Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)
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.


Options:
A: Inclusion Criteria:

* 6 months post stroke
* Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity
* Short Blessed Test Score of 8 or less
* Unstructured Mesulam with 2 or less omissions

Exclusion Criteria:

* Dementia
* Severe spasticity in affected upper extremity
* Unilateral Visual Inattention (neglect)
* Contracture(s) in the affected upper extremity
* Botox injections administered within 9 months
* Aphasia which limits effective communication
B: 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.
C: Inclusion Criteria:

* Have ankle dorsiflexion range of motion greater than or equal to neutral when assessed concurrent with test stimulation in sitting and standing and demonstrate adequate ankle and knee stability during gait at the time of screening
* Have had at least one stroke of any etiology (e.g., ischemic, hemorrhagic,etc.) experienced greater than or equal to 3 months prior to study enrollment, as confirmed by independent medical records, and result in drop foot sufficient to require prior or current prescription for and/or use of an AFO
* Have adequate cognition and communication abilities for informed consent, training and instructions, use of the L300, and provide feedback, to be demonstrated by either the subjects scoring greater than or equal to 24 (out of a possible 30) on the Mini Mental State Examination, or having a competent caregiver for these purposes
* Must be 18 years or older
* Have the ability to safely walk at least 10-meters with a maximum of 1 person assist
* Have a self-selected 10-meter gait speed of less than or equal to 0.8m/s at the time of assessment
* Have inadequate dorsiflexion/limb clearance or unable to achieve normal heel strike on ambulation without AFO
* Be medically stable

Exclusion Criteria:

* Have fixed ankle contracture at greater than or equal to 5 degrees of plantar flexion in the hemiplegic leg with the knee extended
* Have excessive pain in the affected leg, as measured by a score greater than or equal to 4 on a 10-point visual analog scale
* Participation, within the past 3 months, currently, or during the course of the study in any interventional clinical studies without the Sponsor's approval
* Have a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant
* Have a lower motor neuron disease or injury with inadequate response to stimulation
* Have significant swelling/edema in the leg extending up to the knee
* Have a history of chronic skin problems/conditions or cancerous lesion present or suspected in close proximity ot the expected site for L300 stimulation
* Are pregnant or plan on becoming pregnant in the next 45 weeks
* Have had botulinum toxin(type a or b) to the hemiplegic leg or arm within the past six weeks or plan to have botulinum toxin treatments during the course of the study
* Expectation of a significant change in the subject's spasticity medications during the course of the study for the effected leg
* Have unstable seizure disorder (average of greater or equal to 2 seizures per month)
* Have a pre-existing significant orthopedic conditions that are, a that investigator's discretion, determined as likely to limit ambulatory progress (e.g., total hip replacement \[non-metallic\], total knee replacement \[non-metallic\], limited lower extremity (LE) range of motion (ROM), rheumatoid arthritis, osteoarthritis, or other fracture or dislocation that underlies the expected site for L300 stimulation)
* Have a complete hemisensory loss ipsilateral to foot drop
* Used the L300 or other FES device for foot drop (e.g., Odstock Drop Foot System (ODFS), WalkAide by Innovation Neurotronics, etc.) for greater than or equal to 3 hours within the last 6 months prior to study enrollment
* Have major post-stroke depression (PHQ-9 greater than or equal to 10) that is not medically managed with antidepression medication and/or psychotherapy
* Currently or planning on participating in a neuro-rehabilitation physical therapy (PT) or occupational therapy (OT) program or new independent exercise programs with enrolled in the study. However, injury or a change in condition requiring PT or OT that would not affect gait outcomes maybe assessed by an off-site study committee, on a case-by-case basis
D: Inclusion Criteria:

* Stroke survivors \>90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
* Age: 18-80 years
* Unilateral hemiparesis
* Medically stable
* Sufficient endurance \& motor ability to ambulate at least 30 feet continuously with minimal assistance \[requiring contact guard to no more than 25% physical help\] or less without the use of an AFO
* Berg Balance Scale score of 24 or greater without any assistive devices
* Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
* Demonstrate foot-drop during ambulation such that gait instability \[need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls\] or inefficient gait patterns \[gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes\] are exhibited
* Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
* If using an AFO, willing to terminate its use and comply with study requirements

Exclusion Criteria:

* Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
* Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
* Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
* Absent sensation of the affected lower limb
* History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability
* Demand pacemakers or any other implanted electronic systems
* Pregnant women
* Uncontrolled seizure disorder
* Parkinson's Disease
* Spinal cord injury
* Traumatic brain injury with evidence of motor weakness
* Multiple sclerosis
* Fixed ankle plantar flexor contracture
* Peroneal nerve injury at the fibular head as the cause of foot-drop
* Uncompensated hemineglect
* Severely impaired cognition and communication
* Painful hypersensitivity to NMES of the common peroneal nerve
* Inadequate social support (potential unlikeliness to comply with treatment \& follow-up)
* History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry
* Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation

Answer: B