For Patients: INSTRIDE Study 

Have you had a stroke?

Do you have difficulty walking?

If you have suffered a Stroke and have difficulty walking;  you may have a condition that is commonly referred to as Foot Drop. This condition is also known as hemiparesis (weakness on one side of the body) and that’s what’s preventing you from being able to pick up your foot when walking.

Innovative Neurotronics Inc. is currently conducting a clinical trial that could possibly offer help for patients who are experiencing foot drop. The clinical trial is called INSTRIDE and will compare the use of the WalkAide device vs. the use of traditional Ankle-Foot Orthosis (current standard of care) in people who have suffered a stroke resulting in difficulty walking due to foot drop.

 

The Device  

The WalkAide is a small, electrical stimulator that is worn just below the knee and is about the size of a pager. It stimulates the nerve in your foot that allows you to pick up your foot when you take a step. The device fits on a small cuff, is about the size of a pager and can be worn with or without shoes.

 

About The Trial

The trial compares the WalkAide to a standard brace called an ankle foot orthosis (AFO). AFO is a more traditional brace that keeps your foot in a rigid position so that you can keep your foot from catching the ground while walking. Testing measurements will be performed at scheduled follow up visits. To participate in the study; you will be required to attend all scheduled visits throughout the course of a year.  

Medicare currently covers the use of the WalkAide for patients who have foot drop due to an incomplete spinal cord injury. The purpose of the study is to determine the benefit of WalkAide vs. an AFO.

To help examine the safety and effectiveness of the WalkAide device with Functional Electrical Stimulation (FES) therapy, study participants will be asked to perform physical tests with either the WalkAide device or an or Ankle-Foot Orthosis (AFO).  This study will consist of seven study visits over 12 months.  On the first visit, patients will be screened to confirm that they are eligible to participate in the study.  Screening procedures may include neurological assessment, walking tests, balance tests, a nerve stimulation test, and questionnaires. 

Patients may be compensated for each visit to cover parking and incidentals.  If they do not finish the study, patients will only be paid for visits that were completed.

For more information please contact us at

 888-850-8625

 

Are You a Good Candidate?

If you are interested in participating in the study; there are certain qualifying criteria: 

  • You’re experiencing the condition commonly referred to as Foot Drop after having a stroke at least 90 days ago
  • You’re able to walk at least 10 meters with or without a device for assistance such as a crutch or walker
  • You are currently eligible for Medicare or Medicare Advantage
  • You do not have an implantable Cardiac device such as a pacemaker or defibrillator
  • You have not  had  bypass surgery or other cardiac procedures in the last 6 months
  • Are able to accurately complete study questionnaires and correctly use the WalkAide or AFO
  • Positive response to personal nerve stimulation testing
  • You’re willing and able to give written informed consent and will comply with all study procedures, including attending all required study visits

 To find out if you qualify to participate in the trial or for more information please contact us at

888-850-8625