Abstract:
A therapeutic mobilization device is disclosed. The device includes a flexion assembly, a pro/supination assembly and a valgus carrying angle compensation device. The flexion assembly has an arm attachment assembly and an elbow actuator and the elbow actuator defines and axes of rotation. The pro/supination assembly is attached to flexion assembly and has a distal forearm attachment assembly and a pro/supination actuator operably connected thereto. The valgus carrying angle compensation device is operably attached to the flexion assembly and the pro/supination assembly. Preferably the pro/supination assembly is slidably mounted on a housing shaft whereby during flexion the pro/supination assembly is free to move along the housing shaft. Further, preferably the arm attachment assembly includes an attachment ring and an adjustable clamp pivotally attached thereto whereby the attachment ring defines a pro/supination axis and the adjustable clamp pivots orthogonally to the pro/supination axis.

Description:
CROSS REFERENCE TO RELATED PATENT APPLICATION 
   This patent application is a continuation application of U.S. patent application, Ser. No. 09/689,812 filed on Oct. 13, 2000 now abandoned entitled COMBINATION PRO/SUPINATION AND FLEXION THERAPEUTIC DEVICES with the same inventors, which is related to U.S. Provisional Patent Application, Ser. No. 60/189,051 filed on Mar. 14, 2000 entitled A COMBINATION PRO/SUPINATION AND FLEXION THERAPEUTIC MOBILIZATION DEVICE. 

   FIELD OF THE INVENTION 
   This invention relates to therapeutic mobilization and splinting devices and in particular a combination pro/supination and flexion device. 
   BACKGROUND OF THE INVENTION 
   In recent years it has become evident that the rehabilitation and treatment of injured joints and surrounding soft tissue can be expedited by use of continuous passive motion (CPM) static and dynamic serial splinting of the involved joint and surrounding soft tissue. CPM and splinting entails moving the joint via its related limbs through a passive controlled range of motion without requiring any muscle coordination. Active motion is also beneficial to the injured joint, however muscle fatigue limits the length of time the patient can maintain motion or positioning, therefore a device that provides continues passive motion to the joint is essential to maximize rehabilitation results. Numerous studies have proven the clinical efficacy of CPM or splinting to accelerate healing and maintain a range of motion. Static Progressive Splinting (SPS) and Dynamic Splinting (DS) are accepted and effective treatment modalities for the management and modelling of soft tissue surrounding articulations. Both SPS and DS have been proven efficacious and are supported by clinical studies. CPM, SPS and DS are integral components of a successful therapy protocol. 
   The successful rehabilitation of elbow and forearm injuries is complex, time consuming and often challenging due to the mobility, complex geometry and high stresses in and around the joint. 
   SUMMARY OF THE INVENTION 
   The therapeutic mobilization device of the present invention includes a flexion assembly, a pro/supination assembly and a valgus carrying angle compensation device. The flexion assembly has an arm attachment assembly and an elbow actuator and the elbow actuator defines and axes of rotation. The pro/supination assembly is attached to flexion assembly and has a distal forearm attachment assembly and a pro/supination actuator operably connected thereto. The valgus carrying angle compensation device is operably attached to the flexion assembly and the pro/supination assembly. 
   In another aspect of the present invention the therapeutic mobilization device includes an arm attachment assembly, a distal forearm attachment assembly, and elbow actuator and a valgus carrying angle compensation device. The compensation device is connected between the arm attachment assembly and the distal forearm attachment assembly. The elbow actuator is operably connected to the arm attachment assembly and the distal forearm attachment assembly whereby movement of the actuator causes the user&#39;s elbow to move through flexion. 
   In a further aspect of the invention the therapeutic mobilization device includes an arm attachment assembly, a distal forearm attachment assembly and an elbow actuator. The distal forearm attachment assembly includes a housing shaft and an adjustable clamping mechanism slidably mounted on the housing shaft. The elbow actuator is operably connected to the arm attachment assembly and the housing ring whereby movement of the actuator causes the user&#39;s elbow to move through flexion and the adjustable clamping mechanism is free to move along the housing shaft. 
   In a still further aspect of the invention a therapeutic mobilization device includes a pro/supination actuator and a pro/supination assembly. The pro/supination assembly includes a pro/supination housing, an attachment ring rotatably attached to the housing and a distal forearm attachment assembly attached thereto. A belt is attached to the attachment ring and to the pro/supination actuator whereby actuation of the pro/supination actuator causes the belt to move the attachment ring in pronation and supination. 
   It is an object of the present invention to provide continuous passive motion and/or electronically controlled progressive splinting device. The device will have two operating modes. The first and default-operating mode may be CPM. CPM typically involves defining a range of motion (ROM) within which a device operates. A pause can be added at the end of the direction of travel prior to the device returning to the other programmed extreme of motion. This operational mode promotes the maintenance of a joint&#39;s ROM. CPM devices are typically configured with a Reverse On Load (ROL) safety feature. The ROL is the level of force or resistance required to reverse the direction of travel or rotation of a CPM device. 
   The device may be suitable for bed, chair and ambulatory use configurations. The device may be symmetrical and ambidextrous. The device provides a full range of variable elbow flexion. The device also provides a full range of variable pronation and supination motion for the forearm. These motions are available in a synchronized motion, independently or in a serial motion. If pro/supination serial motion is chosen, preferably pro/supination will occur at 90 degrees of elbow flexion or as close thereto as possible. This is to limit stress on the joints. Preferably the device is controlled by a hand-held user interface which allows the operator to adjust the speed of travel (CPM mode only), range of motion, pause time at end of cycle and reverse on load. Preferably the device includes a means to electronically lock the patient settings while still allowing the patient to adjust the speed. 
   The orthosis of the device is configured to provide anatomical elbow flexion and forearm pro/supination. The orthosis also compensates for the valgus carrying angle. The valgus carrying angle is the result of the lateral migration of the distal radius and ulna relative to the distal humerus as the forearm pro/supinates. The orthosis may also compensates for the anthropometric variances between patients. This is achieved by accommodating differences in arm circumference, length and anatomical axis relative to the exterior surfaces of the arm. The device integrates a novel arrangement of strain gauges to monitor the amount of force in flexion and torque in pro/supination the device is delivering to the involved limb. 
   The invention relates to continuous passive motion (CPM) and progressive splinting devices for the synovial joints and surrounding soft tissue of the human body. The device forming the present invention comprises proximal and distal humerus supports. The humerus supports are allowed to move telescopically relative to each other, where the distal humerus support is suitably fixed to the chassis of the device. The device also comprises a distal radius and ulna support. The radius and ulna supports move in rotation relative to the humerus supports to provide pro/supination. The distal radius and ulna support also moves in a planer motion relative to the humerus supports to provide elbow flexion. The device includes two microprocessor controlled electric actuators. The actuators are located at the elbow and distal forearm. The actuators are suitably fixed to the orthosis and provide rotational motion concentric with the elbow and forearm&#39;s anatomic axis. The elbow actuator is a simple pivot actuator whereby a mechanical pivot is concentric with the device&#39;s elbow anatomical axis. 
   In typical CPM mode the ROM is defined and the device operates through a consistent defined range. An alternate configuration of elbow anatomical axis compensation includes two semicircular shapes slidably mounted to each other. This configuration can achieve similar results in providing one adjustment to compensate for circumference and position of the elbow&#39;s anatomic axis relative to the upper arm. 
   Further features of the invention will be described or will become apparent in the course of the following detailed description. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention will now be described by way of example only, with reference to the accompanying drawings, in which: 
       FIG. 1  is a perspective view the combination pro/supination and flexion therapeutic mobilization device constructed in accordance with the present invention; 
       FIG. 2  is an exploded perspective view of the flexion assembly and the pivot of the combination pro/supination and flexion therapeutic mobilization device; 
       FIG. 3  is a side view of the combination pro-supination and flexion therapeutic mobilization device; 
       FIG. 4  is a side view of the combination pro-supination and flexion therapeutic mobilization device showing the device in two positions for the device; 
       FIG. 5  is an enlarged front view of the combination pro-supination and flexion therapeutic mobilization device with a portion broken away; 
       FIG. 6  is an enlarged front view of the combination pro-supination and flexion therapeutic mobilization device with a portion broken away showing the device in a different position from the position shown in  FIG. 5 ; 
       FIG. 7  is a perspective view of the combination pro-supination and flexion therapeutic mobilization device showing the device attached to a stand; 
       FIG. 8  is a perspective lateral view of an alternate embodiment of the combination pro/supination and flexion therapeutic mobilization device constructed in accordance with the present invention; 
       FIG. 9  is a perspective medial view of the combination pro/supination and flexion therapeutic mobilization device shown in  FIG. 8 ; and 
       FIG. 10  is an enlarged perspective view of the valgus pivot of the combination pro/supination flexion therapeutic mobilization device shown in  FIGS. 8 and 9 . 
       FIG. 11  is an enlarged perspective view of the humerus support and flexion actuator assembly of the therapeutic mobilization device shown in  FIGS. 8–10 ; 
       FIG. 12  is an enlarged perspective view of the humerus support of the therapeutic mobilization device shown in  FIGS. 8–11 ; 
       FIG. 13  is a perspective view of the mounting stand for use in association with the therapeutic mobilization device of the present invention; 
       FIG. 14  is a perspective view of a flexion therapeutic mobilization device constructed in accordance with the present invention; and 
       FIG. 15  is a perspective view of a pro/supination mobilization device constructed in accordance with the present invention. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Referring to  FIGS. 1 and 3  an elbow and wrist therapeutic mobilization device or pro/supination flexion mobilization device is shown generally at  10 . The device includes an upper arm or humerus support  22 , an elbow or flexion assembly  24  and a wrist or pro/supination assembly  26 . 
   The upper arm or humerus support  22  includes a lower or distal humerus cuff  28  and an upper or proximal humerus cuff  30 . Cuff  30  is slidably mounted along cuff support  32 . A lower cuff strap  34  (shown in  FIG. 3 ) is attached to the lower humerus cuff  28  and an upper cuff humerus strap  36  is attached to the proximal humerus cuff  30 . Straps  34  and  36  use hook and loop type fastener to allow for easy attachment and adjustment. The distance between the lower humerus cuff  28  and the proximal humerus cuff  30  can be adjusted to ensure that device  10  is securely attached to the patient, shown in phantom at  38 . 
   The elbow assembly  24 , as shown in  FIGS. 1 and 2 , includes first and second elbow actuators  40  and  42  respectively, spaced apart top and bottom orthosis rods  44  and  46  respectively and barrel nut assembly  48 . Top and bottom orthosis rods  44  and  46  each have a back portion  50  and forwardly and outwardly extending first and second side portions  52  and  54  respectively. The first  40  and second  42  elbow actuators are slidably mounted on the side portions  52 ,  54  of the top  44  and  46  bottom orthosis rods. One of the first  40  and second  42  elbow actuators is a drive flexion elbow actuator and the other may be an idler elbow actuator. Elbow actuators  40 ,  42  each have an elbow axis of rotation  56  that is co-linear. Barrel nut assembly  48  is attached with threaded type connections at one end to the first elbow actuator  40  and at the other end to the second elbow actuator  42 . Rotation of the nut  58  in one direction causes the elbow actuators  40  and  42  to move toward each other and rotation in the other direction causes them to move away from each other. As the elbow actuators  40 ,  42  move relative to each other the elbow axis of rotation  56  remains co-linear. 
   The elbow assembly  24  is arranged such that it can easily be adjusted to accommodate patients with different sized elbows and different position of the elbow axis or rotation relative to the humerus support  22 . As the first and second elbow actuators  40  and  42  slidably move along top  44  and bottom  46  orthosis rods away from each back portion  50  thereof the distance of the elbow axis  56  relative to humerus support  22  proportionately increases and the distance between the first  40  and second  42  elbow actuators increases. Accordingly by adjusting the barrel nut assembly  48  the patient or health care assistant uses one motion and adjustment to accommodate differences in upper arm circumferences and differences in position of the arm elbow anatomic axis relative to the posterior surface of the arm. 
   The first  40  and second  42  actuators have corresponding first  60  and second  62  rotating shafts respectively. Rotating shafts  60  and  62  rotate in a concentric fashion with the elbow axis  56 . First  64  and second  66  drive stays are connected at one end to first  60  and second  62  rotating shafts respectively. At the other end first  64  and second  66  drive stays are connected to valgus pivot  68 . Pro-supination assembly  26  is attached to valgus pivot  68 . 
   Pro-supination assembly  26  includes a pro/supination housing  70 , housing shaft  72 , a ring assembly  74  and a ulna clamping device  76 . Housing shaft  72  includes a pair of parallel rods  73 . Pro/supination housing  70  is slidably mounted to parallel rods  73  so that it can easily move along the rods during use. Rods  73  include a bent portion  75  at the distal end thereof which limits movement of the pro/supination housing  70 . At the other end rods  73  are attached to valgus pivot  68 . 
   Ring assembly  74  has a variable ulna clamp  76  on the inside thereof, as best seen in  FIG. 1 . Padding and soft goods  80  are attached to screw clamps for comfort. Screw clamps  76  are adjustable to compensate for variations in the size of a patient&#39;s distal radius and ulna as well as centering the patient&#39;s limb along the pro/supination axis  82 . The center of ring assembly  74  is concentric with pro/supination axis  82 . The softgoods  80  of the pro/supination assembly  26  are secured to the ulna clamping mechanism  76 . The softgoods  80  provide a comfortable patient interface and drive point for the distal radius and ulna. The softgoods  80  can accommodate a range of wrist flexion and deviation positions when secured to the pro/supination drive. 
   Ring assembly  74  is slidably mounted in pro/supination housing  70 . An external belt  84  moves the ring in a rotational fashion relative to pro/supination housing  70 . Referring to  FIGS. 5 and 6 , pro/supination housing  70  includes a pro/supination actuator  86  which drives the belt  84  which in turn drives the ring assembly  74 . Idlers  78  help to keep belt  84  taut and in position. A ring channel  88  is formed in the pro/supination housing  70  so that the ring assembly rotates around its center which is concentric with the pro/supination axis  82 . The ring assembly  74  is sized to allow the distal portion of the forearm of the patient to be positioned and secured in the center of the ring assembly  74 . The pro/supination axis  82  is arranged such that it is concentric with the anatomic axis of the patient&#39;s forearm. The pro/supination housing  70  is slidably mounted in a radial fashion relative to the elbow axis  56 . The ulna clamp device  76  secures the patient&#39;s distal radius and ulna too effectively transfer flexion and pro/supination from the humerus to the forearm. Preferably the ulna clamp device  76  is secured against the patient&#39;s distal radius and ulna wrist bone however it will be appreciated by those skilled in the art that ulna clamps could be secured to the patient anywhere along the ulna. 
   As shown in  FIG. 2  valgus pivot  68  includes a top disc  90 , a middle disc  92 , a bottom disc  94  and a center pin  96  which holds them in pivotal arrangement. Top disc  90  is attached to first drive stay  64 . Middle disc  92  is attached to second drive stay  66 . Bottom disc  94  is attached to housing rods  73 . Each of the discs can move independently of the others thus stays  64  and  66  and housing rods  73  can rotate relative to each other. Pivot  68  compensates for the variations in valgus carrying angle and the adjustable distance between the elbow actuators. Thus the valgus carrying angle is compensated for in a pivot  68  located between the elbow actuator&#39;s  40 ,  42  drive stays  64 ,  66  and the rods  73  that allow the pro/supination drive to slidably move. 
   A mounting feature on the orthosis allows the device to be secured to a bed, chair or ambulatory feature. As shown in  FIGS. 7 ,  8 ,  9  and  13 , devices  10  and  120  (described below) may be mounted on a stand  100 . Referring to  FIG. 13  a mounting receptacle  111  is attached to a mounting post  113 . Mounting post  113  is telescopic and its height is adjusted by adjusting knob  102 . 
   The anatomical features are to compensate and align the orthosis&#39; actuators with the anatomic axis of the elbow and forearm. These features serve to minimize stress on the joint and surrounding soft tissue as the device moves through its range of motion. 
   Device  10  includes a patient controller  104 . Device  10  is electrically connected to the patient controller  104  by cord set  106 . Switch  108  on patient controller  104  turns the device  10  off and on. Patient controller  104  is connected to power supply  112  via cable  110 . Patient controller  104  contains rechargeable batteries and can supply power to device  10  with or without being connected to a wall outlet. 
   With all of the therapeutic motion and splint devices it is important to align the device appropriately. 
   Referring to  FIGS. 9 through 12  an alternate embodiment of an elbow and forearm therapeutic mobilization device or pro/supination flexion mobilization device is shown generally at  120 . Only those elements different from those described above will be described herein in detail. Those elements which are the same will be referred to by the same number. 
   The mobilization device  120  includes an upper arm or humerus support  22 , an elbow or flexion actuator assembly  122  and a wrist or pro/supination assembly  26 . 
   The upper arm or humerus support  22  includes a lower or distal humerus cuff  28  and an upper or proximal humerus cuff  30 . Proximal humerus cuff  30  is slidably mounted with respect to humerus support  22  via two parallel rods  32  and secured in position by lock knobs  124 . A distal cuff strap  36  is attached to the distal humerus cuff  28  and a proximal cuff humerus strap  34  is attached to the proximal humerus cuff  30 . Straps  34  and  36  use hook and loop type fastener in conjunction with buckles  126  and  128  to allow for easy attachment and adjustment. The distance between the distal humerus cuff  28  and the proximal humerus cuff  30  can be adjusted to ensure that mobilization device  120  is securely attached to the patient. 
   An L-shaped member  146  attaches humerus support  22  to elbow actuator assembly  122 . The orientation of the humerus support  22  can be changed by depressing a button  148  that engages one of a pair of aperture  150  and then rotating humerus support  22  until it engages the other of aperture  150 . A mounting post  152  is adapted to engage mounting receptacle  111 . Mounting post  152  includes a quick release button  154  for disengaging device  120  from stand  100 . Elbow actuator assembly  122  is mounted on L-shaped member  146  with a mount  156 . Mount  156  includes electronic switches  158 . 
   The elbow actuator assembly  122  includes an orthosis stay  130  and is pivotally connected to actuator  122  at  132  and pivots around the elbow flexion rotational axis  134  as best seen in  FIG. 10 . Pivot point  132  of orthosis stay  130  is concentric with the elbow pivot axis  134 . Orthosis stay  130  is pivotally connected at one end to flexion/elbow actuator assembly  122 . The distal end of orthosis stay  130  is connected to valgus pivot  68  as best seen in  FIG. 10 . Pro/supination assembly  26  is attached to valgus pivot  68  via rods  73 . Orthosis stay  130  is attached to valgus pivot  68  by a plurality of fasteners  140 . A retractable button  142  engages one of the two opposing positioning aperture  144  in orthosis stay  130 . The aperture  144  that is engaged determines the orientation of the rods  73  relative to the orthosis stay  130 . 
   Pro/supination assembly  26  includes a pro/supination housing  70 , a ring assembly  74 , a variable distal forearm clamping device  76  and pair of parallel rods  73 . Pro/supination actuator housing  70  is slidably mounted to parallel rods  73  and is limited in distal sliding range by end stop  136 . An elastomeric tether  138  is attached between end stop  136  and pro/supination assembly  26 . Elastomeric tether  138  compensates for the weight of the pro/supination assembly  26  and reduces the stress on the users elbow that would be exerted on the patient from the pro/supination assembly. 
   Ring assembly  74  has a variable distal forearm clamp  76  on the inside thereof, as best seen in  FIG. 9 . Padding and soft goods  80  are pivotally attached to screw clamps for comfort. Padding and soft goods  80  are attached such that they can pivot around an axis that is orthogonal to pro/supination axis  82 . Screw clamps  76  are adjustable to compensate for variations in the size of a patient&#39;s distal radius and ulna as well as centering the patient&#39;s limb along the pro/supination axis  82 . The center of ring assembly  74  is concentric with pro/supination axis  82 . The softgoods  80  provide a comfortable patient interface and drive point for the distal radius and ulna. The softgoods  80  can accommodate a range of wrist flexion and deviation positions when secured to the pro/supination assembly  26 . 
   Ring assembly  74  is slidably mounted in pro/supination actuator housing  70 . An external belt  84  moves the ring in a rotational fashion relative to pro/supination actuator housing  70 . The pro/supination axis  82  is arranged such that it is concentric with the anatomic axis of the patient&#39;s forearm when positioned in the device  120 . The pro/supination housing  70  is slidably mounted in a radial fashion relative to the valgus pivot axis  83 ,  134 . The forearm clamp assembly  76  and softgoods  80  secure the patient&#39;s distal radius and ulna to effectively transfer flexion and pro/supination from the humerus to the forearm. Preferably the forearm clamp assembly  76  and softgoods  80  are secured against the patient&#39;s distal ulna and radius. However it will be appreciated by those skilled in the art that ulna clamps  76  could be secured to the patient anywhere along the ulna. 
   Mobilization device  120  may be mounted on a stand  100  and the height is adjustable with adjusting knob  102 . Mobilization device  120  includes a patient controller  104 . Device  120  is electrically connected to the patient controller  104  by cord set  106 . Switch  108  on patient controller  104  turns the device  120  off and on. Patient controller  104  is connected to power supply  112  via cable  110 . Patient controller  104  contains rechargeable batteries and can supply power to device  120  with or without being connected to a wall outlet. 
   Valgus pivot  68  compensates for the variations in carrying angle. The carrying angle is compensated for in a valgus pivot  68  located between the elbow actuator&#39;s  122 , orthosis stay  130 , and the pro/supination assembly slidably mounted on rods  73 . The valgus pivot  68  compensates for misalignment of the patient in the device when it is first attached and during treatment. It minimizes the stresses that are caused by misalignment of the device. The sliding of the pro/supination assembly helps to compensate for the distraction and compression forces during use. 
   The mobilization device  120  is arranged such that only one adjustment is required to accommodate a range of patients with different sized arms and forearms. Only the proximal humerus cuff  30  is adjusted between patient sizes to accommodate differences in upper arm circumferences and differences in position of the arm&#39;s elbow anatomic axis relative to the posterior surface of the arm. This is accomplished by the pro/supination assembly  26  being slidably mounted along rods  73  and having a pivot at the ulna clamping device  76 . The anatomical features are to compensate for and align the orthosis&#39; actuators with the anatomic axis of the elbow and forearm and these features serve to minimise stress on the joint and surrounding soft tissue as the device moves through its range of motion. 
   Mobilization device  120  is designed to easily be adjusted. The device  120  is asymmetrical with the flexion actuator assembly  122  being positioned on the lateral side of the treated arm to minimise abduction while being treated and improve patient comfort. The device  120  can be converted to treat the left and right arm by unlocking and pivoting three components once it is removed from stand  100 . To convert the device from left to right the user unlocks and pivots the humerus support  22 , the flexion/elbow actuator assembly  122  and valgus pivot  68 . 
   In use mobilization devices  10  and  120  are suitable for bed, chair and ambulatory use configurations. The devices  10  and  120  are symmetrical and ambidextrous. Each device  10 ,  120  offers a full range of variable elbow flexion. Each device  10 ,  120  also offer a full range of variable pronation and supination motion for the forearm. These motions are available in a synchronized motion, independently or in a serial motion. If pro/supination is programmed in a serial motion, preferably pro/supination will occur at 90 degrees of elbow flexion or as close thereto as possible. This is to limit stress on the joints. The device may be controlled by a hand held user interface allowing the operator to adjust the speed of travel (CPM mode only), range of motion, pause time at end of cycle and reverse on load. The device may have a means to electronically lock the patient settings while still allowing the patient to adjust the speed. The orthosis of the device is configured to provide anatomical elbow flexion and forearm pro/supination. The orthosis also compensates for the valgus carrying angle. The valgus carrying angle is the result of the lateral migration of the distal radius and ulna relative to the distal humerus as the forearm supinates. The orthosis also compensates for the anthropometric variances between patients. This is achieved by accommodating differences in arm circumference, length and anatomical axis relative to the exterior surfaces of the arm. The device integrates a novel arrangement of strain gauges to monitor the amount of force in flexion and torque in pro/supination the device is delivering to the involved limb. The anatomical features are to compensate for and align the orthosis&#39; actuators with the anatomic axis of the elbow and forearm. These features serve to minimize stress on the joint and surrounding soft tissue as the device is moved or is positioned through its range of motion. 
   Referring to  FIG. 14  another alternative embodiment of the present invention is shown generally at  160 . Device  160  is solely a flexion device that is similar to device  120  but it does not include a pro/supination assembly. Rather than a pro/supination assembly, device  160  includes an arm support  162 . Arm support is slideably mounted on rods  73 . Arm support has a support ring  168  attached to a housing  166 . Soft goods  80  are pivotally attached to support ring  168  and can rotate around axis  82 . The remainder of device  160  is similar to that described above with regard to device  120 . 
   Similarly it will be appreciated by those skilled in the art that elements of the present invention could be used for a pro/supination only device wherein the flexion actuator was not used or not included in the device at all. As shown in  FIG. 15 , a pro/supination mobilization device  170  may also be constructed in accordance with the present invention. Device  170  includes an upper arm support  22  and a pro/supination assembly  26 . As discussed above the pro/supination assembly  26  includes a pro/supination housing  70  slidably mounted on parallel rods  73 , a ring assembly  74  and a ulna clamping device  76 . Housing shaft  72  includes a pair of parallel rods  73 . Rods  73  have and end stop  136  at one end thereof and at the other end thereof are attached to valgus pivot  68  having a valgus pivot axis  83 . 
   Ring assembly  74  has a variable ulna clamp  76  on the inside thereof. Padding and soft goods  80  are attached to screw clamps for comfort. The center of ring assembly  74  is concentric with pro/supination axis  82 . Ring assembly  74  is slidably mounted in pro/supination housing  70 . An external belt  84  moves the ring in a rotational fashion relative to pro/supination housing  70 . 
   The upper arm support  22  includes a lower or distal humerus cuff  28  and an upper or proximal humerus cuff  30 . Cuff  30  is slidably mounted along cuff support  32 . A lower cuff strap  34  is attached to the lower humerus cuff  28  and an upper cuff humerus strap  36  is attached to the proximal humerus cuff  30 . An L-shaped orthosis stay  130  is pivotally connected at one end thereof to an elongate connector  172  and at the other end thereof it is connected to the vulgas pivot  68 . The elongate connector  172  is also attached to the upper arm support  22 . 
   It will be appreciated that the above description related to the invention by way of example only. Many variations on the invention will be obvious to those skilled in the art and such obvious variations are within the scope of the invention as described herein whether or not expressly described.