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INSTRIDE Stroke study compares two medical devices to manage foot drop

Adults who have had a stroke and are experiencing the condition commonly referred to as foot drop may be eligible to participate in the Upstate Medical University INSTRIDE Stroke study that compares the use of a functional electrical stimulation (FES) device with an ankle-foot orthosis, considered the standard of care for foot drop.

Upstate is one of 30 sites in the United States to recruit and test patients for the study. Margaret A. Turk, MD, professor of physical medicine and rehabilitation at Upstate Medical University, is leading Upstate’s participation.

Foot drop is the inability to raise the front part of the foot due to weakness or paralysis of the muscles that lift the foot. “Stroke is one cause of foot drop, as it is a neurodegenerative disorder of the brain that results in muscular problems,” said Dr. Turk. “The INSTRIDE Stroke study will determine if an FES device will show improvement over ankle-foot orthosis in clinically meaningful ways.”

The FES device used in the study is the FDA-approved WalkAide system. Unlike ankle-foot orthosis (brace) that controls the position and motion of the ankle, WalkAide is a battery-operated, functional electrical stimulation device that fits around the calf and functions by using a microprocessor with a built-in tilt sensor. The sensor allows for precise timing of stimulus to create a normal gait pattern in the patient. The device fits on a small cuff, is about the size of a pager and can be worn with or without shoes.

Volunteers will be selected at random to receive one of the two devices. Patients who are randomized to an ankle-foot orthosis will be eligible for a WalkAide at the end of the study.

To quality for the study, participants must,

• be three months post stroke and have foot drop,

• walk at least 10 meters with or without a device for assistance such as a cane or walker,

•  be currently covered by or eligible for Medicare or Medicare Advantage,

• not have an implantable cardiac device such as a pacemaker or defibrillator,

• have had no major surgery in the last 90 days, and

• be able to accurately complete study questionnaires and correctly use the WalkAide or ankle-foot orthosis.

Study participants will be followed for one year to determine if the WalkAide shows clinical improvement over the ankle-foot orthosis. Participants will undergo testing that includes a Berg Balance test, 10 meter walk test, and the Emory Functional Ambulatory Profile.

The INSTRIDE Stroke study is sponsored by Innovative Neurotronics Inc. For more information about the study, contact Lynne Romeiser Logan, PT, PhD, at Upstate Medical University at loganl@upstate.edu. Physicians who wish to refer a patient may have the patient call the study screening line at 877-318-7615 for inclusion into the trial.

Caption: Margaret Turk, MD, left, and physical therapist Lynne Romeiser Logan, display the two devices being compared in the study. Dr. Turk holds the WalkAide, while Dr. Logan displays the ankle-foot orthosis.

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