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

Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)

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.