Chronic StrokeNCT04121754
Post-Stroke Walking Speed and Community Ambulation Conversion Study
A study testing MR-001 and Active Walking in people with Chronic Stroke, run by MedRhythms, Inc. at 8 sites in United States.
Trial 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 or equal to six (6) months in the past and who are limited in… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- MR-001 and Active Walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Sep 2019to 11 Feb 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age and older
- Equal to or greater than six months post-stroke
- A comfortable walking speed greater than or equal to 0.5 m/s but less than 0.8 m/s, as determined by a 10-meter walk test, without assistive devices
- Demonstrates some level of asymmetry in gait
- Able and willing to consent, including to communicate with the treating clinician as needed during the study
- Score ≤ 1 on question 1b and 0 on question 1c of the NIH Stroke Scale
- Able to safely participate in 30-minute walking therapy sessions
Who cannot join
- Currently enrolled in a study evaluating an investigational drug
- Has already participated in this study
- Unable or unwilling to provide informed consent
- Unable to participate in 30-minute walking therapy sessions without assistive devices
- Is a community ambulator (walking speed ≥ 0.8 m/s) without an assistive device
- Has a known history of neurologic (excluding stroke) injury
Show all 15Show fewer
- Has had more than 2 falls in the previous month
- Is enrolled in another walking rehabilitation intervention (e.g., physical therapy)
- Has an external lower limb prosthetic ("artificial limb")
- Has a hearing impairment that prevents interaction with the intervention system
- Had orthopedic surgery in the last year
- Has severe aphasia and/or a speech/language disorder
- Has co-morbidities that prevent participation in exercise
- Is part of a vulnerable population deemed inappropriate for the study by the site Principal Investigator
- Note: Assistive devices include a cane, crutch, walker, or FES device; a lower limb brace is permitted.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21218
Trustees of Boston University
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
Atrium Health/Carolinas Rehabilitation
Charlotte, North Carolina, 28203
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Kessler Foundation
West Orange, New Jersey, 07052
About this study
Official title: Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study
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 or equal to 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.
Read the 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
- Being tested
- MR-001, Active Walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-001Device
Also called Digital Rhythmic Auditory Stimulation Delivering Device, Stride Plus, InTandem
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.
Active WalkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device. Receives: Device: MR-001 |
| Active Walking Control | Active comparator | Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors. Receives: Other: Active Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Comfortable Walking Speed (m/s)
Comfortable Walking Speed (CWS) is assessed using the 10-Meter Walk Test (10MWT). Participants complete three trials of self-selected comfortable walking speed at baseline and again at the post-intervention closing visit. The average of the three trials at each time point is used.
CWS is calculated as distance walked (10 meters) divided by time in seconds, expressed in meters per second (m/s). Higher scores indicate faster walking speed and better functional mobility.
The outcome is the change from baseline, defined as:
Change in Comfortable Walking Speed = Post-Intervention CWS - Baseline CWS
Measured: Pre- vs Post-Intervention (~5 weeks)
Mean Percent Change in Comfortable Walking Speed (CWS)
Percent Change in Comfortable Walking Speed (CWS) is assessed using the 10-Meter Walk Test (10MWT). Participants complete three trials of self-selected comfortable walking speed at baseline and again at the post-intervention closing visit. The average of the three trials at each time point is used.
Percent change is calculated as:
Percent Change in CWS = [(Post-Intervention CWS - Baseline CWS) / Baseline CWS] × 100
Higher values indicate greater relative improvement in walking speed.
Measured: Pre- vs Post-Intervention (~5 weeks)
Secondary outcomes (8)
Community Ambulation Status (Proportion Achieving Walking Speed ≥ 0.8 m/s)
Community ambulation status is determined using the 10-Meter Walk Test (10MWT). Participants complete three trials of self-selected comfortable walking speed at baseline and at the post-intervention closing visit. The average speed at each time point is used.
Community ambulation is defined as a comfortable walking speed of 0.8 meters per second or greater. The outcome is the proportion of participants in each group who achieved community ambulation status at the closing visit.
Measured: Pre vs Post-Intervention (~5 weeks)
Proportion of Responders (Change Greater Than 0.16 m/s MCID AND Community Ambulation Conversion)
A responder is defined as a participant who both (1) had a change in Comfortable Walking Speed exceeding the 0.16 m/s MCID and (2) achieved community ambulation status, defined as a post-intervention CWS of 0.80 m/s or greater, measured by the 10-Meter Walk Test. The outcome is the proportion of participants in each group meeting both criteria.
Measured: Pre- vs Post-Intervention (~5 weeks)
Change in Cadence (Steps Per Minute)
Cadence is measured using an instrumented walkway system. Participants complete three trials of self-selected comfortable walking at baseline and again at the post-intervention closing visit. The average cadence value at each time point is used. Cadence is reported in steps per minute, with higher values indicating faster stepping frequency.
Measured: Pre vs Post-Intervention (~5 weeks)
Change in Stride Length (Meters)
Stride length is measured using an instrumented walkway system. Participants complete three trials of self-selected comfortable walking at baseline and at the post-intervention closing visit. The average stride length at each time point is used.
Change in stride length is calculated as:
Change in Stride Length = Closing Visit Stride Length - Baseline Stride Length
Positive values indicate an increase in stride length.
Measured: Pre vs Post-Intervention (~5 weeks)
Change in Step Length Symmetry (Spatial Symmetry)
Step length symmetry is a measure of spatial gait symmetry from a validated, instrumented walkway system. Step length is the distance between the heel centers of successive footfalls of opposite feet, along the line of progression. Three trials of self-selected comfortable walking were averaged at baseline and at the post-intervention closing visit.
Calculation - symmetry ratio (SR) = larger average step length / smaller average step length, so the value is always at least 1.0. A ratio of 1.0 is perfect symmetry; a higher ratio means greater asymmetry and a worse outcome.
Reported value = Closing SR - Baseline SR. A negative change (SR moving down toward 1.0) means improved, more symmetric gait and is the better outcome; a positive change means worsening.
Measured: Pre- vs Post-Intervention (~5 weeks)
Change in Double Support (Temporal Symmetry)
Double support temporal symmetry is a measure of temporal gait symmetry from a validated, instrumented walkway system. Double support is the portion of the gait cycle when both feet are in contact with the ground. Three trials of self-selected comfortable walking were averaged at baseline and at the post-intervention closing visit.
Calculation - symmetry ratio (SR) = larger average double-support time / smaller average double-support time, so the value is always at least 1.0. A ratio of 1.0 is perfect symmetry; a higher ratio means greater asymmetry and a worse outcome.
Reported value = Closing SR - Baseline SR. A negative change (SR moving down toward 1.0) means improved, more symmetric gait and is the better outcome; a positive change means worsening.
Measured: Pre vs Post-Intervention (~5 weeks)
Change in Stroke-Specific Quality of Life (SSQoL)
The Stroke-Specific Quality of Life (SSQoL) scale is a patient-reported measure of health-related quality of life over the past week. It has 49 items across 12 domains: energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work/productivity.
Scoring: each item is rated 1 to 5; each domain score is the unweighted average of its items; the total score is the unweighted average of the 12 domain scores. The total score ranges from 1 to 5, with higher scores indicating better quality of life.
The reported value is the change in the total score = Closing Visit total - Baseline total. Positive values indicate improved quality of life.
Measured: Pre vs Post-Intervention (~5 weeks)
Change in Q9 on Self-perceived Disability as Measured by the Stroke Impact Scale (SIS), Version 3.0
Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0. Q9 is the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery).
Measured: Pre vs Post-Intervention (~5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start17 Sep 2019
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
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 Chronic StrokeStudies of the same condition, open and under way.
- 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedRhythms, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Awad, PT, DPT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121754
- Sponsor's protocol ID
- PS100
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2019
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study
- ClinicalTrials.gov ID
- NCT04121754
- Acronym / sponsor ID
- PS100
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- MedRhythms, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 9 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 or equal to 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: MR-001Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device. |
| Active Walking Control | Active comparator | Other: Active WalkingWill walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50 years of age and older
- Equal to or greater than six months post-stroke
- A comfortable walking speed greater than or equal to 0.5 m/s but less than 0.8 m/s, as determined by a 10-meter walk test, without assistive devices
- Demonstrates some level of asymmetry in gait
- Able and willing to consent, including to communicate with the treating clinician as needed during the study
Key exclusion criteria (15 listed)
- Currently enrolled in a study evaluating an investigational drug
- Has already participated in this study
- Unable or unwilling to provide informed consent
- Unable to participate in 30-minute walking therapy sessions without assistive devices
- Is a community ambulator (walking speed ≥ 0.8 m/s) without an assistive device
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-001Also: Digital Rhythmic Auditory Stimulation Delivering Device, Stride Plus, InTandemParticipants 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. | Device | Investigational Device |
| Active WalkingParticipants 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. | Other | Active Walking Control |
Primary outcome
Change in Comfortable Walking Speed (m/s)
Time frame: Pre- vs Post-Intervention (~5 weeks)
Comfortable Walking Speed (CWS) is assessed using the 10-Meter Walk Test (10MWT). Participants complete three trials of self-selected comfortable walking speed at baseline and again at the post-intervention closing visit. The average of the three trials at each time point is used. CWS is calculated as distance walked (10 meters) divided by time in seconds, expressed in meters per second (m/s). Higher scores indicate faster walking speed and better functional mobility. The outcome is the change from baseline, defined as: Change in Comfortable Walking Speed = Post-Intervention CWS - Baseline CWS
Mean Percent Change in Comfortable Walking Speed (CWS)
Time frame: Pre- vs Post-Intervention (~5 weeks)
Percent Change in Comfortable Walking Speed (CWS) is assessed using the 10-Meter Walk Test (10MWT). Participants complete three trials of self-selected comfortable walking speed at baseline and again at the post-intervention closing visit. The average of the three trials at each time point is used. Percent change is calculated as: Percent Change in CWS = [(Post-Intervention CWS - Baseline CWS) / Baseline CWS] × 100 Higher values indicate greater relative improvement in walking speed.
8 secondary outcomes
Community Ambulation Status (Proportion Achieving Walking Speed ≥ 0.8 m/s)
Time frame: Pre vs Post-Intervention (~5 weeks)
Proportion of Responders (Change Greater Than 0.16 m/s MCID AND Community Ambulation Conversion)
Time frame: Pre- vs Post-Intervention (~5 weeks)
Change in Cadence (Steps Per Minute)
Time frame: Pre vs Post-Intervention (~5 weeks)
Change in Stride Length (Meters)
Time frame: Pre vs Post-Intervention (~5 weeks)
Change in Step Length Symmetry (Spatial Symmetry)
Time frame: Pre- vs Post-Intervention (~5 weeks)
Change in Double Support (Temporal Symmetry)
Time frame: Pre vs Post-Intervention (~5 weeks)
Change in Stroke-Specific Quality of Life (SSQoL)
Time frame: Pre vs Post-Intervention (~5 weeks)
Change in Q9 on Self-perceived Disability as Measured by the Stroke Impact Scale (SIS), Version 3.0
Time frame: Pre vs Post-Intervention (~5 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
Louis Awad, PT, DPT, PhD principal investigator
Boston University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-001 and Active Walking in people with Chronic Stroke, run by MedRhythms, Inc. at 8 sites 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 9 Oct 2026). 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 Comfortable Walking Speed (m/s) (time frame: Pre- vs Post-Intervention (~5 weeks)). 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?
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 9 Oct 2026.