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使用仪器辅助矫正运动的躯干支撑对青少年特发性脊柱侧凸的脊柱畸形、肺功能、躯干肌肉耐力和生活质量的疗效:平行组临床研究方案

The Efficacy of Trunk Bracing With an Instrumented Corrective Exercise on Spinal Deformity, Pulmonary Function, Trunk Muscle Endurance, and Quality of Life in Adolescent Idiopathic Scoliosis: Protocol for a Parallel Groups Clinical Study.

作者信息

Rezaeian Zeinab, Andalib Ali, Bokaee Fateme, Poorpooneh Najafabadi Maryam, Yeowell Gillian, Sadeghi-Demneh Ebrahim

机构信息

Department of Orthotics and Prosthetics, Musculoskeletal Research Center, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

Department of Orthopaedic Surgery, Musculoskeletal Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

JMIR Res Protoc. 2023 Mar 29;12:e43265. doi: 10.2196/43265.

DOI:10.2196/43265
PMID:36989018
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10131677/
Abstract

BACKGROUND

Adolescent idiopathic scoliosis is a 3D spine distortion with an unidentified etiology. It results in noticeable trunk deformity, decreased muscle strength and endurance at the trunk, changes in chest volume, breathing issues, and ultimately a decline in the quality of life. Trunk bracing and corrective exercises make up most of the treatment of patients with scoliosis when their deformity is between 20° and 45°, and they have not yet attained skeletal maturity. Evidence suggests that spinal deformity in people with scoliosis may result from improper motor control. Automatic response training is an exercise therapy technique that can modify the pattern of trunk muscle control for supporting the spinal column in normal alignment. An apparatus called a cantilever device is required for this type of exercise, which facilitates training at home. In spite of research showing the benefit of braces and therapeutic exercise in adolescents with scoliosis, less emphasis has been given to the impact of home-based training, especially when this intervention is paired with braces.

OBJECTIVE

We aim to compare the efficacy of bracing and a conventional exercise program to a combination treatment that includes trunk bracing and exercises with a cantilever device performed at home on the degree of spine curvature, pulmonary function, trunk muscular endurance, and quality of life.

METHODS

This study was a 2-arms parallel-group clinical study. A total of 16 adolescents with idiopathic scoliosis and single lumbar and thoracolumbar curves of 20°-45° were recruited and randomly assigned into 2 groups. Group A received a combination of trunk bracing and exercise using an instrument known as a "cantilever." Group B (controls) received trunk bracing and a conventional exercise program (without a tool). The study outcomes were the Cobb angle of the scoliotic curve, pulmonary function, the endurance of the trunk muscles, and quality of life. The study outcomes were measured at 2 time points: before the intervention (T1) and 12 weeks following the start of the intervention (T2; at this time, the intervention period has been completed). Multivariate analysis of variance was used to test between- and within-group differences.

RESULTS

Recruitment for this study began in fall 2022 and is expected to be completed by the end of summer 2023.

CONCLUSIONS

We studied the efficacy of a combined trunk bracing program and postural response exercises using a cantilever device in treating adolescent idiopathic scoliosis and compared it with trunk bracing and conventional home exercises. Exercises performed at home using a cantilever device are anticipated to raise the endurance of trunk muscles, which will help reduce trunk deformity, enhance pulmonary function, and improve the quality of life of participants.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials IRCT20220330054371N1; https://www.irct.ir/trial/62811.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43265.

摘要

背景

青少年特发性脊柱侧凸是一种病因不明的三维脊柱畸形。它会导致明显的躯干畸形、躯干肌肉力量和耐力下降、胸腔容积改变、呼吸问题,最终导致生活质量下降。当脊柱侧凸患者的畸形角度在20°至45°之间且尚未达到骨骼成熟时,躯干支具和矫正运动构成了大多数治疗方法。有证据表明,脊柱侧凸患者的脊柱畸形可能是由于运动控制不当所致。自动反应训练是一种运动治疗技术,可以改变躯干肌肉控制模式,以支持脊柱保持正常排列。这种类型的运动需要一种称为悬臂装置的器械,这便于在家中进行训练。尽管有研究表明支具和治疗性运动对青少年脊柱侧凸有益,但对家庭训练的影响关注较少,尤其是当这种干预与支具配合使用时。

目的

我们旨在比较支具和传统运动方案与一种联合治疗方案的疗效。联合治疗方案包括躯干支具以及在家中使用悬臂装置进行的运动,比较它们对脊柱弯曲程度、肺功能、躯干肌肉耐力和生活质量的影响。

方法

本研究为双臂平行组临床研究。共招募了16名患有特发性脊柱侧凸且单腰段和胸腰段曲线为20° - 45°的青少年,并将他们随机分为两组。A组接受躯干支具和使用一种称为“悬臂”的器械进行运动的联合治疗。B组(对照组)接受躯干支具和传统运动方案(不使用工具)。研究结果包括脊柱侧凸曲线的Cobb角、肺功能、躯干肌肉耐力和生活质量。在两个时间点测量研究结果:干预前(T1)和干预开始后12周(T2;此时,干预期已完成)。采用多变量方差分析来检验组间和组内差异。

结果

本研究于2022年秋季开始招募,预计于2023年夏末完成。

结论

我们研究了联合躯干支具方案和使用悬臂装置进行姿势反应运动在治疗青少年特发性脊柱侧凸方面的疗效,并将其与躯干支具和传统家庭运动进行了比较。预计在家中使用悬臂装置进行的运动将提高躯干肌肉的耐力,这将有助于减少躯干畸形、增强肺功能并改善参与者的生活质量。

试验注册

伊朗临床试验注册中心IRCT20220330054371N1;https://www.irct.ir/trial/62811。

国际注册报告识别码(IRRID):PRR1 - 10.2196/43265。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cb1/10131677/88bc2f3e0e5b/resprot_v12i1e43265_fig7.jpg
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Nonoperative management of adolescent idiopathic scoliosis (AIS) using braces.青少年特发性脊柱侧凸(AIS)的支具非手术治疗。
Prosthet Orthot Int. 2022 Aug 1;46(4):383-391. doi: 10.1097/PXR.0000000000000117. Epub 2022 Mar 23.
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The Italian Spine Youth Quality of Life questionnaire: reliability and validity of the Persian version in adolescents with spinal deformities.意大利脊柱青年生活质量问卷:脊柱畸形青少年波斯文版本的信度和效度。
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Asymmetrical activation and asymmetrical weakness as two different mechanisms of adolescent idiopathic scoliosis.
不对称激活和不对称无力作为青少年特发性脊柱侧凸的两种不同机制。
Sci Rep. 2021 Sep 2;11(1):17582. doi: 10.1038/s41598-021-96882-8.
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Adolescent idiopathic scoliosis: indications for bracing and conservative treatments.青少年特发性脊柱侧凸:支具治疗及保守治疗的指征
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Establishing consensus on the best practice guidelines for the use of bracing in adolescent idiopathic scoliosis.就青少年特发性脊柱侧凸支具使用的最佳实践指南达成共识。
Spine Deform. 2020 Aug;8(4):597-604. doi: 10.1007/s43390-020-00060-1. Epub 2020 Feb 5.
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The Italian Spine Youth Quality of Life questionnaire measures health-related quality of life of adolescents with spinal deformities better than the reference standard, the Scoliosis Research Society 22 questionnaire.意大利脊柱青少年生活质量问卷比参考标准,即脊柱侧凸研究协会 22 问卷,更能衡量脊柱畸形青少年的健康相关生活质量。
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