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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689256
• Other study ID #: H00021940
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: Brian Silver, MD
• Phone: 508-334-2527
• Email: brian.silver[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	MedRhythms, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed (m/s)	Change in gait speed (m/s) from baseline to study completion	90 days
Primary	Adherence to MR-010 therapy schedule	Percentage of scheduled sessions completed (3 times per week for 12 weeks)	90 days
Secondary	Length of stay	Median length of stay in acute stroke hospital	Duration of hospital stay, average 5 days
Secondary	Readmission to hospital	Percent of readmission to hospital following discharge	90 days