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Behavioural Intervention
MR-010 Device for Stroke
N/A
Recruiting
Led By Brian Silver, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be within 24 hours from admission for confirmed stroke event.
Currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as determined by a 10-meter walk test for comfortable walking speed (the average of three trials).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
Study Summary
This trial will test a new medical device to see if it can help improve outcomes for stroke patients.
Who is the study for?
This trial is for adults over 18 who've had a stroke within the last 24 hours, can walk at certain speeds with some gait asymmetry, and speak English fluently. They must be able to participate in physical therapy and consent to study procedures. Excluded are those with recent orthopedic surgery, severe communication disorders, hearing impairments, or other serious health issues.Check my eligibility
What is being tested?
The MR-010's effects on walking ability post-stroke are being tested. This includes its impact on tolerability, biomechanics of walking, speed improvement during recovery in acute care settings, and whether it affects hospital stay duration.See study design
What are the potential side effects?
Since MR-010 is designed to aid stroke rehabilitation through walking therapy sessions rather than medication or invasive treatment, specific side effects aren't listed but may include general fatigue or discomfort from increased physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted for a stroke less than 24 hours ago.
Select...
I can walk at a speed between 0.4m/s and 1.0m/s.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to MR-010 therapy schedule
Change in gait speed (m/s)
Secondary outcome measures
Length of stay
Readmission to hospital
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MR-010 walking therapyExperimental Treatment1 Intervention
Subjects will use the MR-010 three times a week for 30 minutes per session for 90 days. Subjects will undergo a 10-meter walk test bi-weekly and at 45 and 90 days.
Group II: Standard of CareActive Control1 Intervention
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
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Who is running the clinical trial?
MedRhythms, Inc.Industry Sponsor
6 Previous Clinical Trials
423 Total Patients Enrolled
3 Trials studying Stroke
343 Patients Enrolled for Stroke
University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,570 Total Patients Enrolled
5 Trials studying Stroke
811 Patients Enrolled for Stroke
Brian Silver, MDPrincipal InvestigatorUMass Medical School
5 Previous Clinical Trials
20 Total Patients Enrolled
4 Trials studying Stroke
20 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other health problems that make it hard for you to exercise, such as issues with muscles, heart, lungs, or nerves (except for stroke).I was admitted for a stroke less than 24 hours ago.I agree to follow the study plan and communicate with my doctor as needed.You use a prosthetic leg.I can walk at a speed between 0.4m/s and 1.0m/s.I will need physical therapy after leaving the hospital and have agreed to attend at least one session.I have severe difficulty speaking or understanding language.I am unable or unwilling to give my consent for participation.I have a history of brain or nerve problems, not including stroke.I had surgery on my bones or joints in the past year.I am 18 years old or older.You have trouble hearing.I walk unevenly.You have a low score on questions about stroke symptoms on a scale used by doctors.I can safely do 30-minute walking sessions as part of the study.
Research Study Groups:
This trial has the following groups:- Group 1: MR-010 walking therapy
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are accepted into this trial?
"Correct. The clinical trial website confirms that this research is enlisting participants for the study which was originally posted on November 1st 2021. 40 people are required from a single medical facility."
Answered by AI
Are there any ongoing recruitment efforts for this clinical investigation?
"According to clinicaltrials.gov, this medical experiment is currently looking for participants; the trial was initially launched on November 1st 2021 and last revised on February 8th 2022."
Answered by AI
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