Post-Stroke Walking Speed and Community Ambulation Conversion Study

Not Applicable

Completed

• Conditions: Chronic Stroke
• Interventions: Device: MR-001; Other: Active Walking

• Registration Number: NCT04121754
• Lead Sponsor: MedRhythms, Inc.

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.

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 Timeline

• Study Start: 2019-09-17
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Primary Completion: 2022-02-11
• Study Completion: 2022-02-11
• Disposition First Submitted: 2023-01-26
• Disposition First Submitted QC: 2023-01-26
• Disposition First Posted: 2023-01-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Device	MR-001	Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device.
Active Walking Control	Active Walking	Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors.

Primary Outcome Measures

Name	Time	Method
Mean Change in Gait Speed measured by the 10-Meter Walk Test	Baseline through study completion, an average of six weeks	Mean change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.
Mean Percent Change in Gait Speed measured by the 10-Meter Walk Test	Baseline through study completion, an average of six weeks	Mean percent change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.

Secondary Outcome Measures

Name	Time	Method
Community Ambulation Status measured by the 10-Meter Walk Test	At study completion, an average of six weeks	Gait speed (meters per second) measured by the 10-Meter Walk Test is equal to or greater than 0.8m/s.
Change in Stride Length (meters) as measured by a validated, instrumented walkway system	Baseline through study completion, an average of six weeks	Stride Length as measured by a validated, instrumented walkway system.
Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system	Baseline through study completion, an average of six weeks	Cadence as measured by a validated, instrumented walkway system.
Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0	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. 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).
Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system	Baseline through study completion, an average of six weeks	Temporal Symmetry as measured by a validated, instrumented walkway system.
Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system	Baseline through study completion, an average of six weeks	Spatial Symmetry as measured by a validated, instrumented walkway system.
Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL)	Baseline through study completion, an average of six weeks	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.

Trial Locations

Locations (8)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Trustees of Boston University; 🇺🇸 Boston, Massachusetts, United States

Spaulding Rehabilitation Hospital; 🇺🇸 Charlestown, Massachusetts, United States

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Atrium Health/Carolinas Rehabilitation; 🇺🇸 Charlotte, North Carolina, United States