Post-Stroke Walking Speed and Community Ambulation Conversion Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2022-02-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Device

Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using the investigational device.

Group Type EXPERIMENTAL

MR-001

Intervention Type 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.

Active Walking Control

Will walk for 30 minutes at a time, 3 times a week, for 5 weeks using only foot sensors.

Group Type ACTIVE_COMPARATOR

Active Walking

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Digital Rhythmic Auditory Stimulation Delivering Device

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No