Trial Outcomes & Findings for Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke (NCT NCT04689256)
NCT ID: NCT04689256
Last Updated: 2025-01-08
Results Overview
Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
90 days
Results posted on
2025-01-08
Participant Flow
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
Patients included following diagnosis of acute stroke
Participant milestones
| Measure |
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.
|
Standard of Care
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Standard of Care
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
|
|---|---|---|
|
Overall Study
Participants declined to participate in the interventions per protocol
|
2
|
0
|
Baseline Characteristics
Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Baseline characteristics by cohort
| Measure |
MR-010 Walking Therapy
n=2 Participants
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.
|
Standard of Care
n=2 Participants
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
66.5 years
n=99 Participants
|
67.5 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: No subjects completed the at home 6 Meter Walking Test. Therefore, no data was collected for this outcome measure.
Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 daysPopulation: 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.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of hospital stay, up to 14 daysMedian length of stay in acute stroke hospital
Outcome measures
| Measure |
MR-010 Walking Therapy
n=2 Participants
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.
|
Standard of Care
n=2 Participants
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
|
|---|---|---|
|
Length of Stay
|
3 days
Interval 2.0 to 4.0
|
3 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 90 daysPercent of readmission to hospital following discharge
Outcome measures
| Measure |
MR-010 Walking Therapy
n=2 Participants
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.
|
Standard of Care
n=2 Participants
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
|
|---|---|---|
|
Readmission to Hospital
|
0 Participants
|
0 Participants
|
Adverse Events
MR-010 Walking Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian Silver
UMass Chan Medical School/UMass Memorial Health
Phone: 508-334-5989
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place