A feasibility study of application of purpose-design frame and 3-D clinical ultrasound in assessment and design of spinal orthoses for adolescent idiopathic scoliosis.

BACKGROUND: The immediate in-orthosis correction of adolescent idiopathic scoliosis (AIS) is a useful prognostic parameter for the long-term orthotic treatment outcome. The 3-D clinical ultrasound technique is considered a noninvasive alternative to assess scoliotic deformities that could be applied in the orthotic treatment of AIS. OBJECTIVE: This study aimed to investigate the feasibility of a purpose-design assessment frame in estimating biomechanical effects of the controlling pads of a spinal orthosis under the guidance of the ultrasound system. METHODS: Twenty-six subjects with AIS were recruited and arranged to position inside the assessment frame, and controlling pads were applied strategically while the scoliotic deformities were assessed by clinical ultrasound to obtain at least 30% curvature correction, and the body shape was then captured using a computer-aided design and computer-aided manufacture system, and spinal orthoses were subsequently fabricated. The preorthosis and immediate in-orthosis coronal and sagittal X-rays were used for comparison. RESULTS: X-ray assessments showed that the mean coronal Cobb angle and lumbar lordosis of the subjects from the preorthosis to immediate in-orthosis visits decreased significantly ( p < 0.05) from 29.6° to 16.6°, and from 47.2° to 35.3°, respectively. CONCLUSIONS: This feasibility study showed that the proposed method would have a good potential to improve orthotic treatment outcome in a documented approach that should be considered for implementation into routine clinical practice aiming to reduce the chance of deformity deterioration leading to surgical intervention. However, a controlled group study is required to compare the results.

Effect of different undergarment designs on the compliance and acceptance of the patients with adolescent idiopathic scoliosis under orthotic treatment.

BACKGROUND: Patient's acceptance and compliance to spinal orthosis could influence the outcome of orthotic treatment in adolescent idiopathic scoliosis. Two innovative undergarments (thin and thick designs) were designed to improve the patient's orthosis wearing experience and acceptance. OBJECTIVE: This study aimed to evaluate the effects of patients' self-provided undergarment and 2 newly designed undergarments with respect to the orthosis wearing compliance and quality of life (QoL) measures. METHODS: A prospective randomized-controlled study was conducted to compare the effect of three types of undergarments. Thirty-eight subjects with adolescent idiopathic scoliosis were randomly assigned to one of the three groups: self-provided, thin-design, or thick-design undergarment. Wearing compliance logbook, Scoliosis Research Society questionnaire, and Brace Questionnaire were used to document the orthosis wearing period and quantify the health-related and orthosis-related QoL measures. Kruskal-Wallis one-way analysis of variance (ANOVA) and Friedman two-way ANOVA by ranks tests were conducted for intergroup and intragroup comparisons, respectively. RESULTS: The compliance and QoL domains of the subjects in the thin-design undergarment group were significantly higher than those of the other two undergarment groups (P < .05). The intragroup compliance and QoL scores varied significantly in the 4 visits throughout the study period (P < .05). CONCLUSIONS: It was observed that an adaptation period toward the prescribed spinal orthosis is required to help patients gradually achieve a more stable acceptance. The thin-design undergarment was ranked higher than the other two tested undergarments in compliance and QoL measures.

The Intelligent Automated Pressure-Adjustable Orthosis for Patients With Adolescent Idiopathic Scoliosis: A Bi-Center Randomized Controlled Trial.

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°â€Š±â€Š6.5°, 42.0%, P < 0.001) and CO (10.3°â€Š±â€Š5.3°, 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 ±â€Š4.5 vs. 14.3 ±â€Š3.8 h). Moreover, the wearing quality within the targeted pressure was 33.9% higher in the PO group (56.5 ±â€Š16.5% vs. 23.1 ±â€Š12.1%, 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.

A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria.

PURPOSE: SpineCor is a relatively innovative brace for non-operative treatment of adolescent idiopathic scoliosis (AIS). However, the effectiveness of SpineCor still remains controversial. The objective of the current study was to compare the treatment outcomes of SpineCor brace with that of rigid brace following the standardized Scoliosis Research Society (SRS) criteria on AIS brace study. METHODS: Females subjects with AIS and aged 10-14 were randomly allocated into two groups undergoing treatment of SpineCor (S Group, n = 20) or rigid brace (R Group, n = 18). During SpineCor treatment, patients who had curve progression of >5° would be required to switch to rigid brace treatment. The effectiveness of the two brace treatments was assessed using the SRS standardized criteria. RESULTS: Before skeletal maturity, 7 (35.0%) patients in the S Group and 1 (5.6%) patient in the R Group had curve progression >5° (P = 0.026). At skeletal maturity, 5 of the 7 (71.4%) patients who failed with SpineCor bracing showed control from further progression by changing to rigid bracing. At the latest follow-up with a mean duration of 45.1 months after skeletally maturity, 29.4% of patients who were successfully treated by rigid brace showed further curve progression beyond skeletal maturity, versus 38.5% of patients in the SpineCor group (P > 0.05). For both groups, the primary curves were slightly improved at the time of brace weaning, but additionally increased at the latest follow-up, with a rate of 1.5° per year for post-maturity progression. CONCLUSIONS: Curve progression rate was found to be significantly higher in the SpineCor group when compared with the rigid brace group. Changing to rigid bracing could control further curve progression for majority of patients who previously failed with SpineCor bracing. For both SpineCor and rigid brace treatments, 30-40% of patients who were originally successfully treated by bracing would exhibit further curve progression beyond skeletal maturity. The post-maturity progression rate was found to be 1.5° per year in the current study, which was relatively greater than those reported before.

The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis.

STUDY DESIGN: A prospective study on the comparison of the clinical efficacy and patient's acceptance of the 2 orthotic management methods. OBJECTIVE: To compare the treatment effectiveness and patients' acceptance of the flexible spinal orthosis, SpineCor with that of the rigid spinal orthosis for the patients with moderate adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: The patients' acceptance to the rigid spinal orthoses is always a concern as it could greatly affect the clinical outcome. SpineCor is a relatively new design for tackling those inevitable drawbacks found in rigid orthosis. However, there was no study to compare this design with the conventional method regarding their treatment efficacy and the patient's acceptance. METHODS: Forty-three subjects with moderate adolescent idiopathic scoliosis were randomly assigned to the SpineCor group (S group, n = 22) and rigid orthosis group (R group, n = 21). Their survival rate in the first 45 months of intervention was studied. The subjects' acceptance to the orthoses was evaluated by a purpose-designed questionnaire, which was administered in the 3rd, 9th, and 18th months of intervention. RESULTS: In the study period, there were 68% of the subjects in the S group and 95% of the subjects in the R group did not show curve progression. Significant difference (P = 0.046, by Fisher exact test) in failure rate between the 2 subject groups was found although the 2 groups had similar responses to the questionnaire. CONCLUSION: The current study showed that the failure rate of the SpineCor was significantly higher than that of the rigid spinal orthosis, and the patients' acceptance to the SpineCor was comparable to the conventional rigid spinal orthosis.