Activity Monitoring for Parkinson's Disease and Multiple Sclerosis

Overseen By Hannah Redd, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Dementia, Cognitive disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how individuals with Parkinson's Disease and Multiple Sclerosis maintain activity over a year. It employs a health app and an activity tracker to monitor daily exercise and physical activity through Remote Therapeutic Monitoring Exercise Tracking. The goal is to assess how these tools can aid in managing these conditions. This trial targets those who can walk with minimal assistance, have Parkinson's or Multiple Sclerosis, and wish to improve their physical activity. Participants need a smartphone and must be willing to use a health app. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance daily life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this remote therapeutic monitoring is safe for people with Parkinson's Disease and Multiple Sclerosis?

Research has shown that using remote tools like exercise tracking apps and devices is safe for people with Parkinson's Disease and Multiple Sclerosis. One study found that telerehabilitation, which uses similar remote monitoring, was safe, easy to use, and effective for people with mild-to-moderate Parkinson's. Thus, tracking activity through an app or device should not cause harm. It helps monitor physical activity and exercise without any serious side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the remote therapeutic monitoring for Parkinson's Disease and Multiple Sclerosis because it offers a new way to track and manage these conditions using technology. Unlike traditional treatments that rely on medication or in-person therapy, this approach uses a connected health app and a personal activity tracker to monitor physical activity and exercise behaviors remotely. This method empowers patients to engage in their care actively and allows doctors to adjust treatments based on real-time data, potentially leading to more personalized and effective management of symptoms.

What evidence suggests that remote therapeutic monitoring is effective for Parkinson's Disease and Multiple Sclerosis?

Research shows that remote patient monitoring (RPM), which participants in this trial will receive, effectively tracks physical activity in people with Parkinson's Disease and Multiple Sclerosis. This helps doctors make better decisions about patient care. Studies have shown that monitoring exercise and movement can lead to better health outcomes for these conditions. RPM uses technology to track activity levels and encourages more movement, which is important for managing symptoms. While interest in this technology is growing, more evidence is needed to fully understand its impact on health outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Miriam Rafferty, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for people who can walk on their own or with a cane, have Parkinson's Disease (mild to moderate stages), Parkinsonism, or Multiple Sclerosis. They should be willing to increase physical activity and must agree to the terms of using a remote monitoring app on their smartphone.

Inclusion Criteria

I can walk on my own or with a cane.

I have been diagnosed with Parkinson's disease, Parkinsonism, or Multiple Sclerosis.

I am willing to work on improving my physical activity.

Exclusion Criteria

I do not have any cognitive or communication issues that would prevent me from using a remote monitoring tool.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote Therapeutic Monitoring

Participants receive 1 year of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors.

52 weeks

Monthly self-report surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Therapeutic Monitoring Exercise Tracking

Trial Overview The study is testing how well a cloud-based remote monitoring platform tracks exercise and physical activity in individuals with Parkinson's Disease or Multiple Sclerosis over one year.

How Is the Trial Designed?

Group I: Remote Therapeutic Monitoring Experimental Treatment 1 Intervention

Participants will receive 1 year of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

In a study of 629 participants with multiple sclerosis, 40% reported using activity monitors, such as Fitbit and Apple Watch, which were linked to higher levels of self-reported physical activity.

Users of activity monitors had significantly higher scores on the Godin Leisure-Time Exercise Questionnaire, indicating they engaged in more total and health-promoting physical activity compared to non-users, suggesting that these devices could be effective tools for encouraging physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity monitor use among persons with multiple sclerosis: Report on rate, pattern, and association with physical activity levels. Silveira, SL., Motl, RW.[2023]

Remote patient monitoring (RPM) is a practical tool for tracking physical activity in outpatient care, providing more reliable data than self-reports, as demonstrated in four pilot studies across various medical specialties.

RPM can enhance the management of chronic diseases and rehabilitation by offering clinicians objective feedback on patient progress, although attention must be given to ensure all populations can access these digital health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. McCarthy, M., Jevotovsky, D., Mann, D., et al.[2023]

The proposed protocol allows for remote motor assessments of Parkinson's disease patients using recorded videos or live virtual assessments, addressing challenges like distance and infection risk between patients and examiners.

This remote assessment framework enables healthcare providers to conduct structured evaluations necessary for accurate diagnosis and personalized treatment plans, enhancing access to care for patients in diverse locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of virtual low-cost quantitative continuous measurement of movements in the extremities of people with Parkinson's disease. Elshourbagy, A., Eltaras, MM., Abdalshafy, H., et al.[2023]

Remote activity monitoring (RAM) using wearable technology is a valid and acceptable method for measuring outcomes in people with progressive multiple sclerosis (MS), as demonstrated in a study with 56 participants over 2.5 years.

The RAM device showed high tolerance among users, with a wear time of 99.4%, and its measurements, particularly step count, correlated positively with brain volume loss, indicating its potential effectiveness in tracking disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity monitoring to assess disability progression in multiple sclerosis. Stuart, CM., Varatharaj, A., Domjan, J., et al.[2022]

In a study of 50 adults with multiple sclerosis (MS), daily step counts measured by a Fitbit were found to correlate significantly with disability levels and structural brain and spinal cord measures, suggesting that physical activity is linked to neurological health in MS patients.

The research indicates that greater daily physical activity is associated with larger gray matter areas in the spinal cord and overall brain volume, highlighting the potential of using step counts as a simple indicator of changes in central nervous system pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of daily physical activity with brain volumes and cervical spinal cord areas in multiple sclerosis. Block, VJ., Cheng, S., Juwono, J., et al.[2023]

Remote physical activity monitoring is feasible and effective in assessing activity levels in adults with neurological diseases, with 137 studies reviewed across various conditions such as multiple sclerosis, stroke, and Parkinson's disease.

Findings indicate that low physical activity levels are common in conditions like multiple sclerosis and dementia, while in stroke, remote monitoring can aid in tracking recovery and in Parkinson's disease, it may help predict falls, highlighting the potential for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. Block, VA., Pitsch, E., Tahir, P., et al.[2022]

A vision-based solution using the Azure Kinect DK sensor has been developed to remotely assess and rehabilitate Parkinson's disease patients, allowing for non-invasive 3D tracking of body movements and monitoring of motor performance.

In a study with 20 Parkinsonian subjects and 15 healthy controls, the system demonstrated significant ability to quantify motor performance changes over time and showed a 14% reduction in arm swing asymmetry after targeted training, indicating its potential for effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment Tasks and Virtual Exergames for Remote Monitoring of Parkinson's Disease: An Integrated Approach Based on Azure Kinect. Amprimo, G., Masi, G., Priano, L., et al.[2023]

A survey of 3172 patients enrolled in a remote patient monitoring (RPM) program showed that 88.97% felt comfortable managing their health from home, indicating high patient engagement and satisfaction with the program.

93.58% of participants expressed readiness to graduate from the RPM program after meeting their health goals, and 92.76% would recommend RPM to others, demonstrating the program's effectiveness in managing both acute and chronic conditions outside of traditional healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. Haddad, TC., Maita, KC., Inselman, JW., et al.[2023]

Remote patient monitoring (RPM) in total joint arthroplasty utilizes telecommunication and wearable or implantable technology to enhance postoperative care, allowing for better assessment and treatment of patients.

The review highlights the benefits of RPM for both patients and physicians, while also addressing important factors like insurance coverage and reimbursement for these innovative monitoring technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring Following Total Joint Arthroplasty. Weinberg, M., Danoff, JR., Scuderi, GR.[2023]

A retrospective review of 31 patients from the Mississippi Diabetes Telehealth Network Study revealed that African American participants experienced a significant increase in HbgA1c levels after the remote patient monitoring program ended, indicating a higher risk for worsening diabetes management post-intervention.

No other demographic factors, such as income or age, significantly influenced changes in HbgA1c levels, suggesting that targeted strategies may be necessary to support African American patients in maintaining their health outcomes after RPM programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of Remote Patient Monitoring in Patients Living with Diabetes: A Retrospective Look at Participants of the Mississippi Diabetes Telehealth Network Study. Davis, TC., Allen, AS., Zhang, Y.[2022]

The study evaluated remote monitoring methods for Multiple Sclerosis (MS) using the remotely patient-recorded timed 25-foot walk (rT25FW) and nine-hole peg test (r9HPT) with 179 participants, showing a positive correlation between the rT25FW and the webEDSS, indicating its potential effectiveness in assessing mobility.

While the rT25FW showed promise, the r9HPT did not correlate significantly with the webEDSS, suggesting that while remote monitoring is valid, it needs further refinement before being widely used in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of remote assessments for multiple sclerosis in an in-home setting. Kuri, A., Jacobs, BM., Leddy, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06306768

NCT06306768 | Remote Therapeutic Monitoring Exercise ... The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1- ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06306768/remote-therapeutic-monitoring-exercise-tracking

Remote Therapeutic Monitoring Exercise Tracking The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis ...

3. withpower.com withpower.com/trial/phase-multiple-sclerosis-2-2024-a4bb1

Activity Monitoring for Parkinson's Disease and Multiple Sclerosis Research shows that remote patient monitoring (RPM) can reliably track physical activity, which helps doctors make better decisions about patient care. This ...

4. nationalmssociety-org.clinicaltrialconnect.com nationalmssociety-org.clinicaltrialconnect.com/trials/NCT06306768

Remote Therapeutic Monitoring Exercise Tracking - National ... The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6550143/

Impact of remote patient monitoring on clinical outcomes Despite growing interest in remote patient monitoring, limited evidence exists to substantiate claims of its ability to improve outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9245570/

Feasibility, Safety, and Effectiveness of Telerehabilitation in ... Our findings demonstrate that telerehabilitation is safe, feasible, and effective on motor symptoms in mild-to-moderate PD patients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11039525/

Attitudes Toward the Adoption of Remote Patient Monitoring ... These devices offer objective, continuous tracking of PD symptoms within the patient's natural living environment, capturing a range of data ...