Remote Therapeutic Monitoring Exercise Tracking
- Conditions
- Multiple SclerosisParkinson Disease
- Interventions
- Device: Activity Monitoring
- Registration Number
- NCT06306768
- Lead Sponsor
- Shirley Ryan AbilityLab
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Remote Therapeutic Monitoring Activity Monitoring 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.
- Primary Outcome Measures
Name Time Method Physical Activity Metric 1 Daily, through study completion, average 1 year steps per day
Physical Activity Metric 2 Daily, through study completion, average 1 year Minutes of aerobic physical activity per day (moderate to vigorous physical activity)
- Secondary Outcome Measures
Name Time Method Quality of Life from PROMIS 10-b Completed every 3 months, through study completion, average of 1 year PROMIS 10-b short form which is 10 items measuring mobility difficulty, scores are summed and then translated to t-score.
Quality of Life from PROMIS-29 Completed every 3 months, through study completion, average of 1 year PROMIS-29 measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and sleep disturbance).
Exercise Self Efficacy Completed every other month, through study completion, average of 1 year sums of 9 items with total scores ranging from 0-90; higher scores indicating higher self-efficacy.
Trial Locations
- Locations (1)
Shirley Ryan AbilityLab
🇺🇸Chicago, Illinois, United States