walkaide compared to ankle-foot orthosis (afo) in stroke patients

Conditions: Stroke

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.

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.