Back to resultsPost-Stroke Walking Speed and Community Ambulation Conversion Study
Primary Purpose
Chronic Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR-001
Active Walking
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke
Eligibility Criteria
Inclusion Criteria: 50 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 Exclusion Criteria: 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
Sites / Locations
- Shirley Ryan AbilityLab
- Johns Hopkins University School of Medicine
- Trustees of Boston University
- Spaulding Rehabilitation Hospital
- Kessler Foundation
- Icahn School of Medicine at Mount Sinai
- University of North Carolina at Chapel Hill
- Atrium Health/Carolinas Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational Device
Active Walking Control
Arm Description
Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device.
Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system
Cadence as measured by a validated, instrumented walkway system.
Change in Stride Length (meters) as measured by a validated, instrumented walkway system
Stride Length as measured by a validated, instrumented walkway system.
Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system
Temporal Symmetry as measured by a validated, instrumented walkway system.
Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system
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)
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04121754
Brief Title
Post-Stroke Walking Speed and Community Ambulation Conversion Study
Official Title
Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedRhythms, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Device
Arm Type
Experimental
Arm Description
Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device.
Arm Title
Active Walking Control
Arm Type
Active Comparator
Arm Description
Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors.
Intervention Type
Device
Intervention Name(s)
MR-001
Other Intervention Name(s)
Digital Rhythmic Auditory Stimulation Delivering Device
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change in Gait Speed measured by the 10-Meter Walk Test
Description
Mean change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.
Time Frame
Baseline through study completion, an average of six weeks
Title
Mean Percent Change in Gait Speed measured by the 10-Meter Walk Test
Description
Mean percent change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.
Time Frame
Baseline through study completion, an average of six weeks
Secondary Outcome Measure Information:
Title
Community Ambulation Status measured by the 10-Meter Walk Test
Description
Gait speed (meters per second) measured by the 10-Meter Walk Test is equal to or greater than 0.8m/s.
Time Frame
At study completion, an average of six weeks
Title
Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system
Description
Cadence as measured by a validated, instrumented walkway system.
Time Frame
Baseline through study completion, an average of six weeks
Title
Change in Stride Length (meters) as measured by a validated, instrumented walkway system
Description
Stride Length as measured by a validated, instrumented walkway system.
Time Frame
Baseline through study completion, an average of six weeks
Title
Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system
Description
Temporal Symmetry as measured by a validated, instrumented walkway system.
Time Frame
Baseline through study completion, an average of six weeks
Title
Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system
Description
Spatial Symmetry as measured by a validated, instrumented walkway system.
Time Frame
Baseline through study completion, an average of six weeks
Title
Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL)
Description
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.
Time Frame
Baseline through study completion, an average of six weeks
Title
Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0
Description
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).
Time Frame
Baseline through study completion, an average of six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Awad, PT, DPT, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Trustees of Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Atrium Health/Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Stroke Walking Speed and Community Ambulation Conversion Study
We'll reach out to this number within 24 hrs