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                   TheraSuit® 
                    Orthosis 
                  I. 
                    The History and Development of TheraSuit® 
                    Orthosis: 
                  TheraSuit® 
                    , defined by FDA 
                    as a soft, dynamic, proprioceptive orthotic, is a full-featured 
                    dynamic correction clothing. The invention of the Therasuit® 
                    can be tracked 
                    back since the 1960s BC, the United States and the Soviet 
                    Union compete to develop space science and technology (the 
                    so-called Space-Age). The Soviet Union's space science laboratories 
                    found that astronaut's physical and neurological condition 
                    had been changed after staying in a gravity-free environment 
                    for an extended period of time. Without the affect of gravity, 
                    the astronaut's spinal cords had been elongated about 2 inches. 
                    There was no doubt that the astronauts suffered a neurological 
                    change in their body, as well as a musculoskeletal change 
                    of not using their muscles to fight against the gravity in 
                    order to move around for their activities of daily living. 
                    After returning to the earth, the astronauts suffered muscle 
                    atrophy, loss of muscle strength, osteoporosis (bone demineralization), 
                    decreased cardiopulmonary function, reduced joint mobility, 
                    and change in proprioception. 
                  So 
                    the Soviet space scientist designed and developed a fully 
                    functional prototype of the dynamic correction clothing- called 
                    "PENGUIN SUIT". By wearing this "Penguin Suit", 
                    it provided deep compression force on the skin, muscle, and 
                    bone even in weightlessness. So the astronauts would not suffer 
                    from the effects of extended staying in the gravity-free environment. 
                    And the scientists and the rehab-medicine team also developed 
                    a set of intensive training program to restore and build up 
                    the astronauts' physical and sensor-motor function. 
                  In 
                    1971, Professor Siemionowa, the Soviet space medical expert, 
                    improved and modified the "PENGUIN SUIT", called 
                    "ADELI SUIT" which is still used by the astronauts. 
                    The astronauts and children with cerebral palsy, or neuro-muscular 
                    and developmental disorders have the same physical and neurological 
                    changes in decreased range of motion of joint mobility, reduced 
                    muscle strength, and difficulty of movement against the gravity. 
                    At the Pediatric Institute of the Russian Academy of Science, 
                    a team developed and modified the first "Adeli Suit"- 
                    renamed the " LK Adeli 92". This was the early prototype 
                    "suit" developed and used for the various populations 
                    with cerebral palsy or neuro-muscular disorders. They soon 
                    discovered the " LK Adeli 92" work well for the 
                    children with cerebral palsy, and mainly designed for the 
                    functional movement in an upright position liked standing 
                    and walking due to the way of original setting and design 
                    of the bungee cords. The bungee cords provided the resistance 
                    only in the upright position. 
                  In 
                    1994, because of the limitation of the "LK Adeli 92", 
                    an improved "Suit" was re-developed and called "LK 
                    Adeli 94". It consisted of a vest, shorts, headpiece, 
                    knee pieces, padding, and special shoes with hooks for wearing. 
                    In 1997, the trained Poland physical therapist couple, Richard 
                    and Izabela Koscienlny- parents of a disabled child, first 
                    introduced the "Adeli Suit", "Universal Exercise 
                    Unit", and the "Intensive Training Program" 
                    into the United States, and used these devices in pediatric 
                    physical therapy rehabilitation. Later in 2002, further improvement 
                    of the re-designed "Suit" by Richard and Izabela 
                    was named "TheraSuit®". 
                    The further improvement was added in padding for comfort, 
                    Velcro closure for increased efficiency in application, and 
                    covering with variety of hooks in optimal locations for more 
                    options of bungee cord attachments. TheraSuit® 
                    is the only one 
                    of these kind of devices in United States registered with 
                    FDA (defined as a soft, dynamic proprioceptive orthotic) and 
                    meeting all requirements and regulations (U.S. Patent US 7,153,246, 
                    International Patent PCT/US2008/051458). In 2007, Kevin Huang, 
                    PT, MA, , the trained and certified instructor (by TheraSuit® 
                    LLC), first introduced the " TheraSuit®", 
                    "Universal Exercise Unit (UEU)", and "Intensive 
                    Therapy Program" into Taiwan, and used in pediatric physical 
                    therapy rehabilitation. Later in 2009, further registered 
                    and approved with Department of Health in Taiwan, R.O.C. - 
                    "TheraSuit® 
                    Orthosis " 
                    ( DHA04400754801), as well as registered Patent of " 
                    TheraSuit®" 
                    in Taiwan ( Patent # 01337168) and in China ( Patent # 6538085). 
                    
                  II. 
                    The Components of the TheraSuit®: 
                  
                     
                       
                        
                          - Cap
 
                          - Vest
 
                          - Shorts
 
                          - Knee 
                            Pads
 
                          - Shoe 
                            Attachments
 
                          - Elastic 
                            Bands
 
                          - Plastic/Metal 
                            Hooks
 
                          - Arm Attachments
 
                         
                         
                          All the mentioned above elements of the TheraSuit® 
                          are connected with each other through a system of elastic 
                          bands.  
                         
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                  III. 
                    The Concepts of TheraSuit®: 
                     
                  The 
                    TheraSuit®is 
                    defined by FDA as a soft, dynamic, proprioceptive orthosis 
                    constructed of a breathable but highly durable fabric. It 
                    is derived from the space rehabilitation medicine, and is 
                    a safe and effective treatment tool that acts as an external 
                    set of muscles. By way of adjusting the length of the elastic 
                    bands (tension and force adjustment) and the location and 
                    direction of the elastic bands' attachment (three dimensional 
                    correction of posture and movement), the TheraSuit® 
                    provides three 
                    major goals: 1) 
                    to provide support and stability during positioning and posture,2) 
                    to provide dynamic assistance or resistance during muscle 
                    strengthening, and 3) to promote 
                    facilitation or acceleration in functional skill training.The 
                    TheraSuit® 
                    provides proper 
                    and dynamic compression and loading force on the body, skin, 
                    muscles, joints to correct body alignment to as close to normal 
                    as possible in static posture and during dynamic transitions, 
                    and to re-train the central nervous system and to normalize 
                    the muscle tone for the new functional skill learning (below- 
                    picture 2). It also reduces abnormal pathological reflexes, 
                    restores proper physiological synergy movement pattern. All 
                    of the above proper tactile and propriocetive stimulations 
                    normalize afferent vestibular-proprioceptive inputs to the 
                    vestibular system. The vestibular system processes, integrates 
                    all the information afferent from skin, muscles and tendons, 
                    joints and ligaments, etc (below- picture 1). The central 
                    nervous system conducts normal and proper efferent message 
                    to muscles, tendons, and joints for correct posture, proper 
                    transitions, and graded functional skill. It influences muscle 
                    tone, balance, coordination, body awareness and the position 
                    of the body in space. 
                  
                    
                  According 
                    to the "Motor Learning Theory", 
                    the more correct proprioceptive inputs the central nervous 
                    system receives from the joints, ligaments, muscle, tendons, 
                    joint's capsule, etc., the more correct alignment, proper 
                    posture, and graded movement pattern our body can perform. 
                    The vicious cycle can be interrupted, and incorrect information 
                    is replaced by "new" corrected information. A patient 
                    diagnosed with cerebral palsy and other neuro-motor disorders 
                    requires hundred of repetitions of any particular movement. 
                    We believe that as individuals, we all have a "magic" 
                    number. For example, a baby that is trying to push-off the 
                    floor will need to repeat this movement a few hundred times 
                    in order to master it. Another one may need either more or 
                    less repetitions to learn the same skill. For the Cerebral 
                    palsy child, however, this fairly low "magic" number 
                    grows to a thousand or more repetitions to learn and master 
                    new skills. TheraSuit® 
                    worn over a prolonged 
                    time will correct proprioception and accelerate the progress. 
                    The TheraSuit® 
                    can help to practice 
                    the skills and becomes more fluent, and require less and less 
                    effort. Therefore, the TheraSuit® 
                    facilitates the 
                    development of new gross and fine motor skill like sitting 
                    standing, and walking. 
                    
                  
                    
                  EEG 
                    also studies had been done on the brains of children who had 
                    been participating in therapy with the TheraSuit®. 
                    They found abnormal EEG signals at the start of the therapy 
                    and actually found normalizing EEG signals as the therapy 
                    progressed. The research had also made claims that this normalizing 
                    can help to normalize muscle tone.  
                   
                    IV. The Benefits of TheraSuit®: 
                     
                     
                  
                    -  
                      
Provide 
                        the dynamic tactile and proprioceptive inputs to influence 
                        the vestibular system and normalize the muscle tone. 
                     
                    -  
                      
Improve 
                        the body awareness and spatial orientation. 
                     
                    -  
                      
Reduce 
                        the abnormal pathological reflexes and stereotyped movement 
                        pattern. 
                     
                    -  
                      
Provide 
                        the dynamic correction of body alignment to as close to 
                        normal as possible in static posture and dynamic transitions. 
                     
                    -  
                      
Provide 
                        the external support/stabilization to the weak muscles 
                        or muscle groups. 
                     
                    -  
                      
Reduce 
                        the compensatory movement pattern to lower the energy 
                        consumption during transitions and locomotion. 
                     
                    -  
                      
Re-train 
                        the central nervous system. 
                     
                    -  
                      
Improve 
                        the graded balance and coordination control. 
                     
                    -  
                      
Speed 
                        up the new movement patterns and functional skills learning 
                        and development. 
                     
                    -  
                      
Decrease 
                        involuntary and uncontrolled movements in Ataxia and Athetosis. 
                     
                    -  
                      
Improve 
                        the fluency of airway and speech production. 
                         
                     
                   
                   
                   
                    V. The Indications of TheraSuit®: 
                  
                    -  
                      
 
                        Cerebral Palsy 
                     
                    -  
                      
Neuro-muscular 
                        Disorders (Spasticity/ Hypotonia) 
                     
                    -  
                      
 
                        Muscular-skeletal Disorders 
                     
                    -  
                      
Post 
                        Stroke (CVA) Patient 
                     
                    -  
                      
Spinal 
                        Cord Injuries and Spina Bifida 
                     
                    -  
                      
Traumatic 
                        Brain Injury 
                     
                    -  
                      
 
                        Ataxia 
                     
                    -  
                      
Athetosis 
                         
                     
                   
                   
                    VI. The Contraindications of TheraSuit®: 
                    
                  
                   
                    VII. The Precautions of TheraSuit®: 
                    
                  
                    
                   
                    The TheraSuit® 
                    meets all requirements 
                    of FDA regulations and is FDA listed and registered. There 
                    is no age limit to use TheraSuit® 
                    (please review 
                    the contraindications and precautions of the TheraSuit®). 
                    Although the clinical concepts of TheraSuit® 
                    to be very simple, 
                    professional certified training is require to ensured the 
                    safety of the patient and quality of treatment.  
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