Post-Stroke Walking Speed and Community Ambulation Conversion Study

Study Overview
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Brief Summary
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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 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
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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.

Official Title
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Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study

Conditions
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Chronic Stroke

Intervention / Treatment
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* Device: MR-001
* Other: Active Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years of age and older Equal to or greater than six months post-stroke A comfortable walking speed greater or equal to 0.5 meters per second (m/s), but less than 0.8m/s, as determined by a 10-meter walk test. Demonstrates some level of asymmetry in gait Exclusion Criteria: Has a known history of neurologic (excluding stroke) injury 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 Had orthopedic surgery in the last year Has severe aphasia and/or a speech/language disorder Has co-morbidities that prevent participation in exercise

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br>Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device. | Device: MR-001<br>* 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.<br>* Other names: Digital Rhythmic Auditory Stimulation Delivering Device;|
| Active Comparator: Active Walking Control<br>Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors. | Other: Active Walking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Gait Speed measured by the 10-Meter Walk Test | Mean change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups. | Baseline through study completion, an average of six weeks | 
| Mean Percent Change in Gait Speed measured by the 10-Meter Walk Test | Mean percent change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups. | Baseline through study completion, an average of six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Community Ambulation Status measured by the 10-Meter Walk Test | Gait speed (meters per second) measured by the 10-Meter Walk Test is equal to or greater than 0.8m/s. | At study completion, an average of six weeks | 
| Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system | Cadence as measured by a validated, instrumented walkway system. | Baseline through study completion, an average of six weeks | 
| Change in Stride Length (meters) as measured by a validated, instrumented walkway system | Stride Length as measured by a validated, instrumented walkway system. | Baseline through study completion, an average of six weeks | 
| Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system | Temporal Symmetry as measured by a validated, instrumented walkway system. | Baseline through study completion, an average of six weeks | 
| Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system | Spatial Symmetry as measured by a validated, instrumented walkway system. | Baseline through study completion, an average of six weeks | 
| Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL) | Change in quality of life as measured by the Stroke-Specific Quality of Life scale. Study participants must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains and subscales which include: Energy, Upper extremity function, Work/Productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking and Personality. Patients must respond to each item using the corresponding response set as indicated on 5 point scale. Higher scores indicate better functioning. The SS-QOL yields both domain scores and an overall SS-QOL summary score. The domain scores are unweighted averages of the associated items while the summary score is an unweighted average of all twelve domain scores. | Baseline through study completion, an average of six weeks | 
| Change in 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. The scale includes 59 items and assesses 8 domains: Strength, Hand function, ADL/IADL, Mobility, Communication, Emotion, Memory and thinking, Participation/Role function. Each item is rated using a 5- point Likert scale in terms of the difficulty the patient has experienced in completing each item. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery). | Baseline through study completion, an average of six weeks |