What side effects are associated with this type of intervention?

Common treatments for stroke, particularly those focusing on gait rehabilitation, include physical therapy, repetitive facilitation exercises, and the use of orthotic devices. Side effects of these treatments are generally minimal but can include muscle soreness, fatigue, and, in rare cases, joint or muscle strain. Advanced therapies like robotic-assisted gait training or rhythmic auditory stimulation may also be used, with potential side effects including discomfort from device use and, occasionally, skin irritation. Overall, these treatments are considered safe and beneficial for improving mobility post-stroke.

What prior FDA approvals exist?

The FDA has approved various treatments for stroke, primarily focusing on acute management and secondary prevention. These include thrombolytic agents like alteplase (tPA) for acute ischemic stroke and antiplatelet drugs such as aspirin and clopidogrel for secondary prevention. For rehabilitation, while specific devices like MR-001 (a gait rehabilitation device) are under study, the FDA has approved other rehabilitation therapies and devices aimed at improving motor function post-stroke. These include robotic-assisted therapy devices and transcranial magnetic stimulation (TMS), which have shown promise in enhancing motor recovery and gait rehabilitation in stroke patients.

What other types of research exist?

Promising alternatives to MR-001 for gait rehabilitation in stroke patients include: 1) Rhythmic Auditory Stimulation (RAS), which uses rhythmic cues to improve gait patterns; 2) Robotic-assisted gait training devices like the Lokomat, which provide automated, repetitive movement training; 3) Virtual reality-based rehabilitation, which offers immersive environments to enhance motor learning and engagement; and 4) Functional Electrical Stimulation (FES), which stimulates muscles to produce functional movements. These alternatives have shown potential in improving gait and mobility in stroke patients.

← Back to Search

Rhythmic Auditory Stimulation Device for Stroke (OrcHESTRAS Trial)

N/A

Recruiting

Led By Francois Bethoux, MD

Research Sponsored by MedRhythms, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to ambulate without assistance from another person. Note: assistive devices are allowed. If a participant uses an assistive device at the time of enrollment, the device must be used for all walking sessions.

Able to walk at a speed greater than or equal to 0.4 m/s as derived as an average of speed per minute from the 6MWT. Note: if a participant intends to use an assistive device throughout the intervention period, the assistive device must be used during the gait assessment.

Must not have

Pain that impairs walking ability

Requires more than one rest (seated or not) during the 6MWT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the MR-001 device, which helps stroke patients improve their walking using rhythmic sounds. It targets adults with chronic stroke who have trouble walking. The device tracks steps and adjusts therapy automatically to aid in walking improvement.

Who is the study for?

This trial is for adults aged 18-85 who had a stroke at least 6 months ago and now have trouble walking. They must be able to walk on their own (with devices if needed), speak English, and agree to share health data. People with severe hearing loss, pain affecting walking, recent major surgery, or conditions like Parkinson's can't join.

What is being tested?

The study tests MR-001's ability to improve walking in chronic stroke patients when used at home or in the community. It looks at how well people stick with it, its effectiveness over time, and its impact on healthcare costs.

What are the potential side effects?

Since MR-001 involves rhythmic auditory stimulation for gait improvement after stroke, side effects are not typical as with medications; however, any discomfort or issues experienced during use will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk on my own, but I may use a device like a cane or walker.

Select...

I can walk faster than 0.4 meters per second, even if I need to use an assistive device.

Select...

I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My pain stops me from walking properly.

Select...

I need to rest more than once during a 6-minute walk test.

Select...

I do not have any major health issues that would affect my ability to walk or exercise safely.

Select...

I use a prosthetic for my lower limb.

Select...

I have fallen more than twice in the last month.

Select...

I walk with a normal two-step pattern.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of walking sessions during 12-week intervention period

Secondary study objectives

PROMIS Social Isolation Scale

Patient Health Questionnaire-8 (PHQ-8)

The Barthel Index

+1 more

Other study objectives

6 Minute Walk Test (6MWT)

All-cause HCRU

All-cause hospitalizations and emergency department visits

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort A: Restart InterventionExperimental Treatment1 Intervention

Participants in Cohort A will perform active walking for 30 minutes at a time with MR-001, at least 3 times a week, for 12 weeks in their home/community environment.

Group II: Cohort B: Continued WashoutActive Control1 Intervention

Participants in Cohort B will continue their washout period for another 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MR-001

2019

N/A

~90

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke, particularly those aimed at improving gait and mobility, include physical therapy, robotic-assisted gait training, and rhythmic auditory stimulation. Physical therapy focuses on repetitive, task-specific exercises to enhance neuroplasticity and muscle strength. Robotic-assisted gait training uses devices to provide consistent, controlled movement patterns, helping to retrain the brain and muscles for walking. Rhythmic auditory stimulation employs rhythmic cues to improve coordination and timing of movements. These treatments are crucial for stroke patients as they promote recovery of motor function, enhance independence, and improve overall quality of life.