Abstract:
A functional electrical stimulation step and stand system comprising two footplates (left and right) connected to a primary drive motor that cause the footplates to move in a reciprocal motion. The footplates are further connected to corresponding servos, which allow for control of the movement of the footplate with respect to an axis. System comprises an electrical stimulation control unit. The stimulation step and stand system further comprises a control unit that has electrical stimulation leads connected to electrode that deliver an electrical impulse to a patient&#39;s muscles. In a further embodiment, the control unit has one or more wireless stimulators.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a Continuation of U.S. patent application Ser. No. 13/219,641, filed Aug. 27, 2011, the specification of which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to a training device for rehabilitation of individuals suffering from neurological injuries. More particularly, the present invention relates to a device that utilizes both mechanical and electrical stimulation of individual&#39;s muscles. 
         [0004]    2. Description of the Background 
         [0005]    The recovery of walking is one of the main goals of patients after a neurological impairment (including stroke, multiple sclerosis, cerebral palsy and spinal cord injury (SCI)) as limitations in mobility can adversely affect most activities of daily living. Following a neurological injury, there is often impaired control of balance, paralysis, or weakness of lower extremity muscles including commonly those that activate the ankle This often has a substantial adverse impact on walking. Specifically, individuals may suffer difficulties supporting their body weight during the stance phase, or shifting weight during the transition to swing, or lifting their foot for toe clearance during the swing phase due to the weakness associated with the injury. Gait training can be done
       i. with therapist-assisted over ground ambulation (with or without assistive device)   ii. in a Body Weight Supported Treadmill Training (BWSTT) environment, where assistance for the movement of legs and the pelvis is provided manually by a therapist or   iii. by a robotic device (Lokomat, Auto-Ambulator or Gait Trainer), or in water (weight supported environment, with or without a treadmill).
 
Over ground gait training (with or without a Functional Electrical Stimulation (FES) orthosis) can only be used for individuals with already able to support body weight in an upright position.
       
 
         [0009]    BWSTT, robotic device gait training and aquatherapy gait training (training in water) can potentially be used to enhance loco-motor abilities in neurologically impaired individuals, as lack of trunk balance and ability to bear weight in an upright position are replaced by the supporting abilities of the device or environment used (harness, exoskeleton or water). But they are not typically used in clinical practice to aid in locomotor training in individuals with motor complete impairments as this training would need specialized, center based, expensive environment (i.e. therapeutic pool, robotic exoskeleton) or is very labor intensive (sometimes requiring 2-3 therapists&#39; sustained effort over long periods of time). 
         [0010]    BWSTT with manual or robotic assistance of the legs and the pelvis has been used as a promising rehabilitation method designed to improve motor function and ambulation in people with SCI (Behrman and Harkema 2000; Dietz et al. 1995;Wernig and Muller 1992; Wirz et al. 2005; Dobkin et al. 2006; Field-Fote et al. 2005). However, while BWSTT has been shown to provide improvements in locomotor ability, motor function, and balance for some patients, the current technology used to assist with the training is typically very expensive, requires trained therapists for utilization and can only be used in a rehabilitation center. Several robotic BWSTT systems have been developed for automating locomotor training, including the Lokomat (Colomboet al. 2000) and Gait Trainer (GT) (Hesse and Uhlenbrock 2000). 
         [0011]    The Lokomat is a motorized exoskeleton that drives hip and knee motion with fixed trajectory using four DC motors (Colombo et al. 2000). One limitation is that it is difficult to back drive the Lokomat because it uses high advantage, ball screw actuator. The GT rigidly drives the patient&#39;s feet through a stepping motion using a crank-and-rocker mechanism attached to foot platforms (Hesse and Uhlenbrock 2000). These robotic systems have their basic design goal to assist patients in producing correctly shaped and timed locomotor movements. This approach is effective in reducing therapist labor in locomotor training and increasing the total duration of training, but shows relatively limited functional gains for some patients (Wirz et al. 2005; Field-Fote et al. 2005). For instance, only 0.11 m/s gait speed improvement is obtained following prolonged training using the Lokomat (Wirz et al. 2005). 
         [0012]    FES has been previously used to enhance the quality of gait training whether as an assistive device (FES orthosis for foot drop) or to enhance muscle strength and improve cardiovascular resistance (FES ergometer), thus decreasing gait induced fatigue. FES has also been used extensively in the rehabilitation of individuals with SCI to:
       i. improve muscle mass and strength (Frotzler A, Coupaud S, Perret C, Kakebeeke T H, Hunt K J, Eser P. Effect of detraining on bone and muscle tissue in subjects with chronic spinal cord injury after a period of electrically-stimulated cycling: a small cohort study. Swiss Paraplegic Research, Nottwil, Switzerland; Thomas Mohr, Jesper L Andersen, Fin Biering-Sùrensen, Henrik Galbo, Jens Bangsbo, Aase Wagner and Michael Kjaer. Long term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord (1997) 35, 1±16)   ii. control spasticity (Maria Knikou, PhD, and Bernard A. Conway, PhD. Reflex Effects Of Induced Muscle Contraction In Normal And Spinal Cord Injured Subjects. Muscle Nerve 26: 374-382, 2002; Daly J., et al. Therapeutic neural effects of electrical stimulation. IEEE Trans Rehabil Eng 4:218-230, 1996; Robinson C. J., et al. Spasticity in Spinal-Cord Injured Patients .1. Short-Term Effects of Surface Electrical-Stimulation. Arch Phys Med Rehab 69:598-604, 1988)   iii. improve cardiovascular endurance and respiratory function (Puran D Faghri, Roger M Glaser, Stephen F Figoni. Functional Electrical Stimulation Leg Cycle Ergometer Exercise: Training Effects on Carriorespiratory Responses of Spinal Cord Injured Subjects at Rest and During Submaximal Exercise. Arch Phys Med Rehabil 73:1085-1093)   iv improve bone mass (Belanger M, Stein RB, Wheeler GD, Gordon T, Leduc B. Electrical stimulation: can it increase muscle strength and reverse osteopenia in spinal cord injured individuals? Arch Phys Med Rehabil 2000; 81(8):1090-1098; McDonald J W, Becker D, Sadowsky C L, Jane J A, Sr., Conturo T E, Schultz L M. Late recovery following spinal cord injury. Case report and review of the literature. J Neurosurg 2002; 97(2 Suppl):252-265) and   v. improve body composition (L. Griffin, M. J. Decker, J. Y. Hwang, B. Wang, K. Kitchen, Z. Ding, J. L. Ivy. Functional electrical stimulation cycling improves body composition, metabolic and neural factors in persons with spinal cord injury. J Electromyography and Kinesiol 2008: 1-8).       
 
         [0018]    FES has been postulated to even alter neuronal control, altering central nervous system plasticity and improving functional tasks performance (Richard K. Shields and Shauna Dudley-Javoroski. Musculoskeletal Plasticity After Acute Spinal Cord Injury: Effects of Long-Term Neuromuscular Electrical Stimulation Training J Neurophysiol 95: 2380-2390, 2006). 
         [0019]    Combining gait training with FES activation of selected muscles involved in stepping has been already achieved and there are several commercially available FES driven orthosis for utilization in individuals with SCI, mainly to correct foot drop (Bioness L300, Walk Aid). In addition, in clinical practice, therapists are frequently utilizing hand held triggered neuromuscular electrically stimulated (NMES) devices to aid in foot/toe clearing during the swing phase of the gait when working with individuals with neurologic lower limb weakness. 
       SUMMARY OF THE INVENTION 
       [0020]    One object of the present invention is to provide a functional electrical stimulation step and stand system comprising two footplates (left and right) connected to a primary drive motor that cause the footplates to move in a reciprocal motion. The footplates are further connected to corresponding servos, which allow for control of the movement of the footplate with respect to an axis. The ability to control the movement of the footplate is defined as the firmness of the footplate. 
         [0021]    In a further object of the present invention, the system comprises an control unit that manages a computer and a six channel stimulator. The control unit has electrical stimulation leads that connect to electrodes that deliver an electrical impulse to a patient&#39;s muscles. In a further embodiment, the control unit has one or more wireless stimulators. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The above and other features, aspects, and advantages of the present invention are considered in more detail, in relation to the following description of embodiments thereof shown in the accompanying drawings, in which: 
           [0023]      FIG. 1  is a picture of a device in accordance with one embodiment of the invention. 
           [0024]      FIG. 2  is a graphical representation of a stepper assembly in accordance with one embodiment of the present invention. 
           [0025]      FIG. 3  is a graphical representation of the stepper assembly in the standing position. 
           [0026]      FIG. 4  is a perspective view of the stepper assembly. 
           [0027]      FIG. 5  is a detailed view of the foot plate. 
           [0028]      FIG. 6  is a detailed view of the foot plate with the servo plate removed. 
           [0029]      FIG. 7  is a detailed view of the foot plate showing the servo drive belt. 
           [0030]      FIG. 8  is a graphical representation of the control unit. 
           [0031]      FIG. 9  is a front view of the patient hoist. 
           [0032]      FIG. 10  is a front view of the harness. 
           [0033]      FIG. 11  is a graph showing the displacement of the pedals with and without servo input. 
           [0034]      FIG. 12  is a graph that shows the various positions of the servo can be commanded. 
           [0035]      FIG. 13  is a graph that shows the result of commanding the servo to move the foot plate for a normal gait. 
       
    
    
     DETAILED DESCRIPTION 
       [0036]    The invention summarized above may be better understood by referring to the following description, the accompanying drawings, and the claims listed below. This description of an embodiment, set out below to enable one to practice an implementation of the invention, is not intended to limit the preferred embodiment, but to serve as a particular example thereof. Those skilled in the art should appreciate that they may readily use the conception and specific embodiments disclosed as a basis for modifying or designing other methods and systems for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent assemblies do not depart from the spirit and scope of the invention in its broadest form. 
         [0037]    As shown in  FIG. 1 , one embodiment of the invention is a trainer  100  that combines a robotic device that simulates stepping and standing with FES while the individual  110  is safely supported in a harness  120 . This design has the potential to tap into neuro-plasticity driven loco-motor patterning while increasing muscle strength and cardiovascular endurance and be safely applied in a center or home-based environment. 
         [0038]    The motion of the individual&#39;s feet is controlled by a foot assembly  200  as shown in  FIG. 2 . The foot assembly  200  (also referred to as the stepper assembly) incorporates three motors. The primary drive motor  210  provides for transverse motion of foot plates  220  while a servo  230  built into both the left and right footplate  220  allow the software to independently control the motion of the foot about the ankle in the sagittal plane. This control can either assist the foot movement being evoked volitionally or electrically or it can resist such movement. 
         [0039]    In one further embodiment of the present invention, a stand training mode allows the foot plates to be brought together helping the individual patient to develop standing skills utilizing a combination of electrically evoked peripheral muscle contractions or volitional and or electrically evoked centrally driven muscle contractions. In this mode the footplate servos  230  can be used to induce perturbations, which the individual can train to counteract. 
         [0040]    The motors controlling each footplate  220  can also be commanded to produce a vibration motion of the footplates in the sagittal plane either during standing or stepping motions. This vibration can be used to deliver therapeutic benefits including the reduction of spasticity. FES driven gait training utilizing the training device  100  will be safe for both motor complete and incomplete neurologically impaired individuals. In addition, the training device  100  can increase the walking abilities of individuals with many types of neurological impairments. Given this the training device  100  can be safely used in a home based environment to perform long term gait training in individuals with varying degrees of neurological related paralysis. 
         [0041]    As shown in  FIG. 1 , training device  100  is composed of a stepper assembly  200 , a control unit  130 , and a patient hoist  150  and harness  120 . The stepper assembly  200 , as shown in  FIG. 2 , has a drive motor  210  connected to the drive assembly  250 . The drive assembly  250  is connected to the foot plates  220  by cranks  260  (left and right respectively) through a drive arm  280 . The cranks  220  are connected to the drive arm  280  at different positions  270  and held in place by a magnet. The positions  270  determine the step lengths for the foot plates  220 . In one particular embodiment, the drive arm  280  has three positions  270  resulting in 18″, 15″, and 12″ steps. An additional position  290  brings the footplates  220  together proving a standing position to the individual, as shown in  FIG. 3 . 
         [0042]    As shown in  FIG. 4 , the stepper assembly  200  further comprises an emergency stop  277  that allows a technician to stop the drive assembly  250  from moving the foot plates  220 .  FIG. 5  shows a close up view of the right side foot plate  220  and servo  230 . In  FIG. 6 , the servo cover  600  has been removed and the servo  230  is shown.  FIG. 7  shows a view of the footplate from the opposite side than that shown in  FIG. 6 . The servo  230  motor connects to a drive belt  700  that controls the foot plate  220 . The servo  230  connects to a pulley  745  through the drive belt  700 . When the servo motor actuates the belt  700 , the pulley  745  turns around the axis  730  causing the footplate to rotate about the axis  730 . Left unpowered, each footplate moves through a range of plantar and dorsi flexion movement that is a natural product of the transverse motion. 
         [0043]    In one particular embodiment, the trainer  100  has a control unit  130 , as shown in  FIG. 8 , which includes a computer and a 6 channel stimulator. The stimulator produces the functional electrical stimulation to evoke muscle contractions. The computer controls the operation of the stimulator, the drive motor  210  and the two footplate servos  230 . Software controlling the servo motors which power the left and right footplates can be used to guide a patient&#39;s foot through a normal range of motion in the sagittal plane during stepping training. 
         [0044]    When in use, the trainer  100  can be utilized to track the appropriate travel of the individual&#39;s feet.  FIG. 11  is a graph that shows how the footplate pedal moves with respect to gravity when unpowered (pedal trace) compared with how the ankle of an able bodied individual moves when stepping (target pedal trace) vs. percentage of phase of the gait cycle. 
         [0045]    Furthermore, in  FIG. 12  shows one way in which a footplate servo motor may be commanded to make the footplate&#39;s position coincident with normal gait. For example, commanding the motor to move 2452 positions results in a 1 degree movement of the footplate. Superimposing this motor driven footplate movement with the unpowered footplate movement that arises from the transverse motion brings the footplate motion (corrected pedal trace) coincident with the ankle movement of normal gait (target pedal trace) vs. percent of the gait cycle as shown in  FIG. 13 . 
         [0046]    Producing this normal ankle movement on this trainer  100  is one of the possible uses of the footplate servo motors. In one exemplary embodiment, the motors are also be used to produce vibration while standing or an exaggerated ankle motion for motor skill relearning purposes or a reduced ankle motion to accommodate patients with reduced range of motion in one or both ankle joints. In one exemplary embodiment, software varies the current supplied to each footplate servo which has the effect of varying the firmness of the footplate. Footplate firmness can be varied during a therapy session for example to gradually overcome plantar flexion muscle tone. 
         [0047]    In one embodiment of the present invention, the control unit  130  provides up to 10 channels of electrical. It is contemplated that any number of channels may be utilized to provide electrical stimulation. In one alternative embodiment, the control unit  130  further includes a 6 channel electrical stimulator and a BlueTooth communications link that allows it to control up to four additional single channel stimulators. 
         [0048]    The muscle groups to be stimulated are selected based upon how the patient presents. For example a hemiparetic patient may only require muscles on one side to be electrically stimulated. 
         [0049]    Our invention allows the following muscle groups to be selected for electrical stimulation each either bilaterally or unilaterally:
       Gluteals   Quadriceps   Hamstrings   Gastrocnemius   Anterior tibialis   Erector spinae   Abdominals
 
The electrical stimulation is delivered to each muscle group via adhesive skin surface electrodes at the appropriate time in the gait cycle as determined by the position of drive arms in their circular path.
       
 
         [0057]    A further embodiment of the invention allows the electrical stimulation angles to be adjusted. The following is a table of default angles that can be provided in one particular embodiment of the present invention. The 0 degree position is the left drive arm at top dead center. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
               
               
                 Muscle group 
                 Stimulation on angle 
                 Stimulation off angle 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Left quadriceps 
                 50 
                 285 
               
               
                 Right quadriceps 
                 230 
                 105 
               
               
                 Left hamstring 
                 235 
                 70 
               
               
                 Right hamstring 
                 55 
                 250 
               
               
                 Left gluteal 
                 90 
                 245 
               
               
                 Right gluteal 
                 270 
                 65 
               
               
                 Left gastroc 
                 235 
                 70 
               
               
                 Right gastroc 
                 55 
                 250 
               
               
                 Left anterior tibialis 
                 50 
                 285 
               
               
                 Right tibialis 
                 230 
                 105 
               
               
                 Left abdominal 
                 340 
                 180 
               
               
                 Right abdominal 
                 160 
                 359 
               
               
                 Left erector spinae 
                 190 
                 290 
               
               
                 Right erector spinae 
                 10 
                 110 
               
               
                   
               
             
          
         
       
     
         [0058]    The invention has been described with references to a preferred embodiment. While specific values, relationships, materials and steps have been set forth for purposes of describing concepts of the invention, it will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the basic concepts and operating principles of the invention as broadly described. It should be recognized that, in the light of the above teachings, those skilled in the art can modify those specifics without departing from the invention taught herein. Having now fully set forth the preferred embodiments and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with such underlying concept. It is intended to include all such modifications, alternatives and other embodiments insofar as they come within the scope of the appended claims or equivalents thereof. It should be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein. Consequently, the present embodiments are to be considered in all respects as illustrative and not restrictive.