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

NCT ID: NCT04689256

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2023-01-30

Brief 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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MR-010

Intervention Type: 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.

Standard of Care

Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedRhythms, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Silver, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

UMass Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

H00021940

Identifier Type: -

Identifier Source: org_study_id