Nation’s first clinical trial for rehabilitating infant stroke survivors to begin

Source: Virginia Tech News

Strokes are devastating events often associated with people over 65. But large numbers of infants have strokes, too.

Now, in the nation’s first multicenter pediatric stroke recovery trial, researchers and clinicians from 12 sites across the United States will evaluate an innovative therapeutic approach to help 8-month-old to 24-month-old infants.

Called I-ACQUIRE, the Phase III clinic trial will examine the effectiveness of a pediatric therapy to increase upper extremity skills, gross motor development, and cognition in 240 children nationwide who experienced strokes when they were under 4 weeks old.

Sharon Landesman Ramey, a professor and distinguished research scholar at Fralin Biomedical Research Institute at VTC, and Warren Lo, a pediatric neurologist at Nationwide Children’s Hospital and a clinical professor of pediatrics and neurology at The Ohio State University College of Medicine, are the lead principal investigators for the five-year, $13.5 million grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.

The I-ACQUIRE therapy will be tested in children at a three-hour and six-hour daily dose for four weeks to determine whether the more intensive dosage produces better outcomes or whether the three-hour daily sessions are as effective.

“It’s an eye-opener when people learn that babies, like adults, have a very high risk for stroke,” Landesman Ramey said. “About half of these infants will not have a permanent impairment, but for the remainder, stroke is a serious event that can produce lifelong, serious neuromotor problems. Given the impact of infant stroke on the child and families, it is astonishing that there is little or no scientific evidence to support the current rehabilitation approaches being used.”

Landesman Ramey and Stephanie DeLuca, the co-directors of Fralin Biomedical Research Institute Neuromotor Research Clinic, developed the treatment approach with colleague Karen Echols when they worked together at the University of Alabama at Birmingham (UAB).  They wrote the first manualized protocol of pediatric constraint-induced movement therapy titled “ACQUIREc Therapy,” from which I-ACQUIRE was developed.

Findings from the trial have the potential to transform clinical rehabilitation for more than 3,000 newly diagnosed infants annually in the United States who have strokes.

Perinatal stroke results from a blockage in an artery within the brain in children before they are born or during the first month of their lives. The stroke damage in the brain commonly results in muscle weakness, loss of motor control, and paralysis on one side of the body. It can also affect communication abilities and other developmental areas.

“We are honored to bring together expertise in pediatric neurology, psychology, rehabilitation, and neuroimaging to this unprecedented clinical trial,” Lo said. “Perinatal stroke is a life-altering neurological condition where there is a vast opportunity to improve early development and independence so that these children can reach their full potential.”

DeLuca and Landesman Ramey originally developed and tested a novel form of pediatric movement therapy, adapted from a form of treatment for adults known as Constraint-Induced Movement Therapy, when they worked together at the University of Alabama at Birmingham (UAB).

Key features include a specially constructed lightweight cast for the child’s non-impaired arm and hand that compels infants to increase their efforts to use the side impaired by the stroke. The casting always occurs jointly with an intensive rehabilitation protocol that is administered for many hours per day, five days a week for four weeks in a row.

Unlike adults, infants have not developed use of their upper extremities, so after stroke they are not “recovering” lost skills; instead, they are acquiring brand-new age-appropriate skills that the therapist induces through reinforcement and a process known as skills shaping.

“Three or six hours of therapy may sound shocking, but as both parents and therapists will tell you, young children love playing and interacting with people, food, objects, and toys — which is what the therapy feels like to the child. Of course, there are moments of frustration when the therapist is challenging the child,” Landesman Ramey said. “For the babies, effective therapy is a form of guided play. They learn how to use their impaired side in every kind of activity from eating, pulling to sit or stand, crawling or walking, to waving and hugging.”