NCT06306768

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
22mo left

Started Apr 2024

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Apr 2024Mar 2028

First Submitted

Initial submission to the registry

February 22, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

February 22, 2024

Last Update Submit

April 15, 2026

Conditions

Parkinson DiseaseMultiple Sclerosis

Keywords

physical activityexercise trackingremote therapeutic monitoringquality of lifeself-efficacy

Outcome Measures

Primary Outcomes (2)

  • Physical Activity Metric 1

    steps per day

    Daily, through study completion, average 1 year

  • Physical Activity Metric 2

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

    Daily, through study completion, average 1 year

Secondary Outcomes (3)

  • Exercise Self Efficacy

    Completed every other month, through study completion, average of 1 year

  • 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

Study Arms (1)

Remote Therapeutic Monitoring

OTHER

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.

Device: Activity Monitoring

Interventions

Activity MonitoringDEVICE

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.

Also known as: Datos Health App
Remote Therapeutic Monitoring

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related 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.

    PMID: 27124611BACKGROUND

  • 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.

    PMID: 35084560BACKGROUND

  • 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.

    PMID: 21750523BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMultiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Miriam Rafferty, PT, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 12, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)