So the I-ACQUIRE trial was presented in February at the International Stroke Conference. And just to recall what the I-ACQUIRE trial was, it was looking at young infants and young children, 18 months to three years, who had had a stroke near the time of their birth. And they had what most people would call cerebral palsy, but one side of the body wasn’t working very well because of the stroke...
So the I-ACQUIRE trial was presented in February at the International Stroke Conference. And just to recall what the I-ACQUIRE trial was, it was looking at young infants and young children, 18 months to three years, who had had a stroke near the time of their birth. And they had what most people would call cerebral palsy, but one side of the body wasn’t working very well because of the stroke. And the idea was that we could do a very intensive therapy for these young infants and children. And it was designed to be at their age level, almost like very intensive play, not like therapy you’d get with an adult, but playing with things, doing the normal activities you would do, and doing it in two doses. One, six hours a day, seems like a lot, but it’s like being intensely working with the child for six hours, and one for three hours a day, and then the usual care, in which all these kids were getting some type of therapy, but in a much less amount, maybe once a week or twice a week, maybe, but not this intensive therapy. And the therapy involved actually taking the good hand and putting it in a cast. And so you couldn’t use that. So the child was forced to use the hand that was affected and then do these therapies. And what we found was that the children who had this aggressive type of therapy, modified constraint, constraining the one arm, they had a lot of improvement in their arm that was affected by the stroke, it was greater than those that had the higher use of higher therapy amount for six hours. It was present after therapy, and it was also continued out to six months, but also the group that had the highest dose seemed to have the most benefit. But the other, the control group, also got better some. So in terms of the primary endpoint of the trial, which we made seven different criteria, there’s a scale that people put together that did not meet the primary endpoint, but that was really shooting for, I would say, a grand slam, of using it’s like almost like you couldn’t believe how much better they are, but we did see, I would say, lasting but prominent effects, prominent effects of benefit for that right arm or left arm, whichever was affected. But it means we have more work to do, and the data for that is currently under review by a journal for publication.
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