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

Trial Summary

What is the purpose of this trial?

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-year using a cloud-based remote monitoring platform.

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 data supports the effectiveness of the treatment Remote Therapeutic Monitoring Exercise Tracking, Remote Therapeutic Monitoring (RTM), Remote Patient Monitoring (RPM), Telehealth Exercise Tracking 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 approach is especially useful for people with neurological diseases like Parkinson's and MS, as it allows for continuous monitoring without needing to visit a clinic. ^{1 2 3 4 5}

Is remote patient monitoring safe for humans?

Remote patient monitoring (RPM) has been used safely in various conditions, including diabetes and joint surgery recovery, to help manage health at home. It involves using technology to track health data, and there are no reports of significant safety concerns in the studies reviewed. ^{1 2 6 7 8}

How does activity monitoring differ from other treatments for Parkinson's Disease and Multiple Sclerosis?

Activity monitoring for Parkinson's Disease and Multiple Sclerosis is unique because it uses wearable technology to remotely track physical activity, allowing for real-world assessment of motor function and disability at home. This approach is particularly beneficial for continuous monitoring without the need for frequent hospital visits, making it a flexible and accessible option compared to traditional in-person assessments. ^{1 5 9 10 11}

Research Team

Miriam Rafferty, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical activity monitoring to assess disability progression in multiple sclerosis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of virtual low-cost quantitative continuous measurement of movements in the extremities of people with Parkinson's disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Association of daily physical activity with brain volumes and cervical spinal cord areas in multiple sclerosis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring Following Total Joint Arthroplasty. [2023]

7. United States 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. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment Tasks and Virtual Exergames for Remote Monitoring of Parkinson's Disease: An Integrated Approach Based on Azure Kinect. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of remote assessments for multiple sclerosis in an in-home setting. [2021]