Stroke, AcuteNCT04689256

Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke

A study testing MR-010 in people with Stroke, Acute, run by University of Massachusetts, Worcester at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this clinical pilot study is to evaluate the effects of the MR-010 on tolerability, biomechanics and walking speed in the acute stroke care setting in addition to its impact on length of stay. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Acute
What is being tested?: MR-010
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 3 Nov 2021to 30 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be 18 years of age or older.
Must be able to read and speak English fluently.
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).
Demonstrates some level of asymmetry in gait.
Is expected to be discharged from the acute care setting requiring physical therapy per standard of care and participant has verbally committed to receiving at least one therapy session.

Show all 9Show fewer

Able and willing to consent with proposed study schema (verbal commitment), including consent to participate in communication with the treating clinician (as needed) during the study period.
Score ≤1 on question 1b and a 0 on question 1c on the NIH Stroke Scale.
Able to safely participate in protocol-defined walking therapy sessions of 30-minute duration as determined by the Investigator.

Who cannot join

Participant unable or unwilling to provide informed consent.
Has a known history of neurologic (excluding stroke) injury.
Has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions.
Has an external lower limb prosthetic ("artificial limb").
Has a hearing impairment.
Had orthopedic surgery in the last year.
Has co-morbidities that prevent participation in exercise (for example: musculoskeletal, cardiovascular, pulmonary and neurological - other than stroke).
Vulnerable populations as deemed inappropriate for study by site Principal Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

UMass Chan Medical School
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Conditions: Stroke, Acute
Being tested: MR-010
Keywords: rehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MR-010Device
MR-010 includes a patient application and sensors with commercially available headphones and smartphones. Sensors are placed on the subject's shoes and measure gait metrics. The algorithm uses data from the sensors to inform changes made to the audio cues. These cues, which are embedded in time-shifted music, are delivered back to the users who aim to walk to the beat.

Study groups in NCT04689256
Study group	Role	What they receive
MR-010 walking therapy	Experimental	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. Receives: Device: MR-010
Standard of Care	No intervention	Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Gait Speed (m/s)
Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.
Measured: 90 days
Adherence to MR-010 Therapy Schedule
Adherence to the MR-010 therapy schedule is measured by the number of participants who completed scheduled sessions (3 times per week for 12 weeks)
Measured: 90 days

Secondary outcomes (2)

Length of Stay
Median length of stay in acute stroke hospital
Measured: Duration of hospital stay, up to 14 days
Readmission to Hospital
Percent of readmission to hospital following discharge
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202130 Jan 2023

First posted30 Dec 2020
Study start3 Nov 2021
Primary completion30 Jan 2023
Study completion30 Jan 2023

Why it stopped: Study terminated due to lower than expected recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04689256
Sponsor's protocol ID: H00021940
Status last verified: Dec 2024
First submitted: 28 Dec 2020
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
ClinicalTrials.gov ID: NCT04689256
Acronym / sponsor ID: H00021940
Conditions: Stroke, Acute
Keywords: rehabilitation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to lower than expected recruitment
Enrolment: 4 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: MedRhythms, Inc.
Study start: 3 Nov 2021 (actual)
Primary completion: 30 Jan 2023 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 30 Dec 2020 (actual)
Results: Posted 8 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MR-010 walking therapy	Experimental	Device: MR-010Subjects 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.
Standard of Care	No intervention	–Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Must be 18 years of age or older.
Must be able to read and speak English fluently.
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).
Demonstrates some level of asymmetry in gait.

Key exclusion criteria (8 listed)

Participant unable or unwilling to provide informed consent.
Has a known history of neurologic (excluding stroke) injury.
Has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions.
Has an external lower limb prosthetic ("artificial limb").
Has a hearing impairment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MR-010MR-010 includes a patient application and sensors with commercially available headphones and smartphones. Sensors are placed on the subject's shoes and measure gait metrics. The algorithm uses data from the sensors to inform changes made to the audio cues. These cues, which are embedded in time-shifted music, are delivered back to the users who aim to walk to the beat.	Device	MR-010 walking therapy

Primary outcome

Change in Gait Speed (m/s)
Time frame: 90 days
Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.
Adherence to MR-010 Therapy Schedule
Time frame: 90 days
Adherence to the MR-010 therapy schedule is measured by the number of participants who completed scheduled sessions (3 times per week for 12 weeks)

2 secondary outcomes

Length of Stay
Time frame: Duration of hospital stay, up to 14 days
Readmission to Hospital
Time frame: 90 days

Results and safety

Results posted to the registry on 8 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MR-010 Walking Therapy	2	0
Standard of Care	2	2

Primary outcome: Change in Gait Speed (m/s)

Time frame: 90 days

Population analysed: No subjects completed the at home 6 Meter Walking Test. Therefore, no data was collected for this outcome measure.

Primary outcome: Adherence to MR-010 Therapy Schedule

Time frame: 90 days

Population analysed: Data for this outcome was only intended to be collected and measured for participants in the MR-010 walking therapy group. As no participants completed the MR-101 walking therapy intervention, no data was collected.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MR-010 Walking Therapy	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Standard of Care	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): In this study, the intervention group opted not to use the devices or participate in interventions or self-measured data as outlined in the protocol. Further, the study was closed early due to slow enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Silver, MD principal investigator

UMass Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MR-010 in people with Stroke, Acute, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gait Speed (m/s) (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04689256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.