No Clinical Advantage with Pressure-Adjusted Orthosis but Better Wearing Quality in AIS Patients .
The Intelligent Automated Pressure-Adjustable Orthosis for Patients With Adolescent Idiopathic Scoliosis: A Bi-Center Randomized Controlled Trial.
Spine (Phila Pa 1976). 2020 Oct 15;45(20):1395-1402Twenty-four females with adolescent idiopathic scoliosis (AIS) were randomized to receive an automated pressure-adjustable orthosis (n=12) or a conventional orthosis adjusted by the patient (n=12). Outcomes of interest included Cobb angle, time spent wearing orthosis, time spent wearing orthosis in the prescribed pressure range, wearing quality (time spent in pressure range / time spent wearing orthosis), Scoliosis Research Society 22r (SRS-22r) score and associated sub-scores, Brace Questionnaire (BrQ) score and associated sub-scores, and the number of patients with a >35% in-orthosis correction. Outcomes were assessed at 1 year post-treatment. Study findings demonstrated no statistically significant differences in Cobb angle between the two groups, both in-orthosis and at 1 year post-treatment. While no statistically significant difference in time spent wearing orthosis was observed between the two groups (p=0.55), patients in the automatic orthosis group reported longer time in the prescribed pressure range (p=0.001) and greater wearing quality (p=0.001) compared to the conventional group. No statistically significant differences in SRS-22r total score and sub-scores, and BrQ total score and sub-scores, were observed between the two groups at 1 year post-treatment (p>0.05 for all). The number of patients who reported a 35% in-orthosis correction was 72.7% in the automated orthosis group compared to 66.7% in the conventional group.
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