The Intelligent Automated Pressure-Adjustable Orthosis for Patients With Adolescent Idiopathic Scoliosis

Abstract

Study Design. Randomized controlled trial. Objective. To compare the effectiveness of the automated pressure-adjustable orthosis (PO) and conventional orthosis (CO) for treatment of adolescent idiopathic scoliosis (AIS). Summary of Background Data. Orthosis wearing quality may influence its effectiveness for AIS. An automated PO aimed to provide a more optimized and consistent biomechanical environment. Clinical evaluation was conducted to study the effectiveness of this innovative orthosis. Methods. Patients with AIS who met the criteria (Age 10–14, Cobb 20°–40°, and Risser sign 0–2) were recruited from two clinics and randomly assigned to the PO and CO groups. Compliance sensors were embedded in both groups, while the PO group was set to adjust the interfacial pressure as prescribed automatically. Clinical assessments (radiology and quality of life, QoL) were conducted at the baseline, immediate after orthosis fitting and 1-year follow-up. Orthosis wearing compliance was tracked using thermo and pressure sensors. Results. Twenty-four patients were enrolled with one drop-out (PO, n = 11; CO, n = 12). Significant immediate in-orthosis correction was observed in the PO (11.0° ± 6.5°, 42.0%, P < 0.001) and CO (10.3° ± 5.3°, 37.6%, P < 0.001) groups. After 1 year, no patient with PO progressed while two with CO had progression more than 5°. The mean daily wearing duration was 1.1 hours longer in the PO group as compared with the CO group (15.4 ± 4.5 vs. 14.3 ± 3.8 h). Moreover, the wearing quality within the targeted pressure was 33.9% higher in the PO group (56.5 ± 16.5% vs. 23.1 ± 12.1%, P < 0.001). No significant difference in the QoL results was observed between two groups nor within both groups during the study period. Conclusion. This study showed that the automated PO could enhance wearing quality when compared with the CO, thus offering a better biomechanical corrective effect in the study period without adverse effect on the patients’ wearing quantity and QoL. Level of Evidence: 1

The Effectiveness of Different Concepts of Bracing in Adolescent Idiopathic Scoliosis (AIS): A Systematic Review and Meta-Analysis

“…Pressure-adjustable orthosis was developed by Yangmin Lin et al in 2020 ( n = 24). The reported treatment success was 100% after 1 year of treatment [ 33 ].…”

Which interventions may improve bracing compliance in adolescent idiopathic scoliosis? A systematic review and meta-analysis

“…The six included studies were published between 2012 and 2020. They consisted of three RCTs [ 35 , 36 , 40 ], one non-randomized controlled trial [ 37 ], one retrospective cohort study [ 39 ], and one retrospective case-control study [ 38 ] ( Table 1 ). The median sample size was 31 participants (range: 21–246 participants).…”

“…The median sample size was 31 participants (range: 21–246 participants). Two studies were conducted in the USA [ 35 , 36 ], two in Italy [ 38 , 39 ], one in Denmark [ 37 ], and one in Hong Kong [ 40 ]. The mean age of participants across 6 studies ranged from 11.9 to 15.8 years and the proportion of girls in each study ranged from 68.4% to 100%.…”

“…The mean age of participants across 6 studies ranged from 11.9 to 15.8 years and the proportion of girls in each study ranged from 68.4% to 100%. Bracing compliance was assessed through self-reporting [ 37 , 38 ] and sensor monitoring [ 35 , 36 , 39 , 40 ].…”

“…One RCT [ 40 ] was found to investigate the effectiveness of a newly developed automated pressure-adjustable orthosis, which could maintain a more consistent interfacial corrective effect at the prescribed level by inflation and deflation of the air bladder. Compliance monitoring sensors of similar size compared to the smart device for the intervention group were installed in the same area in the conventional rigid braces for the control group.…”