NCT04121754

Post-Stroke Walking Speed and Community Ambulation Conversion Study

Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: MedRhythms, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.

Detailed description

Study participants who take part in this research study will participate in a screening visit, fifteen (15) intervention visits over approximately five weeks and a final closing visit. Study participants will be assigned by chance to one of the two study groups. Participants will not be able to switch groups once they are assigned. The investigational device includes a mobile device app and sensors that are attached to shoes. Headphones and a mobile device are also required to be used and will be provided in this study.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
DEVICE	MR-001	Participants will walk using the investigational device (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 3 times a week for 5 weeks.
OTHER	Active Walking	Participants will walk for thirty (30) minutes at a time, 3 times a week for 5 weeks. No mobile devices, music players or headphones will be allowed. They will wear foot sensors during their active walking sessions to measure gait biomechanics.

Timeline

• Start date: 2019-09-17
• Primary completion: 2022-02-11
• Completion: 2022-02-11
• First posted: 2019-10-10
• Last updated: 2023-09-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study