Patient-Centered PD Ambulatory Monitoring System
ParkinPal
ParkinPal: Patient-Centered PD Ambulatory Monitoring System
2 other identifiers
observational
20
1 country
1
Brief Summary
This a usability study of a wearable sensor platform that utilizes a smartwatch to periodically record motion data. That data is processed in a connected smartphone and translated into symptom scores for dyskinesia, slowness, and tremor. The research subjects will use the wearable system over the course of five weeks, during which a change in therapy regimen is prescribed by the physician. Research analysis will be focused on patient and clinician experiences with the app and its reports.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedOctober 29, 2019
October 1, 2019
1 year
October 25, 2019
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Useability
Following the study, patients will complete questionnaires on their experience with the wearable system.
6 weeks
Secondary Outcomes (1)
Symptom scores
6 weeks
Study Arms (1)
Parkinson's Disease
Smartwatch-based sensor assessment of PD symptoms during standard care
Interventions
Wear and periodic recording of motion data during daily wear
Eligibility Criteria
The population is people with Parkinson's Disease who are patients of David E. Riley, MD. Therefore most participants will reside in the northeast Ohio area.
You may qualify if:
- Existing Patient of Collaborating Physician (David E. Riley, MD)
- Diagnosed With Parkinson's Disease
- Hoehn \& Yahr Scale I-III
- Ambulatory and capable of using the ParkinPal system
- Able to understand and follow instructions regarding using the device
You may not qualify if:
- Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
David E. Riley, MD
Warrensville Heights, Ohio, 44128, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dustin Heldman, PhD
Great Lakes NeuroTechnologies
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2019
First Posted
October 29, 2019
Study Start
July 1, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
October 29, 2019
Record last verified: 2019-10