WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

Not Applicable

Completed

Conditions: Stroke

Interventions: Other: Ankle-Foot Orthosis (AFO)
Device: WalkAide

Registration Number: NCT01087957

Lead Sponsor: Innovative Neurotronics

Brief Summary: 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.

Detailed Description: This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 495

Inclusion Criteria

Patient history of stroke (ischemic and/or hemorrhagic).
Patient is at least 6 months post stroke.
Patient has hemiplegia/hemiparesis.
Patient has inadequate dorsiflexion during swing phase of gait, resulting in inadequate limb clearance.
Patient is not currently using Functional Electrical Stimulation for the treatment of footdrop.
Patient is a minimum of 30 days post inpatient or outpatient stroke, cardiac, pulmonary, or physical rehabilitation on the lower extremity.
Patient is a minimum of 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement).
Patient is a minimum of 90 days post myocardial infarction.
Patient is a minimum of 90 days post stenting procedure (i.e. peripheral, cardiac, carotid, and/or renal).
Patient is a minimum of 6 months post CABG or cardiac valve procedure.
Patient is able to walk at least 10 meters with or without an assist device (excluding an AFO or WalkAide device).
Patient has an initial gait speed > 0.0 m/s and < 0.8 m/s.
Patient has a positive response to peroneal nerve stimulation testing, resulting adequate dorsiflexion of the ankle.
Patient has adequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score >17 within 30 days prior to enrollment.
Patient has completed a full neurological assessment within 30 days prior to enrollment.
Patient is eligible for Medicare or Medicare Choice/Advantage benefits at the time of enrollment
Patient is able and willing to comply with study procedures, including follow-up requirements.
Patient is able and willing to give written informed consent.

Exclusion Criteria

Patient is less than 6-months post stroke.
Patient has inadequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score < 17 within 30 days prior to enrollment.
Patient has ankle joint instability other than foot drop.
Patient is less than 30 days post inpatient or outpatient: stroke, cardiac, pulmonary, or any type of physical rehabilitation on the lower extremity at time of enrollment.
Patient has need for an AFO for stance control of the foot, ankle and/or knee.
Patient has an initial gait speed of 0.8 m/s or greater classified as a full community walker (independent in all home and community activities).
Patient is not able to safely clear toes in swing phase on the involved lower extremity, defined as >-5° plantar flexion, with the device determined at fitting visit.
Patient has been diagnosed with peripheral neuropathy and symptoms obstruct or limit ambulation or participation in study procedures.
Patient has been diagnosed with significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication.
Patient has underlying condition(s) that would limit study participation such as severe hypertonicity resulting in the need for more involved orthotic strategies or excessive dysesthetic pain secondary to neurological involvement.
Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Patient is NYHA Class III or IV.
Patient has malignant skin lesion below the knee on the affected lower extremity.
Patient has history of seizure disorder and on seizure medications.
Patient has aphasia, defined as incapacity to verbalize commands.
Patient has Beck Depression Index score of > 29 indicating severe depression.
Patient has a life expectancy less than 12 months.
Patient has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation, TENS).
Patient is less than 6 months free from Botulinum Toxin (Botox) injection in the lower extremity.
Patient has baclofen pump with unstable dosing in the last 3 months.
Patient is unable or unwilling to comply with study procedures, including follow-up requirements.
Patient is participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results.
Patient is unable or unwilling to give written informed consent.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ankle-Foot Orthosis (AFO)	Ankle-Foot Orthosis (AFO)	Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide	WalkAide	Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Primary Outcome Measures

Name	Time	Method
Stroke Impact Scale (SIS) Composite Score	6 months	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.
Gait Velocity	6 months	Improved ambulation status, specific to increase in gait velocity (m/s)
Device Related Serious Adverse Events	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Modified Emory Functional Ambulation Profile Total Score	6 months	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.
Six Minute Walk Test	6 months
Modified Emory Functional Ambulation Profile Floor Time	6 months	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.
Modified Emory Functional Ambulation Profile Stair Time	6 months	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 .
Berg Balance Scale	6 months	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.
Modified Emory Functional Ambulation Profile Carpet Time	6 months	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 .
Modified Emory Functional Ambulation Profile Timed up and Go	6 months	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.
Modified Emory Functional Ambulation Profile Obstacle Course	6 months	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.

Trial Locations

Locations (29): The Los Angeles VA
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Los Angeles, California, United States
Rehabilitation Institute of Chicago
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Chicago, Illinois, United States
The Cleveland Clinic
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Cleveland, Ohio, United States
Hartford Hospital
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Hartford, Connecticut, United States
Guilford Neurologic Associates
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Greensboro, North Carolina, United States
The Dallas VA
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Dallas, Texas, United States
Magee Rehabilitation Hospital
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Philadelphia, Pennsylvania, United States
The San Francisco VA Medical Center
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San Francisco, California, United States
University of Minnesota Twin-Cities
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Minneapolis, Minnesota, United States
Oregon Health & Science University
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Portland, Oregon, United States
United Healthcare
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Johnson City, New York, United States
Casa Colina Centers for Rehabilitation
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Pomona, California, United States
The Loma Linda University Medical Center
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Loma Linda, California, United States
Cardinal Hill Rehabilitation
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Lexington, Kentucky, United States
Halifax Hospital
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Daytona Beach, Florida, United States
South Shore Neurologic Associates
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Patchogue, New York, United States
Marianjoy Rehabilitation
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Wheaton, Illinois, United States
Florida Hospital NORI
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Orlando, Florida, United States
SUNY Upstate Medical University
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Syracuse, New York, United States
FirstHealth of the Carolinas
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Pinehurst, North Carolina, United States
St. David's Rehabilitation Hospital
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Austin, Texas, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
Marshfield Clinic Research Foundation
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Marshfield, Wisconsin, United States
University of Illinois at Chicago
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Chicago, Illinois, United States
St. Mary's of Michigan
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Saginaw, Michigan, United States
Madonna Rehabilitation Hospital
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Lincoln, Nebraska, United States
Kessler Foundation Research Center
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West Orange, New Jersey, United States
Health Research Inc./Helen Hayes Hospital
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West Haverstraw, New York, United States
The Ohio State University Medical Center
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Columbus, Ohio, United States