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Just started participation in Clinical trial for Weight supported treadmill training

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    Just started participation in Clinical trial for Weight supported treadmill training

    My husband, c3/4 incomplete, has been enrolled in a clinical trial that test the effects of weight supported locomotor treadmill training. the two conditions are manual assist and robotic assist. He has been randomized into the robotic assist group. He has just completed the pretesting and will begin the training on Monday. He is currently able to walk but with difficulty and only short distances. He is very short-strided, and since proprioception and balance are poor, has minimal confidence in walking over ground. The training consists of weight-supported treadmill walking at normal walking speeds, or as close as FDA allows in this robotic device. That is one concern I have as it is less than the manual assist condition. It is possible they will receive the go-ahead to raise the speed while we are here. The investigator told me they will utilize the higher speed as soon as it is available.

    Our goal is to get him able to take walks in our neighborhood. I will keep you all updated on his progress. I will only be here with him for a week, then I will return home. It will be the first time he is on his own since his injury in Oct 2003. It will be a challenge on many levels. We are participating in the trial funded by the VA and the link is as follows.
    http://www.clinicaltrials.gov/ct/sho...127439?order=1
    They are still recruiting participants if any one is interested.

    We are hopeful that he will benefit from this training. We aren't expecting miracles, but some improvement would be great. And I am hoping the mental benefit from being independent here will be great as well.

    It didn't start out too great. Gainesville, where the study is being conducted, is a major football town (GO GATORS). It made it impossible to get a hotel room, which we needed as we are from California. Our first choice hotel was booked for all the home games. Bob would have had to move out every other week-end. So we ended up staying at a "bare bones" motel. It is an accessible room, so that is great. But there were many things that he needs that it doesn't have. Lighting... Completely dark at night and lights that cannot be operated by a quad, limited electrical outlets, uneven flooring... the list goes on. So we went to the local hardware store got a bunch of night light solutions, stocked up on food, Got a table for hand exercise and to eat off of (not even a table in the room). No soap, only a dispenser that he cannot operate, so we got that fixed, had to buy a lamp that he could turn on for lighting... and we're good to go.

    I am very nervous that he will be here on his own. He fell three times in the first 24 hours and got scraped up pretty good. But no falls in the last 48 hours and he is excited to be here.

    I am also looking forward to the break from my caregiving duties. He will be here for 12 weeks.

    I will keep you all updated on his progress.

    #2
    Kitti, this is good news! I'm happy to hear Bob has made it to Gainesville. I'm curious about what you say about the FDA speed restrictions on robotic trainers. How fast is that? I have walked in a Lokomat at speeds up to 2.0 mph, as fast as it goes. Is this the fastest they will go in the study? If so, that is definitely fast enough for Bob to get benefit from the training.

    Yeah, they love the Gators down there! I wasn't there during football season so I missed the kind of issues you faced with the hotels. I'm glad you got something worked out.

    Comment


      #3
      The fastest i've went on the autoambulator was 1.8, with the medium stride thats the max the machine is allowed to go. I"m not sure why its like that but it is!
      Goodluck I hope he benefits from it!
      Injured:10-16-04
      C7/C8, T1 incomplete;


      For stalkers convenience:
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        #4
        Hi Bruce and all.
        I have now returned from Florida, leaving Bob there. It is exceedingly lonely here. I found out that it is not an FDA restriction, but rather an additional module that they have to purchase, which by the way, they are in the process of doing.

        Bob is doing very well in the study. He was up to 30 minutes in the first few days. It was a surreal experience to see him walking normally again. I hope it transfers to the real world.

        I am attaching a picture. He will be there till about mid December. They are really a great group of people, and I feel pretty comfortable with him being there alone.

        Comment


          #5
          Best possible use of time imo. Good work getting him there!
          Blog:
          Does This Wheelchair Make My Ass Look Fat?

          Comment


            #6
            Kitti, this is great! The picture is cool. I agree that the people there are wonderful. Andrea Behrman and the others there have done a remarkable job assembling and teaching the folks that do these clinical trials. Bob is in good hands!

            Comment


              #7
              The locomat seems so much better than the autoambulator, just from that picture the gait looks great and with the autoambulator it looks not so natural.

              Keep up the good work@
              Injured:10-16-04
              C7/C8, T1 incomplete;


              For stalkers convenience:
              Blog:
              http://www.ordealsonwheels.com/
              Facebook:
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              Progress:
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              My drawings:
              http://kanvases.com/sites/corysanchez/home

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                #8
                It was really unbelievable when they first started him walking. It looked so natural, it is easy to forget that the machine is doing the walking. He has now progressed to less machine driven. There are various ways to manipulate the device including how much it is moving the patient, and how much the patient is moving it. They are working now on his arm swing. It is a little difficult in the machine, so I am not sure how they are doing it. He is walking 30 minutes a day at 3.2 km. He has always been prone to exagerration about his recovery, so I don't know how much his overground walking is improving, but I do know that he is walking some of the way home. Probably 1/4 mile.

                I am anxious to see how he is doing, but he prefers that I not come back there. We will see.

                Thanks for all your support. Wednesday is the 3 year anniversary of Bob's accident. I can't believe it has been so long.

                Comment


                  #9
                  Kitti,
                  Question for you: This gait trainer, is it a full body weight support system? How long has your husband been doing the training, and how often? I have just purchased a body weight support system from Robomedica, (California) and it will be ready to use on our clients by the end of this year. I am really excited about it because I have done extensive research on gait training with a person's full body weight going into the ground and I am a firm believer this is the way to go. Will you please, (provided you have some extra time) e-mail me with your husbands results? Karchie11@yahoo.com Thank you!

                  Comment


                    #10
                    Karchie, I really like the system you have purchased! I think this will be a great addition to your tool box. Hope all is well.
                    Wildwilly
                    “As the cast of villains in SCI is vast and collaborative, so too must be the chorus of hero's that rise to meet them” Ramer et al 2005

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                      #11
                      Thanks WildWilly! We are pretty excited about it as well. Hopefully all will be up and running by the middle of December.....I will keep you up to date!

                      Comment


                        #12
                        Hi Karchie,
                        The Lokomat is a full weight support system. They can vary the amount of weight they support, for example Bob started with 70% of his weight, now he is at 80%. They are following a particular protocol as this is a clinical trial. They do vary between patients the amount of support based upon the clinical assessment of what is needed.

                        He is on the machine 5xs per week 35 minutes a day. He will be doing it for 9 weeks.

                        I will keep you posted on the results. They test him and data collect every Weds. but they do not analyze the data until the end. The PT told me however, that they are seeing improvements in his walking everyweek during the testing. The testing is full body weight on a treadmill with harness only for safety.

                        We hope for the best. Bob tells me that he is walking home part way from the hospital. He is living about a 1/2 mile away. His goal is to walk to and from the hospital. He has only been undergoing the training for 3 weeks. He is a tough determined guy. I think he will make it. I asked him how he is doing. He thinks his walking is improving, but I don't think it is getting any easier. This life certainly is a struggle.
                        Thanks for your responses.

                        Comment


                          #13
                          Thanks for the update. I will keep looking to see how Bob is doing.....determination can go a long way!!!

                          Comment


                            #14
                            Karchie, I am a big fan of Robomedica and think very highly of their equipment. I was in a clinical trial at the U of Florida in 2004 with the same folks Kitti's husband Bob is training with. They trained me on their Robomedica and it works very well .. the compressed air system provides excellent floating body weight support, and they have good seating systems for the leg trainers. When I was there they had just got the Lokomat that Bob is using. I got to try it and was impressed. It is capable of full body weight support, in act they would start me "air walking" and then lower me onto the treadmill once everything was going. It was a strange sensation to be sure.

                            Back to Robomedica: Andrea Behrman from UF also helped Robomedica develop their training programs. She has done a remarkable job understanding how to do this, and how to train others to do it. Wise Young posted about a paper she and a couple of the folks in her lab wrote here (in case you missed it): /forum/showthread.php?t=70385

                            Kitti, I'm pleased to hear that things are going well for Bob. His grit will help him get as much as he can. I'm impressed that, after his training, he can walk even partway back to where he's staying. I would usually be so pooped that I could hardly walk back to my car sometimes.

                            I found that it took a while after the training was over to realize the full benefits of it. What I got was the ability to walk faster and with better mechanics. I can walk farther too. I hope Bob continues to improve.

                            Comment


                              #15
                              Thanks Bruce! I have printed the article and posted it on my office door for the clients to read. I have been studying gait patterns for many years and got into contact with Alan Olsen about three years ago. I've kept him on a close radar to keep me on top of my initial promise to get the machine for my clients! We should have everything up and running by the middle of December. To say the least, we are all very excited! Bruce, are you from the Seattle area and did you work out at Next Steps with Al? I remember, somewhat, of Al and Sharon talking about a "Bruce", and I believe I just made the connection. Alan Olsen also has talked about you......I think it is you.

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