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Thread: Dr. Wise, C4/5 Incomplete 24 yr. undergrad male looking for advice and guidance

  1. #11
    In the planning and design of the SCINetUSA trial, we spent some time discussing how much rehabilitation/exercise we can ask participants in the trial to undergo. I proposed that we stipulate a 6-week period of outpatient rehabilitation where the person would come 5 days a week and work for 3-6 hours a day. During that time, the person would get some physical therapy (range of motion) and then stand in a standing frame for an hour. If the person can do some stepping (i.e. swivel the hips to move the legs while weight-supporting with the arms and upper torso), the person would then spend 2 hours walking in an overground walking device. If the person cannot do stepping, they would train in on a treadmill until they are able to graduate to the overground walking device. The goal of the training is to get the person walking in the device. At the end of the 6 week out-patient training period, if they can show that they are able to use the device safely and effectively for walking, they can take the device home.

    We debated whether this clinical trial would be so disruptive that only unemployed people would be able to participate in the trial. After much internal discussion and some discussions with people with spinal cord injury, I believe that it is reasonable to expect people to participate in the clinical trial, undergo 6 weeks of intensive outpatient training, go home and do about 3 hours a day of locomotor training, and then continue at one hour a day for the rest fo the time. So, basically, to participate in the clinical trial, people who are employed or going to school would take 3 months leave of absence or vacation. That is one of the reasons why we are aiming to initiate the phase 3 trial in June, July, and August (summer vacation months for most college or graduate school).

    In my opinion, to maximize the likelihood of motor recovery, we need to encourage everybody to try to engage to the same intensity and duration of training and exercise. Note that people who are successful, i.e. who are able to walk and do more, will actually train and exercise more. This will tend to separate out those who recover from those who don't recover. As long as people in all the treatment groups were to work to the same degree and were given the same opportunity, the comparison of recovery amongst the treatment groups would be valid. I have been thinking about how we would monitor the activity of each person. I was thinking of having every person wear a pedometer and then recording the number of steps that the pedometer shows every day. For example, there is a device called "Fitbug" which is a pedometer with a computer program that will upload the daily walking information to a web site. http://www.fitbug.net/v2/about.php

    Another worry that we have is comparing walking recovery of people who have cervical versus thoracic injuries. For participants who have lower thoracic levels and incomplete injuries, walking should be easier. Likewise, people with high quadriplegia would not have the arm strength to be able to do weight support on the walking device. In the main trial for adults, we are planning to test subjects who are C5 to T10 inclusive. Those who are C5 means that they have at least biceps. Those who are T10 should have sensation down to their belly button and many may even have hip flexors (psoas) that would allow them to swing their hips to get stepping. When we randomize the subjects to the treatment groups, we will stratify the subjects by injury level and randomize within each injury level, to insure that we have equal numbers of subjects at each injury level. Finally, we will be comparing change scores, i.e. change from pre-treatment to post-treatment.

    In summary, we are proposing that the main SCINetUSA trial to have the following rehabilition. First, before the treatment phase of the trial, the subjects will be examined three times over a period of 6 months, to ensure that their neurological function is stable (neither improving nor declining) and encouraged to stand an hour a day (in a standing frame). Second, after surgical transplant therapy, the subjects are given a week to recuperate before they start an intensive outpatient locomotor training. If they are not able to step, they will under a 6-week period of treadmill locomotor training to get them to the point where they can walk with a weight-supporting overground locomotor device. They are encouraged to walk up to 3 hours a day for another 6 weeks. After that, they are expected to walk at least an hour per day. We will be monitoring their daily walking with pedometers.

    Wise.

  2. #12
    Quote Originally Posted by Wise Young View Post
    In the planning and design of the SCINetUSA trial, we spent some time discussing how much rehabilitation/exercise we can ask participants in the trial to undergo. I proposed that we stipulate a 6-week period of outpatient rehabilitation where the person would come 5 days a week and work for 3-6 hours a day. During that time, the person would get some physical therapy (range of motion) and then stand in a standing frame for an hour. If the person can do some stepping (i.e. swivel the hips to move the legs while weight-supporting with the arms and upper torso), the person would then spend 2 hours walking in an overground walking device. If the person cannot do stepping, they would train in on a treadmill until they are able to graduate to the overground walking device. The goal of the training is to get the person walking in the device. At the end of the 6 week out-patient training period, if they can show that they are able to use the device safely and effectively for walking, they can take the device home.

    We debated whether this clinical trial would be so disruptive that only unemployed people would be able to participate in the trial. After much internal discussion and some discussions with people with spinal cord injury, I believe that it is reasonable to expect people to participate in the clinical trial, undergo 6 weeks of intensive outpatient training, go home and do about 3 hours a day of locomotor training, and then continue at one hour a day for the rest fo the time. So, basically, to participate in the clinical trial, people who are employed or going to school would take 3 months leave of absence or vacation. That is one of the reasons why we are aiming to initiate the phase 3 trial in June, July, and August (summer vacation months for most college or graduate school).

    In my opinion, to maximize the likelihood of motor recovery, we need to encourage everybody to try to engage to the same intensity and duration of training and exercise. Note that people who are successful, i.e. who are able to walk and do more, will actually train and exercise more. This will tend to separate out those who recover from those who don't recover. As long as people in all the treatment groups were to work to the same degree and were given the same opportunity, the comparison of recovery amongst the treatment groups would be valid. I have been thinking about how we would monitor the activity of each person. I was thinking of having every person wear a pedometer and then recording the number of steps that the pedometer shows every day. For example, there is a device called "Fitbug" which is a pedometer with a computer program that will upload the daily walking information to a web site. http://www.fitbug.net/v2/about.php

    Another worry that we have is comparing walking recovery of people who have cervical versus thoracic injuries. For participants who have lower thoracic levels and incomplete injuries, walking should be easier. Likewise, people with high quadriplegia would not have the arm strength to be able to do weight support on the walking device. In the main trial for adults, we are planning to test subjects who are C5 to T10 inclusive. Those who are C5 means that they have at least biceps. Those who are T10 should have sensation down to their belly button and many may even have hip flexors (psoas) that would allow them to swing their hips to get stepping. When we randomize the subjects to the treatment groups, we will stratify the subjects by injury level and randomize within each injury level, to insure that we have equal numbers of subjects at each injury level. Finally, we will be comparing change scores, i.e. change from pre-treatment to post-treatment.

    In summary, we are proposing that the main SCINetUSA trial to have the following rehabilition. First, before the treatment phase of the trial, the subjects will be examined three times over a period of 6 months, to ensure that their neurological function is stable (neither improving nor declining) and encouraged to stand an hour a day (in a standing frame). Second, after surgical transplant therapy, the subjects are given a week to recuperate before they start an intensive outpatient locomotor training. If they are not able to step, they will under a 6-week period of treadmill locomotor training to get them to the point where they can walk with a weight-supporting overground locomotor device. They are encouraged to walk up to 3 hours a day for another 6 weeks. After that, they are expected to walk at least an hour per day. We will be monitoring their daily walking with pedometers.

    Wise.
    dr.wise, just one question. you said for people who can step , does that mean stepping without calipers or with calipers.
    thanks

  3. #13
    Senior Member cypresss's Avatar
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    1) shotglass5050 many thx for your question. I'm into the same dilemma from time to time.
    2) Dr Wise, thx for your replay. I'll consider your advice.

    Quote Originally Posted by Wise Young View Post
    I have been thinking about how we would monitor the activity of each person. I was thinking of having every person wear a pedometer and then recording the number of steps that the pedometer shows every day.
    I know that Nike has a similar product. The shoes are named Nike+. It's about Nike+ iPod sensor(29$) or Nike+ sportband(59$) which works without iPods.



    ps: Nike will not be interested to put some money in this trial? Can anyone from here ask them?
    Last edited by cypresss; 07-06-2009 at 04:31 PM.
    This signature left intentionally blank.

  4. #14
    Quote Originally Posted by lakboy View Post
    dr.wise, just one question. you said for people who can step , does that mean stepping without calipers or with calipers.
    thanks
    Lakboy, we do not require stepping by the people. We are considering requiring all subjects to be able to do weight-bearing (stand) with their feet for at least one hour per day when they start the treatment phase of the trial. This is because we do not want people to waste the 6 weeks of intensive rehabilitation that we will be providing to the them after the treatment. During those 6 weeks, we want to train them to start stepping and eventually to start overground weight-supported locomotion with a rolling device.

    Not all subjects will be able to do stepping by the end of 6 weeks training. We are of course hypothesizing that those subjects that received treatment will be able to do so better than those that did not. This is what the trial will be testing. It is possible that all subjects recover some stepping and improve as a result of the training. It is also possible that none of the subjects recover any stepping and do not shown any locomotor improvement (measured by the WISCI score) as a result of the training. ]

    Regarding whether an orthosis, such as calipers, will be used will depend on the judgment of the physiatrist who is running the training program. Some fo the subjects, particularly if they use calipers, will use them. Most subjects, I would imagine will need an orthosis for their foot drop. In China, they use an elastic band that is stretched in a figure-8 format around the ankle and the foot, to prevent footdrop. This seems to be quite effective. One concern that some of our therapists have is that some people may be overextending their knees when walking. If so, we may have to use a knee orthosis that prevents overextension of the knee.

    Wise.

    The so-called "maximum WISCI" score is obtained by choosing a particular level that the therapist believes the subject is able to achieve and then seeing whether the subject is able to achieve it and hopefully surpass that level. One worry that we have is that the intensity and type of training may differ significantly amongst centers. To standardize, we will try to require

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