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

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.