FirstHealth’s physical therapy program provides clinical site for foot drop study
| Date Posted: 9/7/2011
PINEHURST – Fayetteville resident Harold Matthews was listening to the radio when he heard about a clinical trial for people who were having trouble walking after a stroke. He went immediately to the phone, called up the radio station to get the information and then contacted FirstHealth of the Carolinas’ Center for Outpatient Rehabilitation.
Fayetteville resident Harold Matthews received a WalkAide device to assist with his stroke-related foot drop at no cost after participating in a clinical trial offered at the FirstHealth Center for Outpatient Rehabilitation.
Within a few weeks, he was enrolled in a Pinehurst-headquartered study that compares traditional foot drop therapy to 21st century electronic technology.
Because the trial is randomized, Matthews, a utility company worker who was disabled by his stroke, received a traditional plastic brace and not the electronic WalkAide device being tested. His incentive for completing the yearlong trial was the promise of his own WalkAide – at no cost.
He got it this summer.
“I think it’s helping,” Matthews says. “My wife thinks it is, too. I just got it a few weeks ago. I’ve still got some getting used to it.”
Foot drop is caused by weakness on one side of the body (hemiparesis) that keeps the affected individual from picking up the stroke-impaired foot when walking. FirstHealth’s Center for Outpatient Rehabilitation, located on Aviemore Drive in Pinehurst, is one of only 30 test sites for the national INSTRIDE study.
Bruce Solomon, D.O., with Pinehurst Neurology, is principal investigator for the local study. Since the patient goal is 75, enrollment is continuing. Because the Pinehurst location was the first trial site in the Southeast, it has attracted patients from throughout the region.
“We have a lady who drives from Florida,” says Ginny Barbour, a physical therapist involved with the FirstHealth program.
Thirty patients have enrolled in the FirstHealth trial so far, and six – including Matthews – have completed the study and gotten their personal WalkAide. Four have had the device since they started the program.
Because of the weakness in the impaired leg, patients with foot drop can’t pick up their foot to clear their toes for walking. “They often trip over their toes, and they may fall,” says Jill Botnick, director of FirstHealth Outpatient Rehabilitation.
Unlike the traditional brace (ankle foot orthosis or AFO) that keeps the foot from catching the ground, the WalkAide issues an electric impulse to stimulate the nerve in the foot after a sensor recognizes the leg tilt indicating the beginning of a step.
According to Barbour, the AFO has been considered “gold standard” care for foot drop for decades, but it has its drawbacks. “Mr. Matthews wore it for a year, and he didn’t like it,” she says.
The AFO fits inside the shoe, limiting the type and style the patient can wear to lace-ups of at least a half-size larger than usual and requiring different sizes for each foot. Matthews found the arrangement awkward and uncomfortable.
“I had to buy shoes two sizes too big,” he says. “I looked like Bozo the Clown going down the street walking.”
Since it is worn just below the knee, the pager-sized stimulator can be worn with a variety of shoe styles.
To be eligible for the WalkAide trial, a patient must have had the stroke at least 90 days before beginning the study and completed physical therapy at least 30 days previously. This ensures that any improvement in gait is caused by the device and not medical intervention or physical therapy.
Prospective participants must also be Medicare-eligible, although not necessarily 65 years of age if medically disabled.
Because of the necessary nerve involvement, the stimulator is helpful only to patients dealing with the effects of conditions involving the brain or spinal cord, such as stroke or incomplete spinal cord injury, and is not appropriate for other causes of foot drop, including diabetic neuropathy.
Since enrollment includes a screening that indicates how well the patient walks, each study site is required to have a mapping system to record walking speed and step length. A $30,600 grant from the Moore Regional Hospital Foundation provided the funding for the GAITRite system used in the FirstHealth program.
Because some insurance companies consider the WalkAide an investigational device, it is not covered by Medicare for stroke and some patients find its $5,000 to $6,000 cost prohibitive.
While the prospect of acquiring his own no-cost WalkAide provided an incentive for Matthews to complete the program, he was also encouraged to stay the course by the helpful FirstHealth staff.
“They were real good with me up there,” he says. “They worked with me real good.”
If you have had a stroke and are experiencing difficulty walking, call (877) 232-3189 toll-free to learn more about the INSTRIDE clinical trial.