Hanger Orthopedic Group has completed enrolling patients for its Instride investigational device exemption (IDE) clinical trial.
The randomized, controlled, pivotal study, which enrolled 496 patients, was designed to study the effectiveness of WalkAide system and compare it with the ankle-foot orthosis brace designed to stabilize a paralyzed or weakened foot in a functional position.
Primary outcome measures include ambulation and activities of daily living, with the main study endpoint as the comparison of success between the two devices at six months.
Hanger Orthopedic Group CEO Thomas Kirk said, "We are pleased to reach this significant milestone on schedule and exactly two years to the day of enrollment of our first patient."
Instride clinical trial principal investigator and Rehabilitation Services Cleveland Clinic Mellen Center director Francois Bethoux said, "The INSTRIDE clinical trial is a one-of-a-kind endeavor that could facilitate reimbursement of this technology and set the model for additional studies to come."
WalkAide System comprises an external stimulator that applies electrical pulses to restore proper foot flexion for patients who have suffered an upper motor neuron disruption from a stroke, incomplete spinal cord injury, traumatic brain injury, multiple sclerosis, or cerebral palsy.