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Clinical Trials/NCT05780866
NCT05780866
Completed
N/A

Remote Monitoring in Parkinson's Disease

Jacob E. Simmering1 site in 1 country25 target enrollmentAugust 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Jacob E. Simmering
Enrollment
25
Locations
1
Primary Endpoint
Activity tracker wear rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jacob E. Simmering
Responsible Party
Sponsor Investigator
Principal Investigator

Jacob E. Simmering

Assistant Professor

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Activity tracker wear rate

Time Frame: 14 Days

Percent of time activity tracker records a heart rate

Accuracy of computer vision assessment of motor function

Time Frame: Baseline

Average difference in UPDRS score between human and computer assessments

Do step counts predict quality-of-life

Time Frame: 14 Days

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

Study Sites (1)

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