The INSTRIDE Stroke Study
Enrollment for the INSTRIDE study is now complete and the study has been closed.
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.
The WalkAide is currently 510 (k) cleared to aid in ambulation for patients who have suffered an upper motor neuron disruption such as Incomplete Spinal Cord Injury, Traumatic Brain Injury, and Cerebral Palsy in children.
If you would like more information about the WalkAide, please visit For Medical Professionals page or call 888-884-6462
About the INSTRIDE Trial
Here are a few important things to know about the INSTRIDE trial.
IDE randomized study
496 stroke patients are enrolled
30 investigational sites in the United States
Patients who are enrolled in the study were randomly assigned to receive either a WalkAide or AFO
Patients who are randomized to the AFO are eligible for a WalkAide at the end of the study
Patients will be followed for a period of one year to determine if the WalkAide will show improvement over the AFO in clinically meaningful endpoints
Study is registered on the web at Clinicaltrials.gov
The 30 investigative sites are responsible for testing the patient at intervals. Testing includes a Berg Balance test, 10 meter walk test, and the Emory Functional Ambulatory Profile. All routine care and normal follow up visits will remain with the treating physician.