Post-Stroke Walking Speed and Community Ambulation Conversion Study

NCT04121754 | Completed FDA Device

• 1 other identifier: PS100
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (2)

• Mean Change in Gait Speed measured by the 10-Meter Walk Test

  Mean change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.

  Baseline through study completion, an average of six weeks

• Mean Percent Change in Gait Speed measured by the 10-Meter Walk Test

  Mean percent change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.

  Baseline through study completion, an average of six weeks

Secondary Outcomes (7)

• Community Ambulation Status measured by the 10-Meter Walk Test

  At study completion, an average of six weeks

• Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system

  Baseline through study completion, an average of six weeks

• Change in Stride Length (meters) as measured by a validated, instrumented walkway system

  Baseline through study completion, an average of six weeks

• Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system

  Baseline through study completion, an average of six weeks

• Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system

  Baseline through study completion, an average of six weeks

Study Arms (2)

Investigational Device

EXPERIMENTAL

Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device.

Device: MR-001

Active Walking Control

ACTIVE COMPARATOR

Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors.

Other: Active Walking

Interventions

MR-001 DEVICE

Participants will walk using the investigational device (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 3 times a week for 5 weeks.

Also known as: Digital Rhythmic Auditory Stimulation Delivering Device

Investigational Device

Active Walking OTHER

Participants will walk for thirty (30) minutes at a time, 3 times a week for 5 weeks. No mobile devices, music players or headphones will be allowed. They will wear foot sensors during their active walking sessions to measure gait biomechanics.

Active Walking Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Equal to or greater than six months post-stroke
• A comfortable walking speed greater or equal to 0.5 meters per second (m/s), but less than 0.8m/s, as determined by a 10-meter walk test.
• Demonstrates some level of asymmetry in gait

You may not qualify if:

• Has a known history of neurologic (excluding stroke) injury
• Has had more than 2 falls in the previous month
• Is enrolled in another walking rehabilitation intervention (e.g., physical therapy)
• Has an external lower limb prosthetic ("artificial limb")
• Has a hearing impairment
• Had orthopedic surgery in the last year
• Has severe aphasia and/or a speech/language disorder
• Has co-morbidities that prevent participation in exercise

Sponsors & Collaborators

• MedRhythms, Inc.: lead

Study Sites (8)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21218, United States

Location

Trustees of Boston University

Boston, Massachusetts, 02215, United States

Location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Atrium Health/Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

Study Officials

• Louis Awad, PT, DPT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: September 17, 2019
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)