To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.
This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
495
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Gait Velocity
Improved ambulation status, specific to increase in gait velocity (m/s)
Time frame: 6 months
Stroke Impact Scale (SIS) Composite Score
The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.
Time frame: 6 months
Device Related Serious Adverse Events
The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).
Time frame: 6 months
Six Minute Walk Test
Time frame: 6 months
Modified Emory Functional Ambulation Profile Total Score
The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up \& Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.
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The Loma Linda University Medical Center
Loma Linda, California, United States
The Los Angeles VA
Los Angeles, California, United States
Casa Colina Centers for Rehabilitation
Pomona, California, United States
The San Francisco VA Medical Center
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Halifax Hospital
Daytona Beach, Florida, United States
Florida Hospital NORI
Orlando, Florida, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Marianjoy Rehabilitation
Wheaton, Illinois, United States
...and 19 more locations
Time frame: 6 months
Modified Emory Functional Ambulation Profile Floor Time
The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.
Time frame: 6 months
Modified Emory Functional Ambulation Profile Carpet Time
The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .
Time frame: 6 months
Modified Emory Functional Ambulation Profile Timed up and Go
The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.
Time frame: 6 months
Modified Emory Functional Ambulation Profile Obstacle Course
The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.
Time frame: 6 months
Modified Emory Functional Ambulation Profile Stair Time
The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .
Time frame: 6 months
Berg Balance Scale
The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.
Time frame: 6 months