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Clinical Trials/NCT06306768
NCT06306768
Active, not recruiting
Not Applicable

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

Shirley Ryan AbilityLab1 site in 1 country200 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Activity Monitoring
Conditions
Parkinson Disease
Sponsor
Shirley Ryan AbilityLab
Enrollment
200
Locations
1
Primary Endpoint
Physical Activity Metric 1
Status
Active, not recruiting
Last Updated
12 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
March 1, 2028
Last Updated
12 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miriam Rafferty

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

Arms & Interventions

Remote Therapeutic 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.

Intervention: Activity Monitoring

Outcomes

Primary Outcomes

Physical Activity Metric 1

Time Frame: Daily, through study completion, average 1 year

steps per day

Physical Activity Metric 2

Time Frame: Daily, through study completion, average 1 year

Minutes of aerobic physical activity per day (moderate to vigorous physical activity)

Secondary Outcomes

  • Quality of Life from PROMIS 10-b(Completed every 3 months, through study completion, average of 1 year)
  • Quality of Life from PROMIS-29(Completed every 3 months, through study completion, average of 1 year)
  • Exercise Self Efficacy(Completed every other month, through study completion, average of 1 year)

Study Sites (1)

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