Clinical trial NCT01087957: WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
Official title: Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Innovative Neurotronics
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Gait Velocity
timeFrame: 6 months
measure: Stroke Impact Scale (SIS) Composite Score
timeFrame: 6 months
measure: Device Related Serious Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Six Minute Walk Test
timeFrame: 6 months
measure: Modified Emory Functional Ambulation Profile Total Score
timeFrame: 6 months
measure: Modified Emory Functional Ambulation Profile Floor Time
timeFrame: 6 months
measure: Modified Emory Functional Ambulation Profile Carpet Time
timeFrame: 6 months
measure: Modified Emory Functional Ambulation Profile Timed up and Go
timeFrame: 6 months
measure: Modified Emory Functional Ambulation Profile Obstacle Course
timeFrame: 6 months
measure: Modified Emory Functional Ambulation Profile Stair Time
timeFrame: 6 months
measure: Berg Balance Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: The Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: The Los Angeles VA
state: California
city: Pomona
country: United States
facility: Casa Colina Centers for Rehabilitation
state: California
city: San Francisco
country: United States
facility: The San Francisco VA Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Daytona Beach
country: United States
facility: Halifax Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital NORI
state: Florida
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Wheaton
country: United States
facility: Marianjoy Rehabilitation
state: Illinois
city: Lexington
country: United States
facility: Cardinal Hill Rehabilitation
state: Kentucky
city: Saginaw
country: United States
facility: St. Mary's of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Twin-Cities
state: Minnesota
city: Lincoln
country: United States
facility: Madonna Rehabilitation Hospital
state: Nebraska
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
city: Johnson City
country: United States
facility: United Healthcare
state: New York
city: Patchogue
country: United States
facility: South Shore Neurologic Associates
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: West Haverstraw
country: United States
facility: Health Research Inc./Helen Hayes Hospital
state: New York
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Magee Rehabilitation Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: St. David's Rehabilitation Hospital
state: Texas
city: Dallas
country: United States
facility: The Dallas VA
state: Texas
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Francois Bethoux, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy TM, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2014 Sep;28(7):688-97. doi: 10.1177/1545968314521007. Epub 2014 Feb 13.
citation: Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy T, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):911-22. doi: 10.1177/1545968315570325. Epub 2015 Feb 4.