Remote Therapeutic Monitoring Exercise Tracking

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306768
• Other study ID #: STU00219979
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 2028

Study information

• Verified date: April 2024
• Source: Shirley Ryan AbilityLab
• Contact: Miriam Rafferty, PT, PhD
• Phone: 312-238-7233
• Email: mrafferty[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Sclerosis

Intervention

Device:
• Activity Monitoring
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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

References & Publications (3)

Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016. — View Citation

Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 Jun;269(6):2922-2940. doi: 10.1007/s00415-021-10935-6. Epub 2022 Jan 27. — View Citation

Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Metric 1	steps per day	Daily, through study completion, average 1 year
Primary	Physical Activity Metric 2	Minutes of aerobic physical activity per day (moderate to vigorous physical activity)	Daily, through study completion, average 1 year
Secondary	Exercise Self Efficacy	sums of 9 items with total scores ranging from 0-90; higher scores indicating higher self-efficacy.	Completed every other month, through study completion, average of 1 year
Secondary	Quality of Life from PROMIS 10-b	PROMIS 10-b short form which is 10 items measuring mobility difficulty, scores are summed and then translated to t-score.	Completed every 3 months, through study completion, average of 1 year
Secondary	Quality of Life from PROMIS-29	PROMIS-29 measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and sleep disturbance).	Completed every 3 months, through study completion, average of 1 year