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

Completed

Phase N/A Results

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.