Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community 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

ArmDescriptionAssigned Intervention
Experimental
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Will walk for 30 minutes at a time, 5 times a week, for 4 weeks using the wearable sensor system at home or in the community.
  • Device: 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 names:
    • MedRhythms MR-005 Device

Recruiting Locations

Boston University College of Health & Rehabilitation: Sargent College
Boston, Massachusetts 02215
Contact:
Jenna Zajac, DPT
617-419-0704
zajacj@bu.edu

More Details

Status
Recruiting
Sponsor
MedRhythms, Inc.

Study Contact

Clinical Affairs
617-356-7822
study@medrhythms.com

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.