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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Device: MR-010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-010 walking therapy<br>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. | Device: MR-010<br>* 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.<br>|
| No Intervention: Standard of Care<br>Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gait speed (m/s) | Change in gait speed (m/s) from baseline to study completion | 90 days | 
| Adherence to MR-010 therapy schedule | Percentage of scheduled sessions completed (3 times per week for 12 weeks) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Median length of stay in acute stroke hospital | Duration of hospital stay, average 5 days | 
| Readmission to hospital | Percent of readmission to hospital following discharge | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation