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

October 26, 2021

ID7071

To CiteDCA Citation Guide

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.