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INFORMATION FOR

SPIRIT meeting intro and I-ACQUIRE Trial - Sharon Ramey and Warren Lo

October 26, 2021
  • 00:00Uh, I'm just going to make a few
  • 00:03brief comments and then turn it
  • 00:05over to our conference organizers.
  • 00:08But first of all, I just wanted
  • 00:11to say thanks to a few folks
  • 00:13thanks to our uh to Ruth Arnold,
  • 00:18who has really done a lot of work in the
  • 00:21last several weeks to pull everyone together,
  • 00:24both locally and across the
  • 00:25country to to come here.
  • 00:27This is our regional, coordinating.
  • 00:30Center for stroke Nets the the Southern New
  • 00:33England Partnership and Stroke Research,
  • 00:35Innovation and Treatment
  • 00:37Conference we affectionately refer
  • 00:39to ourselves as the spirit,
  • 00:41our regional coordinating
  • 00:43Center for Stroke NET,
  • 00:45and on behalf of the other Co principal
  • 00:48investigators that Brown and Hartford,
  • 00:51and at Northwell Karen Fury Mark Albertson,
  • 00:55Richard Chemist.
  • 00:55We're really glad that you can join us today.
  • 00:58I, I think over the course of the day.
  • 01:00We're very lucky because we're going
  • 01:03to hear really from so many of the
  • 01:06national leaders across the spectrum
  • 01:08of stroke net clinical trials.
  • 01:10I'll just say that the perhaps the most.
  • 01:17Part of stroke net.
  • 01:19That's my favorite part really.
  • 01:22Are these conferences and is the
  • 01:25ability for our centers to be able
  • 01:27to come together both nationally,
  • 01:29but especially within our
  • 01:32regional consortium.
  • 01:33So it's just great to have everyone here.
  • 01:35It's really exciting agenda.
  • 01:37I just want to take the moment to
  • 01:40introduce Shadi Yaghi so Shadi is
  • 01:43the stroke division chief at Brown.
  • 01:47And is incredibly involved in both,
  • 01:50contributing to spirit and to stroke.
  • 01:53Net clinical trial recruitment,
  • 01:55but has a number of different interests in
  • 02:00investigation and also to reach a Sharma.
  • 02:04Richa Sharma is here at Yale and
  • 02:07actually I believe was a former
  • 02:10stroke net fellow but now also
  • 02:12playing a number of roles and the
  • 02:15stroke program at Yale and is.
  • 02:17Also involved in pushing forward stroke
  • 02:20net trial concepts and has other
  • 02:22interests in stroke investigation as well.
  • 02:25So shoddy and reach,
  • 02:26I'll turn it over to you but
  • 02:28but thanks so much.
  • 02:29Thank you so much, Kevin.
  • 02:31I'm so excited about the
  • 02:33conference today and about
  • 02:34moderating it and welcome everyone.
  • 02:47Thank you as well for having us today.
  • 02:50We are delighted to have you all.
  • 02:53Join us today for the Spirit Conference
  • 02:56at thank you Shadi Yaghi for moderating,
  • 02:59along with me and today.
  • 03:02We will have a series of interesting
  • 03:05talks and we will start off the
  • 03:07morning with talks from representative
  • 03:10peas from the I acquired fleet
  • 03:13Smart and Arcadia CSI trials.
  • 03:16And then that will be followed by Doctor
  • 03:18Richard Benson talking about diversity,
  • 03:21equity and recruitment will have
  • 03:22a little bit of a break at noon.
  • 03:25Doctor Joe Broderick will be
  • 03:27talking about clinical stroke,
  • 03:29trial networks and particularly in the end.
  • 03:32And yes, stroke net infrastructure
  • 03:35will have lunch at 1:00 to 1:30.
  • 03:38Doctor Benson has kindly agreed to
  • 03:40talk with our young junior faculty
  • 03:43and Stroke Research fellows.
  • 03:46Or in training and then the afternoon
  • 03:49session will be led by Doctor
  • 03:51Jahnke where we will hear from
  • 03:54the P eyes from Aspire Arcadia.
  • 03:57And most and then that will be
  • 04:00followed by research presentations
  • 04:01from representatives from all
  • 04:03four of our spirit sites.
  • 04:07So without further ado,
  • 04:09we'd like to maybe go ahead and get
  • 04:12started with our first session,
  • 04:14which in which we'll hear from the P
  • 04:17eyes from the three trials I acquired,
  • 04:20smart in the Arcadia CSI study.
  • 04:26At Doctor Ramey or Doctor Lowe,
  • 04:29would you like to share your screen?
  • 04:34Yes, so once you let me share,
  • 04:37I will be happy to pull our
  • 04:40presentation up. Here we are and.
  • 04:44Let me start this slideshow from
  • 04:49here and let me have Sharon
  • 04:52start with the presentation.
  • 04:55Introduce you both if that's OK.
  • 04:59Thank you Doctor Ramey and Doctor Low
  • 05:02for joining us today to speak about the
  • 05:05I acquired trial studying rehabilitation
  • 05:07strategies for paralegal arterial stroke
  • 05:10Doctor Shannon Ramey is professor of
  • 05:12psychology and professor of psychiatry
  • 05:14and Behavioral Medicine at Virginia Tech.
  • 05:17Dr Warren Lewis of Pediatric neurologist
  • 05:20at Nationwide children and Clinical
  • 05:22professor of Pediatrics and Neurology
  • 05:24at Ohio State College of Medicine.
  • 05:26So, without further ado.
  • 05:31Well, thank you.
  • 05:32We're so pleased to be here and
  • 05:35today what we hope to accomplish
  • 05:38is letting you know the overview,
  • 05:41the design of our study.
  • 05:43But we ahead of time received some
  • 05:47wonderful questions from you.
  • 05:49One is how did we really pick
  • 05:51those dosages for the children?
  • 05:52I mean, three hours, six hours,
  • 05:54what's what's that rationale?
  • 05:56So we'll spend a minute
  • 05:58and share that with you,
  • 05:59and then we want to let you
  • 06:02know what's innovative,
  • 06:03not because we're trying
  • 06:05to get funded anymore,
  • 06:06but because we hope that those
  • 06:08of you who study different
  • 06:10dimensions of stroke across the
  • 06:12life spectrum might think about
  • 06:14some of our innovative features
  • 06:17and whether there are things that.
  • 06:19You can adapt to the kind of research you do,
  • 06:22especially if you work in rehab and recovery,
  • 06:26and then we got it funding for a new,
  • 06:28longer term follow-up will tell you
  • 06:30about and then we'll talk about some
  • 06:33other opportunities for collaborations,
  • 06:35because I always think things
  • 06:37like a regional conference really
  • 06:40are about what can we do next.
  • 06:42Even better, even bigger, more impactful.
  • 06:45So background on our history PA IS.
  • 06:49Covers both the neonatal period,
  • 06:52the first 28 days of life and
  • 06:54also the prenatal.
  • 06:55We presume strokes are there
  • 06:58based on clinical MRI data.
  • 07:00We estimate it's about one in 1100 or 1200.
  • 07:05Live verse,
  • 07:05so really much more common than people
  • 07:09recognize and hemiparesis occurs.
  • 07:12Maybe in about 40% of the children.
  • 07:14It's the most common lifelong,
  • 07:17under a motor impairment,
  • 07:19and many of the children have impairments.
  • 07:21And other developmental domains.
  • 07:23The biggest thing is that when
  • 07:26we launched this,
  • 07:27there was and still is not a true
  • 07:30consensus on how best to treat the children,
  • 07:34so they usually are referred for
  • 07:37therapy and then the therapy is a
  • 07:40combination of whatever the parents and
  • 07:42and the receiving referral specialists say.
  • 07:46Usually the children get OT and
  • 07:49PT often couple hours a week.
  • 07:51That's increased a little over the years.
  • 07:54And it's really not evidence based.
  • 07:56It's not highly specified and there's
  • 07:59been no infant toddler trial of
  • 08:02either constraint induced movement therapy.
  • 08:05The version adapted for children which
  • 08:08has been tested from age 3 up and small.
  • 08:14Phase One phase two trials,
  • 08:16but no adequately powered
  • 08:18infant toddler trial,
  • 08:19focused solely on children who have the
  • 08:23etiology of PA IS now when we designed it.
  • 08:27Next slide.
  • 08:30We did this because some of our team
  • 08:33were among the people who did the very
  • 08:36first adaptation from adult to Pediatrics.
  • 08:38I was part of that team.
  • 08:40Great honor,
  • 08:41great challenge.
  • 08:42We've already done three other multi
  • 08:45site worked for older children
  • 08:48and testing various components of
  • 08:51constraint induced movement therapy.
  • 08:53And why did we pick dosage?
  • 08:56It is the single most controversial
  • 09:00thing many parents but especially
  • 09:05clinicians MD's think.
  • 09:07Our original dose 6 hours a day.
  • 09:11Originally we did it for 21
  • 09:13days like that is way too much.
  • 09:16What child can have six hours of therapy?
  • 09:18Well if you're thinking of therapy
  • 09:20like a child sitting in a chair at a
  • 09:22table and someone handing the child
  • 09:24of lock and making them pick up the
  • 09:26block and doing that for six hours,
  • 09:28it would be atrocious.
  • 09:29But what we do is in the home it's play like.
  • 09:34It includes self-help skills kids.
  • 09:37Have you ever met a baby or toddler?
  • 09:39When he or she is awake, who doesn't
  • 09:42love to be played with and have fun?
  • 09:44Especially if it's fun with objects
  • 09:47and people they like to hang out with.
  • 09:50So children are active all day long
  • 09:53and basically the therapy becomes
  • 09:55integrated and we do it in the
  • 09:57children's homes and then this,
  • 10:00why dosage?
  • 10:01We wanted to really cover today and in
  • 10:04psychology going back to really the
  • 10:061930s and 40s there was this idea.
  • 10:08If you want a new habit.
  • 10:10For the rest of your life.
  • 10:12Do it for 21 days in a row.
  • 10:15I will confess the evidence behind.
  • 10:17It's like mediocre at best,
  • 10:19but it was widely accepted.
  • 10:21Do it for 21 days and if you
  • 10:24haven't tried it,
  • 10:2521 isn't a bad beginning for
  • 10:28changing your habit.
  • 10:29If you've ever tried to do
  • 10:31something that many days in a row.
  • 10:33So that's where we got the idea
  • 10:37originally and the idea of six hours.
  • 10:40Well,
  • 10:40six hours,
  • 10:41is about the number of hours that
  • 10:43typically developing children are
  • 10:45really active and awake and alert.
  • 10:48It also corresponds to the school
  • 10:51day it corresponds to child care.
  • 10:53If you subtract out the hours
  • 10:55they spend napping and resting,
  • 10:57so it's roughly what a full day of
  • 11:00activity is. So that's why 6 hours.
  • 11:03And then three hours is half a day,
  • 11:06and in other trials we have tested
  • 11:093 hours and have shown it does
  • 11:13produce significant gains and they
  • 11:16last at least for six months.
  • 11:19And I'm under an embargo from
  • 11:22the journal Pediatrics,
  • 11:23but one week from today we have an
  • 11:27article coming out in Pediatrics
  • 11:30comparing dosage for three to 8
  • 11:33year old children with hemiparesis
  • 11:35and we test and even lower dosage
  • 11:39than what we are doing,
  • 11:41and I acquired and turns out that
  • 11:43really lower dosage didn't produce
  • 11:45the changes I'm allowed to tell you
  • 11:47that since we've said that previously.
  • 11:49But Will put up the article on
  • 11:51stroke net on for you to be able
  • 11:54to access those of you interested.
  • 11:56And then the other thing we're
  • 11:58doing is we're getting a lot of
  • 12:00parent ratings besides our blinded
  • 12:02objective outcomes,
  • 12:03because no matter how talented
  • 12:06and assessor is.
  • 12:08A two hour session or even a 3 hour
  • 12:10session with an infant doesn't tell
  • 12:13you everything about that child's
  • 12:15repertoire and demonstrated everyday skills.
  • 12:18So of course the primary measure
  • 12:20will rely on blinded objective.
  • 12:23But we highly value parent
  • 12:25perspectives and I think we're the
  • 12:27maybe the only trial that from the
  • 12:30very first application and all the
  • 12:32way through we've had a consumer
  • 12:35or patient. In our case, parent council.
  • 12:38As partners in our research.
  • 12:42This is just to show you that the
  • 12:45preliminary data we had on 24 infants
  • 12:48and toddlers showed that they met or
  • 12:51exceeded what we said is our threshold,
  • 12:54which is the child will acquire 7.
  • 12:57Brand new emerging behavior skills.
  • 13:01EBS within a four week period and
  • 13:04for a little baby doing 7 brand new
  • 13:07things with arm in hand is a lot.
  • 13:10Next slide.
  • 13:11OK, Warren is going to take you
  • 13:14through a few minutes of a live
  • 13:17session and we have four other
  • 13:19video tape examples on our I acquire
  • 13:22website on stroke Note stroke NET.
  • 13:25If you want to see even more examples
  • 13:27of what's it really look like when
  • 13:29we're doing treatment, Warren.
  • 13:31Sure, let me start the video here and
  • 13:33there's no audio, so I'll voice over.
  • 13:36But the purpose of showing you this five
  • 13:38minute clip is to really illustrate some key
  • 13:42elements of the acquire protocol number one.
  • 13:45As Sharon said, the real challenge for the
  • 13:48therapist is to try to stimulate the child,
  • 13:51so this becomes a positive experience
  • 13:53to try to find those things
  • 13:56that motivates the child.
  • 13:58As you can see, this is at the very
  • 14:00beginning of the intervention.
  • 14:01And he's not particularly convinced
  • 14:03that this is in his best interest,
  • 14:05so she's trying to number one.
  • 14:08Stimulate him to use that affected extremity,
  • 14:13the right arm,
  • 14:14and to try to get him to reach.
  • 14:17And he's obviously not getting
  • 14:18it at this very early stage,
  • 14:21but the goal is to try to
  • 14:23start with simple movements.
  • 14:26First extension of that hand,
  • 14:28and not extension of the arm,
  • 14:31and not really engaging.
  • 14:32In a more complex measure,
  • 14:34and so this illustrates really a
  • 14:37couple of principles we're trying
  • 14:40to shape the child's behavior.
  • 14:41You're going to see that at
  • 14:44the end of this sequence,
  • 14:45she gives him a hug and gives
  • 14:48him some positive feedback,
  • 14:49so she's really trying to use operant
  • 14:52conditioning to gradually promote the
  • 14:54behavior that she wants him to accomplish,
  • 14:57and the other obvious feature is that
  • 14:59this is occurring in the home setting,
  • 15:01so it's easier for the child.
  • 15:03Really generalized this skills that he's
  • 15:05learned here to the home environment,
  • 15:08so you can say, well,
  • 15:09he's still fussing.
  • 15:10What has she really accomplished,
  • 15:12but you can see that he is actually
  • 15:15beginning to reach out spontaneously.
  • 15:17She doesn't have to she she?
  • 15:19She does promote or assist him
  • 15:22in out stretching his arm,
  • 15:25but he's beginning to do this
  • 15:28spontaneously by himself.
  • 15:29He's opening the fingers,
  • 15:30he's opening the hand.
  • 15:32It is clearly still a struggle.
  • 15:34But now he's beginning to reach
  • 15:37out for the toy in a more positive
  • 15:40and more voluntary demonstration
  • 15:42of what you're trying to achieve.
  • 15:45Now,
  • 15:45this illustrates that with this
  • 15:49continued operant conditioning,
  • 15:51this is now becoming a more
  • 15:52positive activity for the child.
  • 15:54He's no longer struggling.
  • 15:56He's actually reaching out.
  • 15:57He's using that impaired extremity,
  • 16:00and it's important to demonstrate
  • 16:02that it's not just.
  • 16:04Repetitions movement of the impaired arm.
  • 16:07He is clearly using the casted arms,
  • 16:10so this is a bimanual activity and
  • 16:12the therapist is trying to stimulate
  • 16:15him to use whole body movements.
  • 16:17So it's not just her sitting or him
  • 16:20sitting in a chair with her repeatedly
  • 16:23stretching and and flexing his arm,
  • 16:25but it's a more complex functional
  • 16:28series of movements for the child to
  • 16:32reach to crawl to support himself.
  • 16:34To open the uh fingers of that
  • 16:37right hand and you can see that
  • 16:40compared to those initial clips,
  • 16:42he's now a much more functionally
  • 16:45using that impaired extremity.
  • 16:46She has that toy that she's trying
  • 16:49to get him that she'll position,
  • 16:51and then this clip,
  • 16:53and then the following concluding clip
  • 16:55demonstrates the change that's really
  • 16:57occurred within a two to three week
  • 17:00interval from a child who's fussing
  • 17:02who's not able to use that extremity.
  • 17:05He's now able to support himself.
  • 17:07He's able to crawl.
  • 17:08You can see that he has a a really
  • 17:12a right sided hemiparesis that
  • 17:14right leg is not fully extending,
  • 17:16but he's able to use it much more
  • 17:19functionally than he was before, so again,
  • 17:21the emphasis is not just repetitive
  • 17:23movement of the apparent extremity,
  • 17:25but really bilateral use of the upper
  • 17:28extremities and more functional use
  • 17:30of the body and then the final clip.
  • 17:32I think really demonstrates and excuse the.
  • 17:35Relaxed attire for this particular example,
  • 17:39but you can see that he's spontaneously
  • 17:43going to position himself into the crawling.
  • 17:47Positioning he crawls over to this
  • 17:49toy and you can see that he's
  • 17:52actively trying to reach out for it,
  • 17:53and at the very end of the clip he will
  • 17:56actually reach out and grasp the toy.
  • 17:58So really,
  • 17:58over a 3 three and a half week
  • 18:00interval you can see that with
  • 18:02with a child who clearly has a
  • 18:05right upper extremity hemiparesis,
  • 18:06the intervention is extended his his use.
  • 18:11But really in a play like in a home like.
  • 18:16Environment,
  • 18:16so let me move to the next slide.
  • 18:19So how's the acquired trials set up?
  • 18:21Well,
  • 18:22we're going to recruit 240 children and
  • 18:25they will be randomized into equal groups.
  • 18:28I don't know if my mouse displays it,
  • 18:30but one group will get the
  • 18:32moderate 3 hour per day dose.
  • 18:34One group will get the six hour high dose
  • 18:39treatment and then 80 children will be
  • 18:43randomized to usual and customary care.
  • 18:45Whatever they can receive within the
  • 18:48community to serve as a control arm,
  • 18:51there will be a baseline assessment
  • 18:53using both blinded and parent ratings,
  • 18:55the children will be treated and the
  • 18:58active treatment will be centrally
  • 19:00monitored for fidelity and then the
  • 19:02children will be assessed immediately.
  • 19:04Post treatment and then it's
  • 19:07six six months post treatment.
  • 19:10Those children who were randomized
  • 19:12to the usual and customary arm have
  • 19:15an opportunity to re consent and
  • 19:17re randomize to the three or the
  • 19:20six hour arm once they've completed
  • 19:22that six month assessment and let
  • 19:24me mention some innovative features
  • 19:26of the acquired study.
  • 19:28Contrary to many previous
  • 19:30pediatric rehabilitation studies,
  • 19:32we're looking for efficacy,
  • 19:34not just at the post assessment post
  • 19:37treatment assessment with the children.
  • 19:40Have to maintain their gains,
  • 19:42both post treatment and it's
  • 19:44six months post treatment.
  • 19:45So really there needs to be a
  • 19:48sustained sensory motor function
  • 19:50beyond just immediately post treatment.
  • 19:53Thanks to our Yale colleagues,
  • 19:56we are working to collect genetic
  • 19:58samples and of course we're collecting
  • 20:00MRI samples for these children and
  • 20:03we want to test the question whether
  • 20:06genetic markers and imaging markers
  • 20:08predict the child's responsiveness
  • 20:10to treatment,
  • 20:11and I think that's a very
  • 20:13innovative feature of this study.
  • 20:14I've talked about the acquire
  • 20:17form and really illustrated in
  • 20:19the preceding of video and what other
  • 20:22what's additionally unique about?
  • 20:24Our study is that we're going to have
  • 20:27the parents provide information from
  • 20:29two surveys designed by a parent
  • 20:31council to really illustrate the parrot
  • 20:34experience in participating in these.
  • 20:36In this clinical study.
  • 20:38So where are we in terms
  • 20:40of the trial progress?
  • 20:42Our first child was enrolled about
  • 20:44two about two years ago, and today,
  • 20:47we've randomized 79 children,
  • 20:49which is about 33% of our projected total.
  • 20:53If you look to this graph
  • 20:55on the right hand side,
  • 20:57the red curve illustrates an ideal
  • 21:00idealized rate of recruitment,
  • 21:03and clearly we were delayed by the pandemic.
  • 21:07But you can notice that the blue
  • 21:10dots really illustrate the return
  • 21:12to the original rate of recruitment,
  • 21:14and it really begins to look
  • 21:16like we're re paralleling the
  • 21:18projected ideal rate of recruitment.
  • 21:20So we've included additional sites,
  • 21:22and we're hopeful.
  • 21:24That will be able to conclude the
  • 21:26trial at the projected conclusion
  • 21:28of the grant period.
  • 21:31Some of the challenges come.
  • 21:33I think it's important to recognize
  • 21:35that if you're going to do a study
  • 21:37where you rely where therapists and
  • 21:39assessors are key to the conduct
  • 21:41of the study, you have to prepare,
  • 21:44you have to assign ongoing resources
  • 21:47for continued training and certifying.
  • 21:49You have a natural influx and efflux
  • 21:52of of project staff and you just
  • 21:55have to prepare for that turnover
  • 21:57in that ongoing training.
  • 21:59As I mentioned earlier, COVID-19.
  • 22:01Interrupted the study,
  • 22:03but it is very intriguing.
  • 22:06There's ongoing parent increase
  • 22:07interest in the study,
  • 22:09and that's been a key driver
  • 22:11for our recruitment,
  • 22:12and I believe that that's why you
  • 22:14see that curve really approaching
  • 22:16the ideal range.
  • 22:17Initially we had trouble recruiting
  • 22:20African American children.
  • 22:21Stroke net had provided some
  • 22:24very helpful suggestions,
  • 22:25and we're at implementing those,
  • 22:28and our sites have been able to recruit now.
  • 22:32African American children up to about 7%,
  • 22:34so it's an improvement,
  • 22:36but we clearly have a ways to go
  • 22:37and for someone like myself who
  • 22:39had not worked within stroke net,
  • 22:41there was a steep learning curve
  • 22:43in terms of learning how to work
  • 22:45within the organization,
  • 22:46but clearly there's a lot of
  • 22:48strengths in terms of working with
  • 22:50it and establish trial network.
  • 22:52So let me turn the slides back
  • 22:54over to Sharon.
  • 22:58Thanks so much more and so
  • 23:00our 12 month follow-up study.
  • 23:02Well, I'm a developmental scientist and
  • 23:07Craig and I this month or finishing a
  • 23:10book about a study where we followed
  • 23:12the same babies who for 50 years.
  • 23:15So that's both how old we are
  • 23:16and how old those babies are.
  • 23:18So do I always want more
  • 23:19data as children get older?
  • 23:21Yes, is it a fishing expedition sometimes,
  • 23:24but we've learned a lot.
  • 23:25Meanwhile, this is not some broad.
  • 23:28Horrible fishing expedition that no
  • 23:30peer review group would fund appear.
  • 23:32We group group did fund it based on
  • 23:35the following rationale number one,
  • 23:37we are not changing the definition
  • 23:40of efficacy to require that the child
  • 23:43continue to not only maintain but
  • 23:46grow and develop another six months,
  • 23:49but we had compelling evidence from
  • 23:52the study that will be published.
  • 23:55And available next week in
  • 23:57Pediatrics that at 12 months.
  • 24:00Post treatment we found even bigger
  • 24:03effects of dosage difference is and we
  • 24:06think that's really about developmental.
  • 24:10Neuroplasticity, we think.
  • 24:12And this was true in the nonhuman.
  • 24:15I used to work with monkeys many decades ago,
  • 24:18but the nonhuman primate research on C.
  • 24:21IMT in stroke experimental stroke
  • 24:24models showed that you could get
  • 24:28the same short turn chain short.
  • 24:31Term changes with the low
  • 24:32dose as well as a high dose,
  • 24:35but the only rhesus monkeys that were
  • 24:37changed for the rest of the light.
  • 24:39Their lives were the ones
  • 24:41who got the high dose.
  • 24:42So we think probably at a neural
  • 24:47anatomical and functional systems level,
  • 24:50the higher dose might really be a
  • 24:53substrate for much greater growth,
  • 24:56and we want to study that,
  • 24:58so we'll be able to test whether
  • 25:01the dosages differ at 12 months.
  • 25:03But you know,
  • 25:04if they differ,
  • 25:05we're not sure it's just changes
  • 25:07in the brain.
  • 25:08It could be even that that
  • 25:10clip Warren showed today.
  • 25:11You can see how happy the children are.
  • 25:14And of course,
  • 25:15that child probably everyday participated
  • 25:17in about 15 to 20 different activities.
  • 25:19The child wasn't crawling all day long.
  • 25:23But they become so excited to see the changes
  • 25:28in our early years of doing this therapy.
  • 25:30We called it Olympic training.
  • 25:33Both children who prepare to compete
  • 25:36in the Olympics and children who are
  • 25:39musical performers under the age of 10.
  • 25:43They usually practice four to six
  • 25:45hours a day, almost seven days a week,
  • 25:49year in and year out.
  • 25:51So we really think that.
  • 25:53But they also these babies who have
  • 25:58the hemiparesis gets so excited and
  • 26:01we we have things like the parents
  • 26:03saying the child looks at the arm
  • 26:06that previously was scarcely used.
  • 26:08Some children actually totally neglected.
  • 26:10They look at their arm and some of the
  • 26:13children start to laugh or just wave
  • 26:15it around because they couldn't even
  • 26:17wave the arm around before and just
  • 26:20are so excited they learn to clap.
  • 26:22I mean they are so.
  • 26:24Motivated so maybe.
  • 26:26In addition to changing brain,
  • 26:28the child's willing to stick
  • 26:30with the difficult tasks that
  • 26:33at first makes you frustrated any
  • 26:35of you have ever been around a baby.
  • 26:37Do babies get frustrated
  • 26:39when they can't do something?
  • 26:40This is, this is how children grow.
  • 26:43You want to keep the frustration
  • 26:45to a minimum and we don't allow
  • 26:47our babies to cry or fuss over.
  • 26:49Is there a two minute limit
  • 26:50Warren or three minute?
  • 26:51Anyway, we don't let it happen forever.
  • 26:53We're really kind and considerate, but.
  • 26:56We are probably a little more
  • 26:59demanding than parents who never had
  • 27:02a child with a potential disability.
  • 27:05Often think my child can't do it.
  • 27:07It's not fair of me to demand that the
  • 27:11child try when the child can't help it.
  • 27:14He or she had a stroke,
  • 27:15so our our therapists are quite demanding,
  • 27:18but also very kind.
  • 27:19So we will be able in the 12 month study
  • 27:23to collect a lot of rich descriptive data.
  • 27:27About whether the parents,
  • 27:29the physicians and the therapist altered
  • 27:32their expectations for the child after.
  • 27:36They had I acquired and
  • 27:38whether the child change,
  • 27:40so we have historically written
  • 27:42about spillover effects,
  • 27:44and we didn't tell you until right
  • 27:46now we're measuring a lot of them,
  • 27:48so we don't try to teach language
  • 27:51and cognition,
  • 27:51and you know how to be a
  • 27:53nice sharing human being.
  • 27:55I mean,
  • 27:55we're focused on the arm in the hand mostly,
  • 27:58but lo and behold,
  • 28:00children who acquire those skills,
  • 28:02many of them begin to speak.
  • 28:04Many of them begin to laugh.
  • 28:06And interact and become way more
  • 28:09social rather than reserved and
  • 28:12passive or overly demanding.
  • 28:14And they have to now collaborate with
  • 28:18the therapist everyday so we see
  • 28:22psychological changes and will be
  • 28:24able to measure more about that topic.
  • 28:27In our 12 month follow up next slide Warren.
  • 28:31Opportunities will stroke overall
  • 28:34thank goodness across the whole
  • 28:38pediatric spectrum is kind of rare
  • 28:41but but we hope that there will be
  • 28:43people today in this audience and
  • 28:45also as you reach out to colleagues
  • 28:48who have ideas about different ways
  • 28:51and whether it's higher intensity
  • 28:54or combination therapies.
  • 28:57Adam curtain in Canada is combining.
  • 29:02Direct stimulation with more
  • 29:04traditional forms of therapy and
  • 29:07actually with C IMT and comparing.
  • 29:09What if you do one or the other or
  • 29:11you combine them? What are the benefits?
  • 29:14We'd love to see more trials like that.
  • 29:16Anyone who wants to go through the
  • 29:19challenging lengthy process and stroke.
  • 29:21Net,
  • 29:21we promise we will be at your side
  • 29:24and help you get funding and.
  • 29:30I really hope that we can get some more
  • 29:33rehab and recovery trials in Pediatrics
  • 29:36or those of you doing recovery.
  • 29:38Rehab in adults might think of well,
  • 29:41could we at least add a teenage or
  • 29:43school age child population and will
  • 29:45help you do the child portions?
  • 29:47So we want to see a lot more
  • 29:51pediatric trials.
  • 29:52And hope you'll get excited about that.
  • 29:58Kate last slide, I think says Q&A is.
  • 30:01Yes, we want to especially thank our Yale,
  • 30:05New Haven and Brown Stroke net team
  • 30:09for inviting us in our clinical sites.
  • 30:11If you don't already know,
  • 30:13we have University of Michigan.
  • 30:15We have Kennedy Krieger at Johns Hopkins.
  • 30:18We have UAB and Birmingham Boston.
  • 30:22We have a Harvard and the two
  • 30:24wonderful children's hospitals.
  • 30:26Charleston's are 14th site at MUSC Chicago.
  • 30:29We have a fabulous rehab
  • 30:33center there Cincinnati. Uh,
  • 30:35it's a great Children's Hospital Columbus.
  • 30:38Of course,
  • 30:39we're Warren is our New Haven and Brown site,
  • 30:44Philadelphia Chop and Roanoke.
  • 30:46We are a site,
  • 30:48San Diego,
  • 30:49UCLA and Saint Louis Washington
  • 30:52University website 13 and they're
  • 30:54going full steam ahead.
  • 30:56So any questions I see
  • 30:58under chat we had a nice
  • 31:02question from Kevin.
  • 31:03He's curious about the specificity of
  • 31:06the potential for the intervention.
  • 31:09To work on the arm versus the
  • 31:12hand and fingers, and does that.
  • 31:15We work on all of that and we work
  • 31:18on trunk control so anything that
  • 31:22promotes using the entire arm.
  • 31:27All of the you know,
  • 31:28dissociated movements at elbow and wrist,
  • 31:31and we use hand and fingers.
  • 31:32And it's not like the old fashioned where
  • 31:35you say oh we're going for a pincer grasp,
  • 31:37its developmental and
  • 31:39we train our therapists.
  • 31:41It takes a lot of training and give them
  • 31:43a lot of feedback but they also know
  • 31:46about some of the natural progression
  • 31:48of the entire upper extremity.
  • 31:50So we do all of that.
  • 31:52It's not like we have a goal.
  • 31:53OK, now release the hand.
  • 31:57But in natural activities,
  • 31:59the child's you know,
  • 32:01opening the hand, reaching,
  • 32:03grasping and then doing more
  • 32:05refined movements, and then we do,
  • 32:08he
  • 32:09had an additional part of the
  • 32:11question because for the the question
  • 32:13is how does that influence the
  • 32:15choice of your outcome measure is?
  • 32:17In other words, is there a differential
  • 32:20in terms of the results with the
  • 32:22arm versus the hand and fingers,
  • 32:24and does that influence the choice?
  • 32:27Outcome measure
  • 32:29well or outcome measure.
  • 32:31Is a composite that looks at all of
  • 32:35those components you've nominated.
  • 32:37It's not perfect.
  • 32:38I mean if we were totally honest,
  • 32:40we'd say there's not a perfect measure,
  • 32:42and then we want to done the research at all.
  • 32:44So we went with our best measure that
  • 32:46we had and we have multiple other
  • 32:50standardized tools and subscales.
  • 32:52And our measure is kind of different.
  • 32:54It requires that the child demonstrated
  • 32:57skill in two or more situations,
  • 33:00so we have lots of videotapes
  • 33:01on the children.
  • 33:02As well as the formal assessment,
  • 33:05and so it's a.
  • 33:07A pretty rigorous demonstration
  • 33:09of new skills and actually
  • 33:11children acquire some skills that
  • 33:14we're not even fully measuring,
  • 33:16so we're not capturing it all,
  • 33:18but we hope it's a good enough measure.
  • 33:22Some of the other measures were so
  • 33:24narrow if you just measure speed and
  • 33:26strength or hand or fingers or arms,
  • 33:29so it's a combined measure.
  • 33:31We're happy to share it with you and
  • 33:32let you know how it gets coated.
  • 33:35Ruth is giving us a two minute 2 minute
  • 33:37warning, so this is like football.
  • 33:40Maarten Lansberg is asking at the
  • 33:4212 month group what do you use
  • 33:45as the control group and do and
  • 33:47do the usual and customary kids
  • 33:50actually have the opportunity have?
  • 33:52Have they already had CIMT for the UCT group
  • 33:57so we only got funding to follow the
  • 34:00two original I acquired groups we
  • 34:03just didn't think it would be ethical
  • 34:06or the parents would have signed up
  • 34:08if they had to wait a whole year.
  • 34:10And weren't allowed to get any
  • 34:12form of C IMT, so it was a choice.
  • 34:15It's not the the best of science.
  • 34:20So we just will know about long
  • 34:22term maintenance and growth and
  • 34:24whether there's a differential for
  • 34:26those who did receive the treatment.
  • 34:28If the treatment turns out not to be
  • 34:30efficacious or we end the trial earlier,
  • 34:32of course we won't continue with
  • 34:34the 12 months, but it's it's.
  • 34:36It's a compromise design,
  • 34:38and we recognize its limits
  • 34:40and had to describe them a lot
  • 34:43in that application. Let
  • 34:44me squeeze in one last question.
  • 34:46Karen Fury is asking,
  • 34:47could you project?
  • 34:48What would that baby look like?
  • 34:50And from the video,
  • 34:51by the time he's school age,
  • 34:53in other words,
  • 34:54we've seen that interval change.
  • 34:56But would you have had spontaneous
  • 34:58recovery later on in childhood,
  • 35:00either with or without the intervention?
  • 35:04So that child and and
  • 35:07clinically we have treated.
  • 35:09Dozens of children, not hundreds,
  • 35:13repeatedly so often a parent who
  • 35:15has a child like that who was
  • 35:18told by the pediatric neurologist.
  • 35:20Your child will never use that arm period.
  • 35:23So all we're my work with is adaptive
  • 35:25equipment and learning to make the
  • 35:27other arm the left arm really good.
  • 35:29'cause you can get by in
  • 35:31life that way of course,
  • 35:32but but to us there are a lot
  • 35:34of limits with going only with
  • 35:37adaptive equipment and learning.
  • 35:38How to live a one armed life and
  • 35:41children like that often come
  • 35:43back to us about once a year.
  • 35:46Some of the children we've seen
  • 35:47seven or eight years in a row.
  • 35:49I will tell you one little girl whose
  • 35:51parents were told she'd never use.
  • 35:54That is a competitive tennis player,
  • 35:56and she uses both arms.
  • 35:58She's not going to make it to the Olympics,
  • 36:00but that's not her goal.
  • 36:01But she actually is choosing.
  • 36:03She's now going to college,
  • 36:05and she's going to neuroscience
  • 36:06that she was interested in rehab.
  • 36:08'cause she said people.
  • 36:09And like me, they gave up on me.
  • 36:11You know,
  • 36:12if I hadn't have gotten so we have seen and.
  • 36:16Broadly speaking,
  • 36:17we know of some families who've come
  • 36:19where the husband and wife almost
  • 36:22landed fighting because one of those
  • 36:24two people says my child is perfect now.
  • 36:26I mean, no one ever thought stroke and
  • 36:29hemiparesis a child would look normal.
  • 36:31Now some people don't notice mild things.
  • 36:33Some of us who look at it,
  • 36:34you know,
  • 36:35I think like everybody is impaired.
  • 36:36I I haven't ever seen anyone work work,
  • 36:39walk normally or use both hands normally,
  • 36:42but the recovery it isn't spontaneous.
  • 36:47All of these children will get more
  • 36:49therapy no matter what the question is.
  • 36:52Are they getting some bursts
  • 36:53of high intensity and I guess
  • 36:55how close with the final thing.
  • 36:58What we think is some of the
  • 37:00forms of traditional therapy might
  • 37:02have been really good,
  • 37:04but they didn't get enough of it.
  • 37:06And imagine you want to be a tennis
  • 37:08player or a pianist concert pianist,
  • 37:11and you only get a practice 2 hours a week.
  • 37:13How good are you may get?
  • 37:14In fact, you might even give up.
  • 37:16That's why most children in
  • 37:17elementary schools started.
  • 37:18With an instrument you know,
  • 37:20give it up by the time they're in high
  • 37:21school 'cause they didn't get good enough.
  • 37:23But if you went away to a
  • 37:25summer camp for a month.
  • 37:27And you came out playing whatever
  • 37:29instrument or tennis you know at a level.
  • 37:31Like you know, hey,
  • 37:32I'm gonna be really good.
  • 37:33Maybe you'd stick with it and we think
  • 37:36that's what's happening at therapy children.
  • 37:39If you go and you have a really nice
  • 37:41therapist and you have a great place session,
  • 37:42but you never get better,
  • 37:44pretty soon you know.
  • 37:46Therapy isn't so much fun.
  • 37:48OK,
  • 37:48thank you so much for inviting us and Ruth.
  • 37:51I'm sorry if I'm over.
  • 37:54Thank you Doctor Riley.
  • 37:55Thank you doctor.
  • 37:55Love her that very heartwarming talk.
  • 37:58I really appreciate.