NCT06051539

Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: MedRhythms, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess engagement, efficacy, durability, and impact on health care resource utilization of MR-001 in persons with chronic stroke who have a gait deficit after in-home/community use.

Detailed description

This is a decentralized clinical trial designed to assess clinical outcomes and resulting healthcare resource utilization (HCRU) of MedRhythms' MR-001 device used by patients with chronic stroke in the home setting. MR-001 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation intended to improve walking in adult chronic stroke patients. MR-001 is a prescription medical device intended for use at home. The user operates the device autonomously and the therapy progresses automatically once a user engages in a session. The MR-001 system consists of two foot sensors that measure walking, a locked touchscreen device preloaded with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries. The primary objective of this study is to assess engagement with MR-001 walking therapy in chronic stroke patients with a gait deficit in a real world setting. The primary endpoint will be measured by session completion over the 12 week intervention period. Secondary endpoints include assessing effect on walking endurance, durability of response, and reintroduction of the intervention, as well as effect on healthcare resource utilization.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
DEVICE	MR-001	MR-001 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation intended to improve walking and ambulation in adult chronic stroke patients. MR-001 is intended to be a prescription use only device for use at home/community. The user operates the MR-001 System autonomously and the therapy progresses automatically once a user engages in a session. The MR-001 system consists of two foot sensors that measure walking, a touchscreen device preloaded solely with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries. Participants are asked to walk with the device for 3 times per week for 12 weeks. Each walking session is 30 minutes in length.

Timeline

• Start date: 2023-10-10
• Primary completion: 2024-11-30
• Completion: 2025-12-01
• First posted: 2023-09-25
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study