Dr Young you said "I think that this is because regeneration takes a long time and we are not seeing regenerating fibers appear on the DTI/MRI scans until 6 months." this may be a dumb question but if your not seeing growth until 6 months then why arnt you just waiting until the 6 month mark before you start the walking therapy? Wouldnt that save alot of money to take away that 6 months of therapy if its not helping any?
It is not a dumb question. We don't know when is the best timing for the locomotor training. To cover all the bases, we are planning to train half of the patients for a full year in China. We have seen the bundles of fibers crossing the injury site only in 2 of 5 subjects to date. It is important to confirm this in larger numbers of subjects.
The video I showed was an individual at 12 months after receiving UCBMC cell transplant. The person was about 4 years after injury when he received the transplant. This person did not have big changes in motor or sensory scores. Yes, one subject has achieved a KLS score of VI but most have been KLS IV. A majority of the transplanted chronic subjects have achieved KLS scores of IV. Unfortunately, several lost function when they went home and sat in a chair for 6 months without walking.
In my observations of chronic ASIA A patients who have had no untethering surgery and no cell transplant, few (probably <10%) recover to KLS IV. The question that we posed to the Kunming group was how many subjects who had untethering alone showed improved walking. They have seen patients get to KLS IV after untethering surgery. They told us that they have untethered and trained 300 subjects. They are collecting that data for us now.
From preliminary power analyses (what one does to estimate the number of patients necessary to show statistically significant effects), we think that 15 subjects per treatment group will show statistically significant effect if half or more subjects recover to KLS IV after untethering surgery and transplantation, compared to only a quarter of subjects who receive untethering surgery alone. If so, this means that we can reduce the number of subjects in China to 120 as opposed to our original 400. With four treatment groups with 30 each, we can randomize half of the subjects in each group to locomotor training at Kunming. They have agreed to do this.
Wise.
Great, thanks for the detailed responses! Is there any indication that the subjects are plateauing at KLS IV or is this simply where they leave the hospital once training is complete? If they do plateau, do you have any ideas about how to move to more functional walking? Perhaps other ideas from the rehab community could help here.
Even if functional walking isn't achieved, it may be a good idea moving forward to monitor the impact on muscle and bone of the continued walking (have you done this?)... There could be substantial therapeutic benefits (increased bone density, reduced risk of decubiti) of the walking in spite of it not being functional.
The video I showed was an individual at 12 months after receiving UCBMC cell transplant. The person was about 4 years after injury when he received the transplant. This person did not have big changes in motor or sensory scores.
...
Wise.
Wise,
what is the motor and sensory score of the individual showed in the video?
Is there any DTI of this individual? Even just post transpalant it would be interesting to see.
About DTI, how is it possible to distiguisch the ascending axons (dark blue) from the descending axons (light blue)? I didn't know that this is possible.
About the trial in Norway can you point me to an official source in Norway that can confirm info about the trial being planned to start this year?
Paolo
In God we trust; all others bring data. - Edwards Deming
Sorry, just another point on the walking and it's functionality; it makes sense, I suppose, but a little worrisome that the gains in locomotion were lost when the subjects went home and just "sat in a chair". Did they not continue with therapy at all on their own (I'm guessing they didn't have the resources I.e. something like a walking cart)? Because if the walking isn't yet at a functional level, it's not like individuals can engage in intensive walking therapy indefinitely... so I guess this is just further to my last point of how to break through those plateaus. I'm guessing also the maintenance of locomotion would require less training than what it took to get it in the first place (you mention they regain it after several weeks of practice).
Great, thanks for the detailed responses! Is there any indication that the subjects are plateauing at KLS IV or is this simply where they leave the hospital once training is complete? If they do plateau, do you have any ideas about how to move to more functional walking? Perhaps other ideas from the rehab community could help here.
Even if functional walking isn't achieved, it may be a good idea moving forward to monitor the impact on muscle and bone of the continued walking (have you done this?)... There could be substantial therapeutic benefits (increased bone density, reduced risk of decubiti) of the walking in spite of it not being functional.
Originally posted by ay2012
Sorry, just another point on the walking and it's functionality; it makes sense, I suppose, but a little worrisome that the gains in locomotion were lost when the subjects went home and just "sat in a chair". Did they not continue with therapy at all on their own (I'm guessing they didn't have the resources I.e. something like a walking cart)? Because if the walking isn't yet at a functional level, it's not like individuals can engage in intensive walking therapy indefinitely... so I guess this is just further to my last point of how to break through those plateaus. I'm guessing also the maintenance of locomotion would require less training than what it took to get it in the first place (you mention they regain it after several weeks of practice).
ay2012,
What can I say? We had all hoped that people would continue walking when they go home. But, I guess that they did not. That is why we are thinking of having the subjects stay for a year in the walking program.
We are having trouble getting the patients to come back to the hospital. So, we decided to solve the problem of getting them to come back by keeping them for a year. We can then get all the studies.
If anybody sits on their butt for 6 months, they would stop walking.
what is the motor and sensory score of the individual showed in the video?
Is there any DTI of this individual? Even just post transpalant it would be interesting to see.
About DTI, how is it possible to distiguisch the ascending axons (dark blue) from the descending axons (light blue)? I didn't know that this is possible.
About the trial in Norway can you point me to an official source in Norway that can confirm info about the trial being planned to start this year?
Paolo
There was no change in motor and sensory scores. We did not have DTI on the patient. We can take the ascending and descending fibers into or out of the pictures.
PROFESSOR THAT MADE YOU FOR THE REHABILITATION OF quadriplegic?
Hi, fti. Are you asking whether this walking training can be applied to people with quadriplegia? About 25% of the patients in this study have cervical spinal cord injury (below C5). Obviously, it is harder for people with high quadriplegia to do locomotor training but most people that have neurological levels of C5 (i.e. have deltoids and biceps) are able to train with these walkers.
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