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Therapeutic Areas: Neurology | Hematology | Cardiology/Vascular Diseases | Family Medicine
Disease Category: Stroke
Location: United States, NC
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.
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Date Last Changed:
July 19, 2013
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