Post-Stroke Walking Speed and Community Ambulation Conversion Study

Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Device: MR-001; Other: Active Walking

Detailed Description

Study participants who take part in this research study will participate in a screening visit, fifteen (15) intervention visits over approximately five weeks and a final closing visit. Study participants will be assigned by chance to one of the two study groups. Participants will not be able to switch groups once they are assigned. The investigational device includes a mobile device app and sensors that are attached to shoes. Headphones and a mobile device are also required to be used and will be provided in this study.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Trustees of Boston University
    • Charlestown, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health/Carolinas Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 50 years of age and older
2. Equal to or greater than six months post-stroke
3. 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.
4. Demonstrates some level of asymmetry in gait

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Device; Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device.	Device: MR-001; 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.; Other Names: Digital Rhythmic Auditory Stimulation Delivering Device
Active Comparator: Active Walking Control; Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors.	Other: Active Walking; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community Ambulation Status measured by the 10-Meter Walk Test	Gait speed (meters per second) measured by the 10-Meter Walk Test is equal to or greater than 0.8m/s.	At study completion, an average of six weeks
Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system	Cadence 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	Stride Length 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	Temporal Symmetry 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	Spatial Symmetry as measured by a validated, instrumented walkway system.	Baseline through study completion, an average of six weeks
Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL)	Change in quality of life as measured by the Stroke-Specific Quality of Life scale. Study participants must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains and subscales which include: Energy, Upper extremity function, Work/Productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking and Personality. Patients must respond to each item using the corresponding response set as indicated on 5 point scale. Higher scores indicate better functioning. The SS-QOL yields both domain scores and an overall SS-QOL summary score. The domain scores are unweighted averages of the associated items while the summary score is an unweighted average of all twelve domain scores.	Baseline through study completion, an average of six weeks
Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0	Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0. The scale includes 59 items and assesses 8 domains: Strength, Hand function, ADL/IADL, Mobility, Communication, Emotion, Memory and thinking, Participation/Role function. Each item is rated using a 5- point Likert scale in terms of the difficulty the patient has experienced in completing each item. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery).	Baseline through study completion, an average of six weeks

Collaborators and Investigators

• Sponsor: MedRhythms, Inc.
• Investigators: Principal Investigator: Louis Awad, PT, DPT, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): February 11, 2022
• Study Completion (Actual): February 11, 2022

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PS100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes