SMART-PD: Evaluating the Impact of Smartphone-Based Wearable Technology on Motor Symptoms and Quality of Life in People With Parkinson's Disease (SMART PD)

Western University

Status: Not yet enrolling

Conditions: Parkinson Disease, Idiopathic

Treatments: Device: Kinesia U; Other: Standard of care treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07066163

126861

Details and patient eligibility

About

This study aims to evaluate whether wearable technology can improve the management of motor symptoms in people with Parkinson's disease (PD) who experience motor fluctuations throughout the day. The project will use a smartwatch and mobile app (KinesiaU) to continuously track movement, allowing for more responsive and personalized treatment compared to traditional monitoring methods.

In this pilot randomized controlled trial, 32 participants will be assigned to either:

A control group receiving standard care, or

A wearable device group receiving standard care plus using the smartwatch.

Outcomes will be assessed over a 4-week period, focusing on changes in motor function, quality of life, and self-management. The study will also examine feasibility, adherence, and data quality.

If successful, this trial will provide critical evidence for integrating wearable devices into routine clinical care for PD, paving the way for larger efficacy trials and more patient-centered care strategies.

Full description

Parkinson's disease (PD) is a common brain disorder that affects movement. It usually develops later in life and gradually worsens over time. People with Parkinson's may experience symptoms such as shaking (tremor), slow movement (bradykinesia), muscle stiffness, and problems with walking or balance. What makes Parkinson's especially challenging is that these symptoms can change throughout the day - a person may feel relatively well one moment and struggle to move just hours later.

Why is this a problem? This daily fluctuation in symptoms - known as motor fluctuations - makes it difficult for both patients and doctors to manage the disease. Traditional ways of monitoring symptoms, like keeping a diary or waiting until the next doctor's visit, don't always capture the full picture of what's happening. This can lead to treatment plans that don't match a person's actual needs.

What is the study about? We are exploring whether using wearable technology - in this case, a smartwatch and mobile app called KinesiaU - can help people with Parkinson's and their doctors better track and manage symptoms. The smartwatch measures movement throughout the day and sends data to a mobile app. This gives a more accurate and detailed view of how symptoms change over time, outside of the doctor's office.

Who is involved in the study?

The study will include 32 people living with Parkinson's disease who are experiencing motor fluctuations. They will be randomly divided into two groups:

Group 1: Standard Care Group - These participants will continue their regular care, which may include doctor visits, motor symptom diaries, and interviews with their care team.

Group 2: Wearable Device Group - These participants will also receive standard care plus use the KinesiaU smartwatch and app. They will wear the device at least five days a week, and the information it collects will be used by their doctors to make timely and personalized treatment decisions.

How will the study work?

Everyone in the study will be assessed at the beginning, then again at Week 2 and Week 4. During these check-ins,Investigators will measure:

Changes in movement symptoms using a standard clinical scale (MDS-UPDRS III)

Quality of life (using a questionnaire called PDQ-39)

How confident patients feel in managing their health (using a tool called PAM-13)

Investigators will also track whether people are willing and able to stick with the program, how often they wear the device, and whether the data collected is complete and usable.

Why is this study important? This is the first pilot study in our region to test this kind of wearable technology for people with Parkinson's. If it goes well, it will show that using a smartwatch is not only possible and helpful, but also something people are willing to do. The results will guide a larger study in the future and could help bring this kind of technology into routine clinical care.

The goal is to make Parkinson's care more personalized, data-driven, and responsive to real life. Investigators believe that by using innovative tools like smartwatches, we can give people living with Parkinson's more control over their health and improve their quality of life.

Enrollment: 32 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet criteria for Parkinson's disease using MDS Clinical Diagnostic Criteria for Parkinson's Disease
• Presence of Motor fluctuations based on movement disorder neurologist assessment.
• Motor ability to use the wearable device and access the wearable device application.
• Cognitively ability to do ADL's and use the wearable device and access the wearable device application based on clinician's judgment.
• Knowledge of English to enter medication details in the wearable device application.

Exclusion criteria

• Physical barriers in using the wearable device.
• Atypical Parkinsonian disorder or other causes of Parkinsonism
• Inability to read or write English.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Wearable device group (WDG):

Experimental group

Description:

Participants who were randomized to the WDG will receive a smart watch and a mobile phone with KinesiaU application loaded. Participants will get hands on training on the first visit about how to use the smartwatch, how to enter medication details and access the reports on the phone. They will be instructed to wear the smartwatch for at least five out of seven days following the first visit.

Treatment:

Device: Kinesia U

control group

Other group

Description:

Participants in the control group will receive standard of care, consisting of regular management of their motor symptoms and monitoring using motor dairy, interview by their neurologist, family physician, and other healthcare providers. n.

Treatment:

Other: Standard of care treatment