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Remote Therapeutic Monitoring Exercise Tracking

Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06306768
Enrollment
200
Registered
2024-03-12
Start date
2024-04-01
Completion date
2028-03-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Multiple Sclerosis

Keywords

physical activity, exercise tracking, remote therapeutic monitoring, quality of life, self-efficacy

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.

Interventions

Tracking participants step activity, workout frequency, minutes in target heart rate zone, and type of exercises completed over 1 year period. Goals will be set and customized by a research physical therapist to participants based on best practice recommendations.

Sponsors

Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical Activity Metric 1Daily, through study completion, average 1 yearsteps per day
Physical Activity Metric 2Daily, through study completion, average 1 yearMinutes of aerobic physical activity per day (moderate to vigorous physical activity)

Secondary

MeasureTime frameDescription
Exercise Self EfficacyCompleted every other month, through study completion, average of 1 yearsums of 9 items with total scores ranging from 0-90; higher scores indicating higher self-efficacy.
Quality of Life from PROMIS 10-bCompleted every 3 months, through study completion, average of 1 yearPROMIS 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-29Completed every 3 months, through study completion, average of 1 yearPROMIS-29 measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and sleep disturbance).

Countries

United States

Contacts

Primary ContactMiriam Rafferty, PT, PhD
mrafferty@sralab.org312-238-7233
Backup ContactHannah Redd, PT, DPT
hredd@sralab.org312-238-1688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026