Clinical trial NCT04891107: Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease
Official title: Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: MedRhythms, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: Boston University
First posted: 2021-05-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.

Detailed description: Persons with Parkinson disease will be enrolled to determine the effects of a community walking program with a music-based device on adherence, quality of life, walking speed and walking activity. The walking program will be carried out independently by participants in their home/community environment. Noninvasive functional assessments commonly administered in clinical practice will be used to measure the variables of interest.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic, typical Parkinson disease.
* Modified Hoehn and Yahr stages 1-3 per physical exam.
* Able to walk independently without physical assistance or an assistive device.

Exclusion Criteria:

* Diagnosis of atypical Parkinsonism.
* 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.

Primary outcomes:
measure: Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed
timeFrame: 28 days
measure: Safety (Feasibility) Based on the Number of Adverse Events During Training
timeFrame: 28 days
measure: Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire.
timeFrame: 28 days
measure: Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit
timeFrame: 28 days
Secondary outcomes:
measure: Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
timeFrame: 28 days
measure: Change in Walking Endurance (m)
timeFrame: 28 days
measure: Change in Fast Walking Gait Speed (m/s)
timeFrame: 28 days
measure: Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39)
timeFrame: 28 days
measure: Change in Mobility
timeFrame: 28 days
measure: Change in Amount of Walking (Steps/Day)
timeFrame: 8 days
measure: Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min)
timeFrame: 8 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston University College of Health & Rehabilitation: Sargent College
state: Massachusetts
Study officials:
affiliation: College of Health & Rehabilitation Sciences: Sargent College
name: Terry Ellis, PT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Alex Pantelyat, M.D.
role: PRINCIPAL_INVESTIGATOR
References: