Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Phase: NA
Conditions: Stroke, Acute
Sponsor: University of Massachusetts, Worcester

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University of Massachusetts, Worcester 
 
 
 
 
 
 
 
H00021940 
MedRhythms' MR-010  
 
 
 
 
 
 
                     [Version 1.0-17JUL2021] 
 
 
 
 
 
 
 
 
 
University of Massachusetts Medical School/ 
UMass Memorial Health 
Pilot Randomized Controlled Study of the Impact of 
MedRhythms' MR-010 in Acute Stroke 
 
 
Protocol Number: Version 1.0 
 
 
 
Name of Investigational Product: 
 
 
MedRhythms' MR-010  
Indication: 
 
 
 
 
 
Acute Ischemic Stroke  
Sponsor: 
 
 
 
 
 
UMass Memorial Healthcare 
 
 
 
 
 
 
 
55 Lake Avenue North 
 
 
 
 
 
 
 
Worcester, MA 01655 
 
 
 
 
 
 
 
Tel: 508-334-5989 
 
Principal Investigator:  
 
 
 
Brian Silver, MD 
Protocol Version: 
 
 
 
 
1.0 
Protocol Date:  
 
 
 
 
Version 1.0 17 July 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 

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H00021940: Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke 
 
Clinical Protocol 
Element 
Description 
Table of Contents 
Protocol Number/Title…………………………………………………………………………………………..……..…1 
Device Risk……………………………………………………………………………………………………………….……..1 
Device Manufacturer…………………………………………………………………………………………………….…1 
IRB…………………………………………………………………………………………………………………………………..1 
Investigational Device Description…………………………………………………………………………………..2 
Enrollment and Consent………………………………………………………………………………………………….2 
Study Objectives…………………………………………………………………………………………………………..…2 
Study Design…………………………………………………………………………………………………………………...2 
Primary Endpoint…………………………………………………………………………………………………………….3 
Secondary Endpoint………………………………………………………………………………………………………..3 
Participant Population…………………………………………………………………………………………………….3 
Inclusion Criteria…………………………………………………………………………………………………………....3 
Exclusion Criteria…………………………………………………………………………………………………………….4 
Procedures……………………………………………………………………………………………………………………..4 
Minimizing Bias………………………………………………………………………………………………………………5 
Study Visits…………………………………………………………………………………………………………………….5 
Study Duration……………………………………………………………………………………………………………….5 
Study Discontinuation………………………………………………………………………………………………..….6 
Benefits/Risks……………………………………………………………………………………………………………..…6 
Data Analysis………………………………………………………………………………………………………………….7 
Confidentiality………………………………………………………………………………………………………..……..8 
Compliance……………………………………………………………………………………………………………..……..8 
Protocol Number / 
Title 
H00021940:  Randomized Controlled Study of the Impact of MedRhythms’ MR-Stride Plus In 
Acute Stroke  
Device Risk 
The investigational device does not meet the criteria of significant risk device as defined in 21 
CFR 812.3(m), because the intended use and technological basis for Stride Plus does not meet 
the following criteria (paraphrased):  
1. intended as an implant  
2. purported or represented for use in supporting or sustaining human life  
3. is for use of substantial importance in diagnosing, curing, mitigating, or treating 
disease or otherwise preventing impairment of human health, or  
4. otherwise represents a potential for serious risk to health, safety or welfare of the 
Participant.  
Device 
Manufacturer  
MedRhythms, Inc.  
183 Middle Street, Suite 300 
Portland, ME 04101 

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Institutional 
Review Board 
The applicable Institutional Review Board (IRB) will review and approve the study protocol 
and informed consent documents prior to enrolling Study Participants into this study 
Investigational 
Device Description 
Device Name:  MedRhythm’s MR-Stride Plus  
 
The following materials will be provided: 
1. Access to Stride Plus patient application.  
2. Mobile Devices. 
3. Motion Sensors.  
4. Headphones. 
 
The MedRhythms  MR-Stride Plus includes a patient application and sensors with 
commercially available headphones and smartphones. The MR-Stride Plus is a device 
intended to improve gait metrics and improve walking speed. This technology uses 
embedded audio cues to facilitate improvements in walking speed based on Rhythmic 
Auditory Stimulation. When using the system, patients walk with sensors that are attached to 
their shoes and collect gait parameters, including the following measurements: speed, stride 
length, symmetry (temporal and spatial), and cadence. 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.  
 
Research shows that walking to an external rhythmic stimulus globally engages the brain, 
coupling the auditory and motor regions. For stroke survivors with damage to the motor 
system, this dual engagement has the effect of establishing new neural connections to the 
motor region. Furthermore, this has the potential to make walking certain distances, which 
may ordinarily be onerous or impossible tasks, achievable for these individuals. As a result of 
neuroplasticity, repeating these audio-cueing exercises on a consistent basis can change 
one’s brain composition, allowing walking improvements made with the device to manifest 
without the engagement of the intervention. 
Enrollment and 
Consent 
Study Participants will be enrolled into the study by a study staff member at participating 
study sites. Once informed consent is received, Study Participants will be screened for 
enrollment into the study.   
Study Objectives 
 
 
The purpose of this clinical study is to evaluate the effects of the Stride-Plus on tolerability, 
biomechanics and  walking speed in the acute stroke care setting in addition to its impact on 
length of stay.  The study will also look at the impacts of the intervention on falls and cost of 
care over a 90-day period post-discharge from acute care setting.  
Study Design 
This study will be a single site, prospective, randomized controlled clinical study. 
Approximately 40 individuals will be enrolled per the inclusion/exclusion criteria.  Participants 
will be randomized using simple randomization into one of two arms. It is expected that 
study participants will be approximately equally distributed to either arm (20/20). 
 
All interested, potential study participants will participate in the screening study phase. A 
member of the study team will seek informed consent and review inclusion and exclusion 
criteria to determine eligibility.  
 
Individuals who qualify for enrollment will be randomized into one of two arms:  
 
 
 
Arm A: Standard of Care + MR-Stride Plus Intervention  
Arm B: Standard of Care  
 

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For all Study Participants, standard of care will be followed in both the acute care setting and 
in the discharge setting. Data required to evaluate the study objectives will be collected from 
record review and participant interviews. Participants will not be required to physically visit 
the study facility for study-specific procedures once they have been discharged from the 
acute care setting. Participants will be contacted by telephone to answer study assessment 
questions (e.g., mRS) intended at Days 45 (+/-2 Days), and 90 (+/-7 Days).   
 
For those Study Participants enrolled into Arm A, study staff will review the intended walking 
intervention therapy schedule with the study participant. The Stride Plus is intended to be 
used for thirty (30) minutes a day, three (3) times a week. Participants will complete the 
following intervention phases related to use of the Stride Plus:   
 
Intervention Phase 1 (within 24 hours from admission): In addition to standard of care 
therapy, study participants will complete at least one (1) walking therapy session with the 
Stride Plus while an inpatient in the acute care setting. Additional study therapy sessions will 
continue until the Study Participant is discharged from the acute care setting.  
 
Intervention Phase 2 (Day 1 post-discharge to Day 90): In addition to standard of care 
therapy, study participants will complete a series of three (3) remote walking therapy 
sessions a week with the Stride Plus following discharge from acute care setting.  Participants 
will schedule their sessions according to their preference and needs. Intervention Phase 2 will 
continue until the Study Participant is 90 days since discharge or earlier if the study 
participant is withdrawn from the study therapy. Participants will complete a walking test 
using the Stride Plus at discontinuation to determine the walking speed.  
 
Post-Intervention Phase: Participants will be followed from discontinuation of the Stride Plus 
until Day 90. At Day 90 (+7 days), participants will complete a walking test using the Stride 
Plus to determine walking speed.  
 
For those study participants in Arm B, the control group, only standard of care therapy will be 
provided. Participants will complete a 6-meter walk test (approximately 20 feet) to measure 
gait speed at baseline, biweekly post- discharge from acute care to day 90 (+/-7 days) 
following discharge.  
 
Primary Endpoint 
The primary study objectives are as follow:    
1) Change in gait speed (m/s) from baseline to study completion (90 days following 
discharge from acute care or earlier if study participant withdraws); 
2) time-to-functional change in gait speed from baseline to study completion 
3) adherence to the MR-Stride Plus therapy schedule.  
Secondary 
Endpoint 
The secondary study objective is to assess the median length of stay in acute stroke hospital 
and the percent of readmission during the 90 (+/-7) days following discharge. 
Participant 
Population 
No age, race, education or geographical restrictions apply. All individuals who meet the 
inclusion/exclusion criteria at participating study sites will be considered. 
Inclusion Criteria 
To be enrolled and randomized into the study, potential Study Participants must meet all of 
the following inclusion criteria:  
1.0 Must be 18 years of age or older.  
2.0 Must be able to read and speak English fluently.  
3.0 Be within 24 hours from admission for confirmed stroke event.  

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4.0 Currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as 
determined by a 6-meter walk test (approximately 20 feet) for comfortable walking 
speed (the average of three trials).  
5.0 Demonstrates some level of asymmetry in gait. 
6.0 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.   
7.0 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.  
8.0 Score ≤1 on question 1b and a 0 on question 1c on the NIH Stroke Scale.  
9.0 Able to safely participate in protocol-defined walking therapy sessions of 30-minute 
duration as determined by the Investigator.   
 
Exclusion Criteria 
In addition, any Study Participant that meets the following criteria will be excluded from 
study enrollment. 
1.0 Participant unable or unwilling to provide informed consent. 
2.0 Has a known history of neurologic (excluding stroke) injury. 
3.0 Has severe aphasia and/or a speech/language disorder, limiting ability to express needs 
and comprehend instructions. 
4.0 Has an external lower limb prosthetic (“artificial limb”). 
5.0 Has a hearing impairment. 
6.0 Had orthopedic surgery in the last year. 
7.0 Has co-morbidities that prevent participation in exercise (for example: musculoskeletal, 
cardiovascular, pulmonary and neurological – other than stroke). 
8.0 Vulnerable populations as deemed inappropriate for study by site Principal Investigator. 
Procedures 
 
 
ARM A: STANDARD OF CARE + MR-STRIDE PLUS 
For Study Participants randomized into Arm A, therapy sessions will begin within twenty-four 
(24) hours of enrollment. Intervention Phase 1 of the study requires a minimum of one (1) 
therapy session with the possibility of additional sessions until discharge; however, no more 
than 3 therapy sessions should occur during a given week. Intervention Phase 2 of the study 
requires 3 independent, remote therapy sessions a week regardless of discharge setting (e.g., 
rehabilitation hospital or home). Therapy will continue until day 90 (+/-7) following discharge 
from acute care. Therapy sessions with the MR-Stride Plus should not replace standard of 
care physical therapy, but be used in addition to standard of care physical therapy. 
Participants may be contacted by the study staff to collect data on the number of standard of 
care physical therapy services provided and occurrence of readmission to acute care.   
 
Participants will be able to schedule their three (3) sessions a week therapy according to 
their needs. Participants will be allowed to miss sessions if they are unable to make them up 
on a different day in the week. Participants therapy activity will be monitored remotely by 
the study team. If participants are unable to maintain the therapy schedule, the study will 
contact the participants to gauge willingness to continue.  At investigator discretion and 
participant agreement, the number of sessions a week  may be reduced  or the participant 
may withdraw from therapy. If the participant is withdrawn from therapy,  participants will 
be asked if they are willing to participate in a gait speed assessment using the MR-Stride Plus 
at day 45 and 90 post-discharge if they have not already been completed.  
 
The 6-meter walk test (approximately 20 feet) will be conducted to evaluate gait speed at 
screening and biweekly thereafter until study completion. Gait speed will also be assessed at 

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the time of withdrawal from study therapy if withdrawal occurs before Day 90 (+/-7) post 
discharge. 
 
At the initial therapy session, Study Participants will be provided with all necessary 
equipment (pre set-up) and instruction for using the MR-Stride Plus. Study staff will provide 
appropriate oversight of the Participant during their initial walking therapy session in acute 
care to ensure safety; study staff will not be required to provide any instruction on use of the 
device.  Participants will conduct 30 minutes of walking therapy at the participant’s self-
selected pace in a space (e.g., track or hallway) that limits the amount of stops and/or pivot 
turns in order to optimize velocity. Participants may choose to take breaks as needed, or 
when investigators believe that a rest break is necessary. The use of an overhead harness 
system is prohibited in this study. If technical or medical issues arise, the training session 
should be terminated to allow for adequate resolution.  
 
For independent, remote therapy sessions following discharge from the acute care hospital, it 
is not required that a participant be under the supervision of clinical staff or a caregiver 
(depending on discharge setting), but participants may choose to according to their 
preference. Participants should perform their therapy sessions in an environment that limits 
safety hazards and, in a space, e.g., track or hallway, that limits the amount of stops and/or 
pivot turns in order to optimize velocity.  Participants will perform their 30 minutes of 
walking therapy at their self-selected pace. 
 
MR-Stride Plus Procedure: Study staff and participants will be required to follow the 
Instructions For Use (IFU) provided by MedRhythms. The IFU will detail all procedures 
required for proper operation of the system. Study Participants will be trained in utilizing the 
Stride Plus by the study staff. Mobile devices that have the MedRhythms Stride Plus 
application installed will be provided for use during therapy sessions. Participants will be 
provided with a pre-established username and password. No personally identifiable patient 
information will be recorded or stored in the Stride Plus application. 
 
ARM B: STANDARD OF CARE 
For Study Participants randomized into Arm B, clinical standard of care will be followed with 
no intervention provided using the MR-Stride Plus.   Participants will also complete the 
6MWT at screening, baseline and biweekly post-discharge from acute care and at days 45 and 
90 (+/-7 days) following discharge.  
 
All participants will be followed for 90 days following discharge from acute care facility for 
initial stroke event and discharge date, discharge setting, number of physical therapy services 
and occurrence of readmission to acute care will be collected.  
 
Minimizing Bias 
The study is not blinded because the primary outcome measure of gait speed renders the 
likelihood of a placebo benefit unlikely. However, Study Participants will be blinded to the 
results of the 6-meter walk test (approximately 20 feet). No results will be provided to the 
Study Participant at any time during participation in the trial.  
Study Visits 
All key assessments will be conducted at the study site and remotely via telecommunication, 
as applicable. 
Study Duration 
Each Participant is required to complete a screening visit. For Participants who are 
randomized into Arm A (MR-Stride Plus Intervention), therapy sessions will take 
approximately forty-five (45) minutes for set-up and therapy. After the first therapy session in 

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the acute care setting, participants should be able to complete the setup and therapy session 
with the MR-Stride Plus independently.  Collection of data related to study adherence (for 
participants in the MR-Stride Plus Intervention), gait speed assessment,  standard of care 
administration, discharge and readmission will be performed by study staff remotely through 
review of medical records, MR-Stride Plus database, and by contacting the participant over 
the phone. Once participants have reached 90 days following discharge from the acute care 
facility for the initial stroke event, no follow-up or subsequent Participant involvement is 
required. 
Study 
Discontinuation, 
Drop Out, 
Withdrawal and 
Replacement 
Participants may discontinue their participation in the study at any time. A Participant may be 
withdrawn from the study at any time at the discretion of the Investigator. 
 
Participants who are withdrawn or drop out prior to the study endpoint will still have data 
that was collected up until the withdrawal/drop out eligible for analysis. These Participants 
will be analyzed in an Intent-To-Treat analysis. 
Benefits / Risks 
Benefits 
This project will facilitate the development and clinical translation of targeted gait 
interventions that can improve walking ability, including the development of new technology 
that extends the abilities of clinicians. 
  
Risks  
There are some risks to participating in this study. We have categorized them below as Possible, 
Less Likely, and Rare risks. In summary, the expected risks include: 
 
Possible risks: 
• 
Fatigue 
• 
Nausea 
• 
Shortness of breath 
• 
Muscle or joint soreness 
• 
Minor muscle cramps  
• 
Loss of balance or fall  
 
Fatigue; Muscle or joint soreness – Depending on participants’ level of disability, sessions will 
be mildly to moderately strenuous. The participant may become fatigued, or experience joint 
soreness in their hip, knee, ankle or foot.  
 
Fatigue; Nausea; Shortness of breath; Muscle cramps or muscle soreness – As with any exercise, 
there is the possibility that abnormal responses could occur. These include nausea, shortness 
of breath, fatigue, muscle cramps or soreness (lasting into subsequent days after testing).  
 
Loss of balance or fall: 
There is a risk of falling to the ground. Participants who typically wear an ankle brace may be 
asked to walk without the brace. When walking without the brace, the foot and ankle may not 
be as stable and there is an increased risk of ankle sprains during walking and falling.  
Less Likely Risks: 
• 
Muscle strain/tear 
• 
Injury due to fall (ankle sprain, twisted knee, etc.) 
• 
Abnormal physiological response to physical activity  
• 
Irregular heart rate 
• 
Fainting 
• 
Bruising and bleeding  

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Muscle strain/tear; Injury due to fall : 
Injuries such as muscle strains and tears are also possible due to exercise activities. Injuries due 
to falling are also possible.  
 
Abnormal physiological response; Irregular heart rate; Fainting: 
As with any exercise, there is the possibility that abnormal responses could occur. These 
abnormal responses include unexpected changes in blood pressure, irregular heart rate, 
fainting, or joint injury. This risk is increased in the post stroke population.  
 
Bruising and bleeding : 
Participants who are taking anticoagulants may be at increased risk for bruising and bleeding 
due to a fall. 
 
Rare Risks:  
• 
Heart problems  
• 
Hospitalization 
• 
Anxiety  
• 
Heart attack 
• 
Stroke 
• 
Death 
 
Heart and lung problems; Hospitalization: 
As with any exercise, there is the possibility that abnormal responses could occur. Rare risks 
associated with exercise could include heart problems or hospitalization and in very rare cases, 
stroke and death. There is also a risk of pulmonary embolism.  
 
Anxiety : 
There also is a potential risk for Study Participants to become anxious.  
 
Many of the investigators are licensed physical therapists and most study staff and students 
have training in CPR and first aid. All of the aforementioned risks will also be mitigated through 
the following: 
• 
Potential Study Participants will be provided with the consent form and be provided ample 
time to read it and ask questions. The research team will address any concerns. Study 
Participants will be told that participation in the study is completely voluntary and they 
have the right to withdraw from the study at any time. 
• 
Adequate rest periods and water will be encouraged to optimize comfort and reduce 
fatigue. 
• 
Total walking time per therapy session will be limited to one half hour. 
• 
Trained investigators may monitor vital signs and check for symptoms of distress during 
the initial therapy session with the MR-Stride Plus. Any findings out of the ordinary will be 
reported to the participant’s primary healthcare provider or emergency services should 
they require medical attention. 
 
All participants are free to end testing or procedures that cause anxiety or discomfort at any 
time, this will not affect any remuneration or transportation they are entitled to. 
Data Analysis 
UMass Memorial Health Care will be responsible for data analysis. 
Intent to treat: All Study Participants that enrolled in the study, regardless of withdrawal or 
incomplete data (if analysis can be made) 

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Confidentiality 
The Principal Investigator and designees, employees, and agents involved with this study will 
comply with relevant state and federal laws relating to the confidentiality, privacy and 
security of Participant’s health information.  They will only create, maintain, use or disclose 
any data that is generated by this study or other information disclosed to the Principal 
Investigator or their employees or agents during the course of the study to MedRhythms, 
Institutional Review Board, Regulatory Authority or other authorized recipients as 
appropriate for the execution, analysis, review and reporting of this study.  Such information 
shall not be used for any other purposes and will remain confidential.   
  
Study Participants will be informed that all data collected for study purposes will be held in 
strict confidence and used for research purposes only. Records may be paper or electronic. 
Privacy of participants will be protected by conducting all in-person interactions in a semi-
private or private space within the rehabilitation laboratories. No personally identifiable 
information will be discussed in common areas. 
 
Paper Documents 
Will be stored in a locked file cabinet that only the study staff has access to. Study Participant 
files may also be scanned and stored on a secure, password-protected server authorized to 
store restricted data, with access provided only to the PI and key study staff.  
 
Codified Study Participant Identification Number  
Data collected during this research will be labeled using a codified participant identification 
number.  
 
Research Data  
Data collected specifically for the study will be labeled with the applicable Study Participant 
ID and stored on a secure, password-protected server. Data may be transferred as a local 
copy to password-protected study staff computers for processing or to prepare media 
material for publications, presentations or training purposes. 
 
System Data  
The MR-Stride Plus device will collect and store data related to the platform’s performance 
on a secured cloud-based drive owned by MedRhythm’s. Personally identifiable information 
will not be collected by the platform or stored by the company. Only the PI and designated 
study staff will have access to the data collected under this protocol. The PI and all study staff 
will have access to all coded data housed on a password-protected secured network drive.  
Compliance  
Changes or amendments to the protocol will be submitted to the institutional review board 
(IRB), as required. Subsequently, Study Participants will be notified of protocol changes that 
may affect their participation in the study. Further participation may be contingent upon re-
signing an Informed Consent form. 
 
Protocol deviations will be collected and described in the final report. 
 
Occurrences of adverse events will be described and recorded and any medical attention 
sought will be documented. If a deviation in data collection/usage, adverse or unanticipated 
event involving risks to participants or others, or a breach in confidentiality is suspected or 
found, the study will be halted until a resolution is determined in accordance with the 
Institutional Review Board.