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.
