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