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Study terminated due to lower than expected recruitment
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| Name | Class |
|---|---|
| MedRhythms, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-010 walking therapy | Experimental | 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. |
|
| Standard of Care | No Intervention | Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-010 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Speed (m/s) | Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test. | 90 days |
| Adherence to MR-010 Therapy Schedule | Adherence to the MR-010 therapy schedule is measured by the number of participants who completed scheduled sessions (3 times per week for 12 weeks) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Median length of stay in acute stroke hospital | Duration of hospital stay, up to 14 days |
| Readmission to Hospital | Percent of readmission to hospital following discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Silver, MD | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | United States |
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Patients included following diagnosis of acute stroke
Recruited in hospital after confirmed diagnosis of acute stroke from 11/03/2021 to 11/27/2022. Study terminated due to lower than expected recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | MR-010 Walking Therapy | 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. MR-010: 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. |
| FG001 | Standard of Care | Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MR-010 Walking Therapy | 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. MR-010: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Gait Speed (m/s) | Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test. | No subjects completed the at home 6 Meter Walking Test. Therefore, no data was collected for this outcome measure. | Posted | 90 days |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MR-010 Walking Therapy | 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. MR-010: 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. |
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In this study, the intervention group opted not to use the devices or participate in interventions or self-measured data as outlined in the protocol. Further, the study was closed early due to slow enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Silver | UMass Chan Medical School/UMass Memorial Health | 508-334-5989 | Brian.Silver@umassmemorial.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2021 | Nov 6, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 90 days |
| BG001 | Standard of Care | Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days |
|
| Primary | Adherence to MR-010 Therapy Schedule | Adherence to the MR-010 therapy schedule is measured by the number of participants who completed scheduled sessions (3 times per week for 12 weeks) | Data for this outcome was only intended to be collected and measured for participants in the MR-010 walking therapy group. As no participants completed the MR-101 walking therapy intervention, no data was collected. | Posted | 90 days |
|
|
| Secondary | Length of Stay | Median length of stay in acute stroke hospital | Posted | Median | Full Range | days | Duration of hospital stay, up to 14 days |
|
|
|
| Secondary | Readmission to Hospital | Percent of readmission to hospital following discharge | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Standard of Care | Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days | 0 | 2 | 0 | 2 | 0 | 2 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |