Functional Electrical Stimulation for Footdrop in Hemiparesis

Completed

Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
- Age: 18-80 years
- Unilateral hemiparesis
- Medically stable
- Sufficient endurance & motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO
- Berg Balance Scale score of 24 or greater without any assistive devices
- Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
- Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited
- Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
- If using an AFO, willing to terminate its use and comply with study requirements

Exclusion Criteria

- Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
- Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Absent sensation of the affected lower limb
- History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability
- Demand pacemakers or any other implanted electronic systems
- Pregnant women
- Uncontrolled seizure disorder
- Parkinson's Disease
- Spinal cord injury
- Traumatic brain injury with evidence of motor weakness
- Multiple sclerosis
- Fixed ankle plantar flexor contracture
- Peroneal nerve injury at the fibular head as the cause of foot-drop
- Uncompensated hemineglect
- Severely impaired cognition and communication
- Painful hypersensitivity to NMES of the common peroneal nerve
- Inadequate social support (potential unlikeliness to comply with treatment & follow-up)
- History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation