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Therapeutic Areas: Neurology | Hematology | Cardiology/Vascular Diseases | Family Medicine
Disease Category: Stroke
Location: United States, NC

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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
Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

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

View Map

Research Center Information: Guilford Neurologic Associates

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 180650

Date Last Changed: July 19, 2013


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