Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop

Inclusion Criteria: * Have ankle dorsiflexion range of motion greater than or equal to neutral when assessed concurrent with test stimulation in sitting and standing and demonstrate adequate ankle and knee stability during gait at the time of screening * Have had at least one stroke of any etiology (e.g., ischemic, hemorrhagic,etc.) experienced greater than or equal to 3 months prior to study enrollment, as confirmed by independent medical records, and result in drop foot sufficient to require prior or current prescription for and/or use of an AFO * Have adequate cognition and communication abilities for informed consent, training and instructions, use of the L300, and provide feedback, to be demonstrated by either the subjects scoring greater than or equal to 24 (out of a possible 30) on the Mini Mental State Examination, or having a competent caregiver for these purposes * Must be 18 years or older * Have the ability to safely walk at least 10-meters with a maximum of 1 person assist * Have a self-selected 10-meter gait speed of less than or equal to 0.8m/s at the time of assessment * Have inadequate dorsiflexion/limb clearance or unable to achieve normal heel strike on ambulation without AFO * Be medically stable Exclusion Criteria: * Have fixed ankle contracture at greater than or equal to 5 degrees of plantar flexion in the hemiplegic leg with the knee extended * Have excessive pain in the affected leg, as measured by a score greater than or equal to 4 on a 10-point v…