NCT04891107

Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: MedRhythms, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-02
• Primary completion: 2022-06-08
• Completion: 2022-06-08
• First posted: 2021-05-18
• Last updated: 2023-12-12
• Results posted: 2023-12-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study