The Development Of A Dynamic Adjustable Brace To Rescue Adolescent Scoliosis

Objective:Design and develop a new type of dynamic adjustable brace that meets the requirements of aesthetics,comfort,convenient adjustment of brace size and tension to accommodate the patient’s body type,for the treatment of Adolescent Idiopathic Scoliosis(AIS).This has clinical significance in improving the effectiveness of mild to moderate AIS treatment,reducing patient treatment costs,and lowering the surgical rate.Method:(1)Design Concept: Consider selecting a suitable material that is soft,stretch-resistant,elastic,and unlikely to cause skin allergies.The brace is composed of multiple interconnected parts.Instead of relying on the rigid corrective force of traditional braces,it utilizes a high-elasticity restraining system to provide a more flexible and adjustable pressure and rotational force.It generates a constant corrective force in the opposite direction of the convexity in the pressure zone to correct the imbalanced development of the paraspinal muscles caused by the asymmetry of the body during scoliosis.It can also improve excessive stretching of the muscles on the convex side and atrophy of the muscles on the concave side.It generates supporting forces on the opposite side of the deformity to counteract it,applying balanced pressure from the front,back,left,and right to prevent overcorrection of the spinal curvature,leading to compensatory deformities such as anterior or posterior protrusion.The brace also provides sufficient elasticity to support the spine,paraspinal muscles,and soft tissues.Through slight adjustments to the spine,it gradually restores the normal physiological curvature,maintaining spinal mobility and correcting three-dimensional deformities in various directions,thus providing better long-term treatment outcomes.(2)Sample Production: Based on the preliminary design concept of the adjustable dynamic brace treatment,a simple design drawing is created.An accurate design sketch is then produced by a patent company,and textile companies relevant to the sketch are identified for sample production.The textile companies are informed of the production concept,basic material requirements,dimensions,and structural characteristics.They manually produce the initial samples.(3)Initial Clinical Application: Firstly,the brace samples are submitted to relevant departments and hospitals for ethical approval,which is successfully obtained.Then,31 adolescents with mild to moderate idiopathic scoliosis who met the inclusion criteria from March 2021 to April 2022 in our hospital are enrolled.The brace samples from this study are used for follow-up treatment.Prior to treatment,patients and their families are informed of relevant precautions,such as the occurrence of complications and discomfort during treatment and their management,and they sign informed consent forms.Stand-up full-spine anteroposterior and lateral X-ray images are taken before treatment,at 6 months of treatment,and at 1 year of treatment,with Cobb angles measured and recorded.In addition,a simplified Chinese version of the SRS-22 patient questionnaire(refer to Appendix Figure 34)is distributed to all patients before treatment and at 1 year of treatment for evaluation.The clinical efficacy is assessed by comparing and analyzing the pre-and post-treatment conditions.The collected data are analyzed using SPSS 25.0 software.Results:(1)After detailed discussions between the authors and relevant companies regarding the research and development ideas,simple sketches,and design drawings,the following materials were selected for production: cowhide,PVC material,canvas material,carbon steel button device,plastic buckle device,elastic band,etc.These materials were assembled to create the initial samples.The follow-up period for the treatment group consisted of 1 year for all 31 patients.(2)Among the 27 patients,there was a decrease in the curvature of the scoliosis,indicating effective treatment.The pre-treatment Cobb angle was(26.9±3.37)°,and the Cobb angle at the 1-year follow-up was(20.3±5.76)°,with a correction rate of25.6%.The comparison of Cobb angles before and after treatment showed a statistically significant difference(t=7.045,P<0.01).Among these patients,4 cases showed a trend of worsening Cobb angle after treatment,suggesting treatment ineffectiveness.(3)SRS-22 Scale Scores: When comparing the scores of the 31 patients before and after treatment,there were statistically significant differences in functional activities(P<0.05),pain(P<0.05),self-image(P<0.05),and psychological health(P<0.05).Regarding the satisfaction rating of the treatment,84% of the patients expressed overall satisfaction,while 16% of the patients expressed relative dissatisfaction with the overall treatment.Conclusion:(1)The dynamic adjustable support sample for adolescent idiopathic scoliosis(AIS)in this study has a certain degree of efficacy in treating mild to moderate idiopathic scoliosis,which is clinically significant and a new AIS treatment method worthy of clinical promotion.(2)Further improvements can be made to expand the indications,such as developing and improving the sample to treat severe idiopathic scoliosis or other types of scoliosis,based on the author’s research ideas and feedback from trials,and iterating on multiple improvements in various aspects of the sample.