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

NCT07066163 | Not Yet Recruiting

• 1 other identifier: 126861
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease, Idiopathic

Keywords

parkinson; wearable

Outcome Measures

Primary Outcomes (3)

• 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.

  Through study completion, an average of 1 year".

• 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

  Through study completion, around 1year

• Completion of Intervention:

  The proportion of participants adhering to the full intervention will be calculated

  Through study completion, around 1year

Secondary Outcomes (1)

• MDS Unified Parkinson's Disease Rating Scale Part 3

  4 weeks

Other Outcomes (3)

• Therapy Adjustments

  4 weeks

• Quality of life

  4 WEEKS

• Adverse events

  4 weeks

Study Arms (2)

Wearable device group (WDG):

EXPERIMENTAL

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.

Device: Kinesia U

control group

OTHER

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.

Other: Standard of care treatment

Interventions

Kinesia U DEVICE

KinesiaU 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.

Wearable device group (WDG):

Standard of care treatment OTHER

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.

control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Western University: lead
• Academic Medical Organization of Southwestern Ontario: collaborator

Study Sites (2)

London Health Sciences Center.London ,Ontario

London, Ontario, N5X 1A4, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

deepa dash

CONTACT

15196633187; deepa.dash@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: video based assessment without knowledge of arm
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CA (2)