Clinical Trial Details


Research Study Summary

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.

To Learn more

CW ID: 180650
Date Last Changed: July 19, 2013

Clinical Trial Snapshot

Both Male and Female
Overall Status
Facility Type


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

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Research Center Information:

Guilford Neurologic Associates

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