Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease
NCT ID: NCT04891107
Last Updated: 2023-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2021-07-02
2022-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Participants will walk using the music-based, rhythm-modulating wearable sensor system (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 5 times a week for 4 weeks.
Interventions
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Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Participants will walk using the music-based, rhythm-modulating wearable sensor system (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 5 times a week for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Modified Hoehn and Yahr stages 1-3 per physical exam.
* Able to walk independently without physical assistance or an assistive device.
Exclusion Criteria
* Moderately or significantly disturbing freezing episodes during daily walking.
* Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
* Significant hearing impairment.
* Currently participating in physical therapy.
* Cardiac problems that interfere with the ability to safely exercise.
* Orthopedic problems in the lower extremities or spine that may limit walking distance.
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Boston University
OTHER
MedRhythms, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Terry Ellis, PT, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
College of Health & Rehabilitation Sciences: Sargent College
Alex Pantelyat, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston University College of Health & Rehabilitation: Sargent College
Boston, Massachusetts, United States
Countries
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References
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Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CM082000501
Identifier Type: -
Identifier Source: org_study_id