Parkinson Disease, IdiopathicSMART PDNCT07066163
SMART-PD: Evaluating the Impact of Smartphone-Based Wearable Technology on Motor Symptoms and Quality of Life in People With Parkinson's Disease
A study testing Kinesia U in people with Parkinson Disease, Idiopathic, run by Western University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- Kinesia U
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Physical barriers in using the wearable device.
- Atypical Parkinsonian disorder or other causes of Parkinsonism
- Inability to read or write English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
London Health Sciences Center.London ,Ontario
London, Ontario, N5X 1A4
Deepa Dash, 5196633187, drddash@yahoo.com
London Health Sciences Center
London, Ontario, N6A 5A5
5196633187, deepa.dash@lhsc.on.ca
About this study
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:
Read more
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.
Read the detailed 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.
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- Kinesia U, Standard of care treatment
- Keywords
- parkinson, wearable
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesia UDevice
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.
Standard of care treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Through study completion, around 1year
Completion of Intervention:
The proportion of participants adhering to the full intervention will be calculated
Measured: Through study completion, around 1year
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Responsible party
- Principal investigator, Deepa Dash, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066163
- Sponsor's protocol ID
- 126861
- Acronym
- SMART PD
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As a small-scale feasibility study involving only 32 participants, the dataset may not be robust enough to support secondary analyses or generalizable conclusions. Sharing such limited data could risk misinterpretation or misuse.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-PD: Evaluating the Impact of Smartphone-Based Wearable Technology on Motor Symptoms and Quality of Life in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07066163
- Acronym / sponsor ID
- SMART PD / 126861
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- parkinson, wearable
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable device group (WDG): | Experimental | Device: Kinesia UParticipants 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. |
| control group | Other | Other: Standard of care treatmentParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Physical barriers in using the wearable device.
- Atypical Parkinsonian disorder or other causes of Parkinsonism
- Inability to read or write English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesia UKinesiaU 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. | Device | Wearable device group (WDG): |
| Standard of care treatmentParticipants 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. | Other | control group |
Primary outcome
Recruitment rate
Time frame: Through study completion, an average of 1 year".
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
Time frame: Through study completion, around 1year
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:
Time frame: Through study completion, around 1year
The proportion of participants adhering to the full intervention will be calculated
1 secondary outcome
MDS Unified Parkinson's Disease Rating Scale Part 3
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided. As a small-scale feasibility study involving only 32 participants, the dataset may not be robust enough to support secondary analyses or generalizable conclusions. Sharing such limited data could risk misinterpretation or misuse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesia U in people with Parkinson Disease, Idiopathic, run by Western University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact deepa dash (15196633187, deepa.dash@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion, an average of 1 year".). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.