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Completed

NCT Number: NCT04121754

Post-Stroke Walking Speed and Community Ambulation Conversion 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.

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Key information

Conditions

Chronic Stroke

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Digital Rhythmic Auditory Stimulation Delivering 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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Community Ambulation Status measured by the 10-Meter Walk Test

    Time frame: 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.

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

    Time frame: Baseline through study completion, an average of six weeks

    Cadence as measured by a validated, instrumented walkway system.

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

    Time frame: Baseline through study completion, an average of six weeks

    Stride Length as measured by a validated, instrumented walkway system.

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

    Time frame: Baseline through study completion, an average of six weeks

    Temporal Symmetry as measured by a validated, instrumented walkway system.

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

    Time frame: Baseline through study completion, an average of six weeks

    Spatial Symmetry as measured by a validated, instrumented walkway system.

  6. Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL)

    Time frame: 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.

  7. Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

MedRhythms, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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