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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device | Experimental | Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device. |
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| Active Walking Control | Active Comparator | Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-001 | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Awad, PT, DPT, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States | ||
| Johns Hopkins University School of Medicine |
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| Active Walking | Other | 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. |
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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 |
| Baltimore |
| Maryland |
| 21218 |
| United States |
| Trustees of Boston University | Boston | Massachusetts | 02215 | United States |
| Spaulding Rehabilitation Hospital | Charlestown | Massachusetts | 02129 | United States |
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Atrium Health/Carolinas Rehabilitation | Charlotte | North Carolina | 28203 | United States |