video and Activity Tracker

Other

At enrollment, the participants will complete a baseline survey, PDQ-39 (Parkinson's disease questionnaire), and the Unified Parkinson's Disease Rating Scale (UPDRS) assessment. The researchers will provide the participant with a camera, small tripod, and a set of written directions about how to record the UPDRS motor self-assessment video.

After completing the baseline assessments, the research team will provide the participant with a Fitbit Inspire 3 activity tracker watch. The participant will wear the activity tracker for 24 hours a day for the next 14 days except for if the device needs charging and when bathing.

At 14 days, the research team will send participants a link to complete a web-based exit survey about their experience with the activity tracker during the study.

Primary outcomes

  1. Activity tracker wear rate

    Time frame: 14 Days

    Percent of time activity tracker records a heart rate

  2. Accuracy of computer vision assessment of motor function

    Time frame: Baseline

    Average difference in UPDRS score between human and computer assessments

  3. Do step counts predict quality-of-life

    Time frame: 14 Days

    Regression of PDQ-39 on demographics and activity tracker step counts

Sponsors and collaborators

Lead sponsor

Jacob E. Simmering

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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