Trial Information

Do you have foot drop as a result of a stroke?

Innovative Neurotronics Inc. is currently conducting a randomized, controlled clinical trial for patients who have had a stroke and are experiencing the condition commonly referred to as Foot Drop. The purpose of the trial is to compare the use of a functional electrical stimulation (FES) device with the standard of care Ankle-Foot Orthosis (AFO). The WalkAide is an external stimulator that allows patients with foot drop to ambulate. The device functions by using a microprocessor with a built in tilt sensor that allows for precise timing of stimulus to create a normalized gait pattern. The device fits on a small cuff, is about the size of a pager and can be worn with or without shoes.

Patient Inclusion Criteria:

Medical history of stroke (ischemic and/or non-ischemic)
Sub-acute and Chronic stroke patients that have hemiplegia/hemiparesis (foot drop)
Patients are eligible for Medicare or Medicare Advantage
Able to walk at least 10 meters with or without an assist device (excluding an AFO or WalkAide device)
Patients do not have severe COPD that would limit their ability for walking tests
Patients do not have an implantable cardiac pacemaker or defibrillator
Patients have the cognitive ability to understand commands
Patients are willing to maintain a follow up schedule for the course of the study to 1 year

Patient Exclusion Criteria:

Patient has ankle joint instability other than foot drop.
Need for an AFO for stance control of the foot, ankle and/or knee.
Patient has peripheral neuropathy that would obstruct or limit ambulation or participation in study procedures.
The patient has significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication
Patient is less than 30 days post stroke rehabilitation at time of enrollment
Patient is NYHA Class III or IV.
Patient has history of seizure disorder
Patient has aphasia, defined as incapacity to follow two-step 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 Botox injection in the lower extremity.
Patient has baclofen pump with unstable dosing in the last 3 months.

Julianne Williard, RN, CCRC, Study Coordinator
Guilford Neurologic Associates
912 Third St. Suite 101
Greensboro, NC 27405
Phone: 336-275-8671
Fax: 336-389-4339
Email: jwilliard@guilfordneurologic.com

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Research Center Information: Guilford Neurologic Associates

If you would like to learn more about participating in this study, please send an email message using the form below.

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