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Patient-Centered PD Ambulatory Monitoring System

ParkinPal: Patient-Centered PD Ambulatory Monitoring System

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04142528
Acronym
ParkinPal
Enrollment
20
Registered
2019-10-29
Start date
2019-07-01
Completion date
2020-06-30
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

DEVICEParkinPal

Wear and periodic recording of motion data during daily wear

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Great Lakes NeuroTechnologies Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Useability6 weeksFollowing the study, patients will complete questionnaires on their experience with the wearable system.

Secondary

MeasureTime frameDescription
Symptom scores6 weeksThe recorded scores will be and timing of medication and exercise diary entries will be examined to measure the effect of therapy and therapy regimen change on symptom scores.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026