Post-Stroke Walking Speed and Community Ambulation Conversion Study

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121754
• Other study ID #: PS100
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: February 11, 2022

Study information

• Verified date: August 2023
• Source: MedRhythms, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Trustees of Boston University	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts
United States	Atrium Health/Carolinas Rehabilitation	Charlotte	North Carolina
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
MedRhythms, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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