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Active, Not Recruiting

NCT Number: NCT06306768

Remote Therapeutic Monitoring Exercise Tracking

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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:

  • 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.

  • To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.
  • Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Monitoring

Device

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.

Other names: Datos Health App

Primary outcomes

  1. Physical Activity Metric 1

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

    steps per day

  2. 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

  1. Exercise Self Efficacy

    Time frame: 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.

  2. Quality of Life from PROMIS 10-b

    Time frame: 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.

  3. Quality of Life from PROMIS-29

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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