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.
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.
Physical barriers in using the wearable device.
Atypical Parkinsonian disorder or other causes of Parkinsonism
Inability to read or write English.
Parallel
Kinesia U
DeviceKinesiaU is a commercially available wearable technology, which includes a smart watch and a mobile application which can continuously monitor and quantify motor symptoms such as tremor, bradykinesia, dyskinesia, gait parameters throughout the day. The technology has been validated for motor symptoms and has high agreement with clinician ratings of motor severity. The motion sensor records data using KinesiaU smart watch and is then transmitted to a secure cloud database, where specialized algorithms analyze the information to detect motor symptoms and compute severity scores every 2 minutes. The results are then not only available to clinicians in the form of detailed reports for review but also for PwP in easily understandable format on the phone application . The validity of this device has been studied to assess tremor, bradykinesia and dyskinesia.
Standard of care treatment
Other interventionParticipants 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.
Recruitment rate
Recruitment rate, defined as the number of participants recruited divided by the number of participants eligible, multiplied by 100. This will indicate how effectively the study was able to enroll suitable participants.
Retention Rate
Retention rate calculated as the number of participants who complete the study divided by those recruited, and the dropout rate as the number of participan
Completion of Intervention:
The proportion of participants adhering to the full intervention will be calculated
MDS Unified Parkinson's Disease Rating Scale Part 3
MDS UPDRS is a validated tool specifically used to assess motor severity in PwP. It measures a range of motor symptoms, including tremor, rigidity, bradykinesia, and postural instability, providing a comprehensive evaluation of motor impairment.
Therapy Adjustments
* Change in medication from baseline to week 4 to capture increase or decrease in dosage, change in medications, adding new medications * Change in advanced therapeutic interventions from baseline to week 4 to capture changes in deep brain stimulation parameters or referral for advanced therapies
Quality of life
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score is a validated patient- reported outcome measure widely used in clinical trials and research to assess the quality of life in individuals with Parkinson's disease (PD). It evaluates the impact of PD on daily life across 8 domains and has 39 questions. Each item is scored on a 5-point Likert scale, where 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, and 4 = Always. The scores for each domain are transformed into a scale of 0 to 100, with higher scores indicating worse health and quality of life.
Adverse events
Adverse events realted to the use of the smart watch
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Western University
Lead sponsor
Academic Medical Organization of Southwestern Ontario
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
