Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease
Purpose
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.
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System |
|
More Details
- Status
- Completed
- Sponsor
- MedRhythms, Inc.
Study Contact
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.