Remote Therapeutic Monitoring Exercise Tracking

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Multiple Sclerosis; Parkinson Disease

Treatments: Device: Activity Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06306768

STU00219979

Details and patient eligibility

About

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.

Full description

Remote therapeutic monitoring (RTM) is a reimbursable clinical service. Pilot investigation conducted by our lab demonstrated promise that this service is feasible to add to clinical care. It is unclear still if RTM is able to provide clinical benefit to patients including improving and sustaining physical activity (PA) and exercise behaviors over a longer period of time (>1 year). Our central hypothesis is that the addition of RTM to physical activity, both in a skilled rehabilitation program and within a home program, will improve long term outcomes related to physical activity including self-efficacy for exercise, consistent participation in home exercise recommendations, and quality of life in people living with PD and MS. Thus the specific aims of this study are as follows:

1. To assess PA and exercise behaviors over 1-year period using a remote therapeutic monitoring platform

   a. We will track steps per day, minutes of aerobic activity per week, and frequency of workouts including flexibility, balance, and resistance training.

2. To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.

   1. Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community
• Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis
• Personal goal and willingness to address physical activity
• Have a smart phone (Datos Health app is compatible with any Smart phone device)
• Willing to accept Datos' Terms and Conditions

Exclusion criteria

• Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Remote Therapeutic Monitoring

Other group

Description:

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.

Treatment:

Device: Activity Monitoring