Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 2:13 AM
Study NCT ID:
NCT06306768
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Therapeutic Monitoring Exercise Tracking
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: