Clinical trial NCT04121754: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: MedRhythms, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 87
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Gait Speed measured by the 10-Meter Walk Test
timeFrame: Baseline through study completion, an average of six weeks
measure: Mean Percent Change in Gait Speed measured by the 10-Meter Walk Test
timeFrame: Baseline through study completion, an average of six weeks
Secondary outcomes:
measure: Community Ambulation Status measured by the 10-Meter Walk Test
timeFrame: At study completion, an average of six weeks
measure: Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system
timeFrame: Baseline through study completion, an average of six weeks
measure: Change in Stride Length (meters) as measured by a validated, instrumented walkway system
timeFrame: Baseline through study completion, an average of six weeks
measure: Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system
timeFrame: Baseline through study completion, an average of six weeks
measure: Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system
timeFrame: Baseline through study completion, an average of six weeks
measure: Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL)
timeFrame: Baseline through study completion, an average of six weeks
measure: Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0
timeFrame: Baseline through study completion, an average of six weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Trustees of Boston University
state: Massachusetts
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health/Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: Boston University
name: Louis Awad, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: