Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04689256
Other study ID # H00021940
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05378035 - DOAC in Chinese Patients With Atrial Fibrillation
Completed NCT03679637 - Tablet-based Aphasia Therapy in the Acute Phase After Stroke N/A
Completed NCT03574038 - Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke N/A
Completed NCT03633422 - Evaluation of Stroke Patient Screening
Completed NCT04088578 - VNS-supplemented Motor Retraining After Stroke N/A
Not yet recruiting NCT05534360 - Tenecteplase Treatment in Ischemic Stroke Registry
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Withdrawn NCT05786170 - ERILs Und SNILs Unter SOC N/A
Not yet recruiting NCT04105322 - Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients N/A
Recruiting NCT03132558 - Contrast Induced Acute Kidney in Patients With Acute Stroke N/A
Completed NCT02893631 - Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
Active, not recruiting NCT02274727 - Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
Completed NCT02225730 - Imaging Collaterals in Acute Stroke (iCAS)
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Active, not recruiting NCT01581502 - SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF) N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00761982 - Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment. Phase 1/Phase 2
Completed NCT00535197 - Autologous Bone Marrow Stem Cells in Ischemic Stroke. Phase 1/Phase 2
Terminated NCT00132509 - FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke Phase 2
Recruiting NCT05760326 - Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients