A New Spinal Orthosis for Adolescent Idiopathic Scoliosis
A New Spinal Orthosis for Adolescent Idiopathic Scoliosis
The new device with digital technology provides a new avenue to enable clinicians to
 communicate wirelessly with the imbedded core system such that they can adjust the electrical
 stimulation parameters and retrieve the temperature data for further compliance analysis. The
 smart phone and cloud technology can be effectively applied for both security and
 convenience. The electrical stimulation technology integrated with the total contact spinal
 orthosis combines the external correction forces on the spinal skeleton from the passive
 orthosis with the muscle forces at the lateral trunk from the stimulation process. The
 electrical stimulation is purposely to tone the muscle in order to replace the external
 mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may
 maintain the correction.
Spinal orthosis is an option to treat Adolescent Idiopathic Scoliosis (AIS) and is the most
 commonly used among conservative treatment. According to Scoliosis Research Society (SRS),
 orthotic treatment is indicated for AIS patients with curves greater than 25˚ but smaller
 than 45˚. However, the in-brace correction is hardly maintained and the effectiveness of
 orthotic treatment is limited, which has been an impetus to develop a more effective method
 for AIS patients to fulfill the unmet need. In order the orthosis is effective, biomechanical
 intervention and the patient compliance are two key factors. The purpose of this two-year
 project is to develop a new spinal orthosis in which an integrated system of electric surface
 stimulation and heat sensing is imbedded such that the AIS will be effectively treated with
 the mechanical orthosis plus a nocturnal use of electrical stimulation. In addition to the
 already stellar device, a totally new concept of spine erectability is proposed to provide
 evidence that can manifest the unique value of orthotic treatment as opposed to surgery. It
 is hypothesized that the new spinal orthosis would not only reduce the Cobb angle and apical
 rotation but also would strengthen the spine erectability in AIS patients. The new device
 with digital technology provides a new avenue to enable clinicians to communicate wirelessly
 with the imbedded core system such that they can adjust the electrical stimulation parameters
 and retrieve the temperature data for further compliance analysis. The smart phone and cloud
 technology can be effectively applied for both security and convenience. The electrical
 stimulation technology integrated with the total contact spinal orthosis combines the
 external correction forces on the spinal skeleton from the passive orthosis with the muscle
 forces at the lateral trunk from the stimulation process. The electrical stimulation is
 purposely to tone the muscle in order to replace the external mechanical forces gradually.
 Ultimately, when being weaned off the orthosis, patients may maintain the correction. With
 the spinal orthosis, the applied current in stimulation process would be reduced and the skin
 irritation would too. First year, there will be three tasks. An instrument will be developed
 for clinicians to assess the applicability of electrical surface stimulation to each AIS
 patient. System integration of the spinal orthosis with electrical surface stimulation and
 heat sensing will be accomplished. Clinical study of the effectiveness of passive spinal
 orthoses on 30 AIS subjects as a control group, where the Cobb angle, apical rotation and
 spine erectability will be measured before treatment and after. Second year, another 30 AIS
 patients will be recruited; the applicability of electrical surface stimulation will be
 assessed; and the new spinal orthosis will be applied to the experiment group. The Cobb
 angle, apical rotation and spine erectability will be measured before treatment and after for
 each subject. Independent t test will be carried out for the two groups to test the
 hypothesis.
Inclusion Criteria:

 -  (1) the range of age should be from ten years old to seventeen years old and (2) the
 Cobb angle should be from 20°to 45°.

 Exclusion Criteria:

 -  (1)not primary idiopathic scoliosis (2)Unable to wear the all-day brace