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针对特发性脊柱侧凸青少年的反馈式平衡训练

2026年10月4日 更新者:Seyma Alkan、Ankara Etlik City Hospital

在青少年特发性脊柱侧凸患者中,基于反馈的平衡训练结合个体化保守性脊柱侧凸运动与单纯个体化保守性脊柱侧凸运动对平衡能力的影响比较:一项前瞻性随机对照试验

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis occurring during the growth period and is associated with significant alterations in postural balance compared with healthy peers. Prior research has shown that adding sensorimotor or balance-focused training to scoliosis-specific exercises may produce greater improvements in postural control and overall balance function than scoliosis-specific exercises alone. However, no study has previously investigated the effects of feedback-based balance training using a multi-axial platform with real-time biofeedback (the HUBER® 360 Evolution system) in this population.

The aim of this study is to evaluate the effect of adding HUBER® 360-based feedback balance training to individualized conservative scoliosis exercises on postural balance, postural symmetry, and health-related quality of life in adolescents with AIS.

The intervention protocol consists of 12 sessions delivered over 4 weeks, three sessions per week. Each session comprises 40 minutes of individualized conservative scoliosis exercises (identical between arms) followed by 30 minutes of balance training that differs between arms: HUBER® 360-based feedback balance training delivered in the clinic in the intervention arm, and a structured home-based balance exercise program performed independently after physiotherapist instruction in the active comparator arm.

Outcomes are assessed at three time points: T0 (baseline, week 0), T1 (immediately post-intervention, week 4), and T2 (12-week follow-up, week 16 from baseline). The primary outcome is the Stability Index measured by the TecnoBody ProKin stabilometric platform. Pre-specified key secondary outcomes include mediolateral standard deviation of the center of pressure, Romberg area ratio, Limits of Stability, the Scoliosis Research Society-22 Patient Questionnaire (SRS-22) total score, and single-leg stance time. Additional exploratory outcomes include further static, dynamic, and proprioceptive balance parameters from the TecnoBody ProKin platform; postural asymmetry parameters from the DIERS Formetric 4D rasterstereography system; and SRS-22 subdomain scores.

研究概览

详细说明

Background

Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal deformity, with a global prevalence of approximately 1-3% in adolescents aged 10-18 years. AIS is associated with paraspinal proprioceptive impairment, altered sensory reweighting, and biomechanical asymmetry of the trunk, all of which can disturb static and dynamic postural control. Conservative scoliosis-specific exercises are recommended by the 2016 SOSORT (International Society on Scoliosis Orthopaedic and Rehabilitation Treatment) guidelines as the first-line conservative treatment for mild-to-moderate AIS curves.

Recent randomized trials have suggested that adding sensorimotor or balance-focused training to scoliosis-specific exercises produces greater improvements in postural control and trunk symmetry than scoliosis-specific exercises alone. However, conventional balance training relies on therapist-mediated external feedback and does not provide quantitative real-time information on postural sway or weight distribution. Motor learning research indicates that augmented (device-based) visual feedback accelerates motor control acquisition, particularly when intrinsic proprioceptive feedback is impaired. The HUBER® 360 Evolution (LPG Systems, Valence, France) is a multi-axial neuromuscular training platform with force sensors in its handles and an integrated screen that delivers real-time visual biofeedback on applied force and weight distribution. Although its clinical efficacy has been demonstrated in chronic non-specific low back pain and other musculoskeletal populations, its effect in AIS has not previously been investigated in a controlled study.

Study Design

This is a prospective, two-arm, parallel-group, randomized controlled trial conducted at a single tertiary rehabilitation center.The a priori sample size required to detect a Group × Time interaction in the primary outcome at α = 0.05 and 80% power was calculated using G*Power as 50 participants (25 per arm); 72 participants are enrolled to allow for attrition during follow-up.

Interventions

The intervention protocol consists of 12 clinic-based sessions delivered over 4 weeks, three sessions per week. Each session comprises 40 minutes of individualized conservative scoliosis exercises (identical between arms) followed by a 30-minute balance training component that differs between arms.

The individualized conservative scoliosis exercise program is informed by the general principles outlined in the 2016 SOSORT guidelines (three-dimensional auto-correction, adaptation to activities of daily living, stabilization of the corrected posture, and patient education) and is tailored to each patient based on curve pattern, apex location, and clinical examination findings. The program is delivered by physiotherapists experienced in scoliosis rehabilitation but who are not formally certified in any specific Physiotherapeutic Scoliosis-Specific Exercise (PSSE) school.

Intervention arm: 40 minutes of individualized conservative scoliosis exercises followed by 30 minutes of HUBER® 360-based feedback balance training, both delivered under physiotherapist supervision in the clinic.

Active comparator arm: 40 minutes of individualized conservative scoliosis exercises delivered in the clinic under physiotherapist supervision, plus a 30-minute structured home-based balance exercise program performed by the participant independently after detailed instruction by a physiotherapist. The home-based balance program is performed three times per week for 4 weeks (matching the frequency and total exposure of the intervention arm) and includes bilateral and unilateral stance exercises, balance tasks with eyes open and closed, exercises on different surfaces, and controlled weight-shifting tasks, organized according to a progressive difficulty principle. No device-based or real-time biofeedback is used.

Outcome Assessment

Outcomes are assessed at three pre-specified time points: T0 (baseline, week 0), T1 (immediately after the 4-week intervention, week 4), and T2 (12-week follow-up, week 16 from baseline). All assessments use validated, device-based, automated measurement systems where applicable, minimizing observer bias.

The primary outcome is the change in the Stability Index, a measure of overall postural control performance during a multi-axial dynamic balance task on the TecnoBody ProKin PK252 stabilometric platform (TecnoBody S.r.l., Dalmine, Italy), where lower values indicate better postural stability. This parameter is conceptually comparable to the Overall Stability Index (OSI) reported by the Biodex Balance System, which was used as the reference source for the a priori sample size calculation.

Pre-specified key secondary outcomes are: change in mediolateral standard deviation of the center of pressure; change in Romberg area ratio (eyes-closed to eyes-open sway area); change in Limits of Stability (LOS); change in the Scoliosis Research Society-22 Patient Questionnaire (SRS-22) total score; and change in single-leg stance time.

Pre-specified exploratory outcomes include the remaining TecnoBody ProKin static, dynamic, and proprioceptive parameters; postural and spinal alignment parameters measured by the DIERS Formetric 4D rasterstereographic surface topography system (DIERS International GmbH, Wiesbaden, Germany); and SRS-22 subdomain scores (function/activity, pain, self-image, mental health).

研究类型

介入性

注册 (实际的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Yenimahalle
      • Ankara、Yenimahalle、土耳其(türkiye)、06170
        • Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age between 10 and 17 years
  • Diagnosis of adolescent idiopathic scoliosis confirmed by a specialist physiatrist
  • No history of brace treatment
  • Radiological evaluation showing a Cobb angle between 10° and 25°

Exclusion Criteria:

  • Congenital scoliosis
  • Neuromuscular scoliosis
  • History of spinal surgery (including procedures involving paravertebral muscles or other spinal operations)
  • Presence of metabolic bone disease affecting skeletal structure
  • Severe autoimmune or endocrinological disease
  • Connective tissue disorder or skeletal dysplasia
  • Mental retardation preventing comprehension of simple instructions
  • Advanced peripheral joint disease
  • Coexisting polyneuropathy
  • Coexisting myopathy
  • Central nervous system disease that may affect balance
  • History of abdominal surgery or abdominal trauma
  • Presence of additional chronic comorbidities
  • Lack of parental consent for participation in the study
  • Functional scoliosis
  • Current or prior brace use

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Individualized Conservative Scoliosis Exercises + HUBER® 360 Feedback Balance Training

Participants in this arm receive 40 minutes of clinic-based, physiotherapist-supervised individualized conservative scoliosis exercises followed by 30 minutes of HUBER® 360-based feedback balance training in the clinic. Sessions are delivered three times per week for 4 weeks (12 sessions in total) by a physiotherapist on a one-to-one basis.

Participants complete 30-minute balance training sessions on the HUBER® 360 Evolution multi-axial neuromuscular training platform (LPG Systems, Valence, France). The platform delivers real-time visual biofeedback on weight distribution and applied force through force sensors in the handles and an integrated screen. The protocol focuses on stretching the posterior chain, opening and increasing the concavity, and reinforcing the convexity. Sessions are supervised by a physiotherapist on a one-to-one basis.

Participants perform 40-minute supervised exercise sessions tailored to each patient's curve pattern, apex location, and clinical findings. The program includes posture exercises, pelvic tilt, symmetric extension, scapular adduction with pectoral stretching, asymmetric lateral stretching, Cotrel exercise, flexibility and strengthening exercises, and active three-dimensional postural correction. All sessions are delivered one-to-one by a physiotherapist experienced in scoliosis rehabilitation.

有源比较器:Individualized Conservative Scoliosis Exercises + Home-Based Balance Exercise Program

Participants in this arm receive 40 minutes of clinic-based, physiotherapist-supervised individualized conservative scoliosis exercises three times per week for 4 weeks (12 clinic sessions in total). In addition, participants perform a 30-minute structured home-based balance exercise program three times per week for the same 4-week period. The home-based balance program is taught in detail by a physiotherapist prior to the intervention period and performed independently by the participant at home.

Participants perform 40-minute supervised exercise sessions tailored to each patient's curve pattern, apex location, and clinical findings. The program includes posture exercises, pelvic tilt, symmetric extension, scapular adduction with pectoral stretching, asymmetric lateral stretching, Cotrel exercise, flexibility and strengthening exercises, and active three-dimensional postural correction. All sessions are delivered one-to-one by a physiotherapist experienced in scoliosis rehabilitation.

Participants complete a 30-minute structured home-based balance exercise program three times per week for 4 weeks. The program is taught in detail by a physiotherapist prior to the intervention period and performed independently by the participant at home. It includes bilateral and unilateral stance exercises, balance tasks with eyes open and closed, exercises on different surfaces, and controlled weight-shifting tasks, organized according to a progressive difficulty principle. No device-based or real-time biofeedback is used.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Stability Index measured by the TecnoBody balance system
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

The primary outcome is the change in the Stability Index measured by the TecnoBody ProKin PK252 stabilometric platform (TecnoBody S.r.l., Dalmine, Italy). The Stability Index reflects overall postural control during a multi-axial dynamic balance task on the TecnoBody platform, where lower values indicate better postural stability. This parameter is conceptually comparable to the Overall Stability Index (OSI) reported by the Biodex Balance System, which was used as the reference source for the a priori sample size calculation.

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

次要结果测量

结果测量
措施说明
大体时间
Change in Mediolateral Standard Deviation of the Center of Pressure (CoP)
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Mediolateral postural sway variability is assessed during quiet standing on the TecnoBody ProKin PK252 stabilometric platform. The standard deviation of the medio-lateral component of the CoP trajectory is computed in millimeters, with lower values indicating reduced lateral postural sway.

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
Change in Romberg Area Ratio
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Visual contribution to postural balance is quantified using the Romberg area ratio, calculated as the ratio of the eyes-closed CoP sway area to the eyes-open CoP sway area, both measured by the TecnoBody ProKin PK252 stabilometric platform. Higher ratios indicate greater visual dependence for postural control.

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
Change in Limits of Stability (LOS)
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Functional dynamic balance is assessed using the Limits of Stability (LOS) test on the TecnoBody ProKin PK252 stabilometric platform. Participants perform controlled weight shifts toward eight directional targets, and the test result is expressed as the percentage of successfully reached targets within a fixed time. Higher LOS values indicate greater dynamic balance capacity.

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
Change in Postural Asymmetry Measured by the DIERS Formetric 4D Rasterstereographic Surface Topography System
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Postural asymmetry and three-dimensional spinal alignment are assessed using the DIERS Formetric 4D system (DIERS International GmbH, Wiesbaden, Germany), a validated, radiation-free rasterstereographic surface topography method that reconstructs the three-dimensional shape of the back from projected light patterns. Pre-specified parameters include scoliosis angle, coronal and sagittal trunk imbalance, pelvic obliquity, pelvic torsion, kyphotic and lordotic angles, vertebral surface rotation, and lateral deviation. For all parameters, values closer to zero indicate greater postural symmetry

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
Change in Unipodal Balance Test Performance
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Static balance will be assessed using the Unipodal Balance Test. The duration (in seconds) that the participant is able to maintain balance on the right and left leg separately will be recorded.

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
Change in Health-Related Quality of Life Measured by the Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
大体时间:Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

Health-related quality of life is assessed using the Scoliosis Research Society-22 Patient Questionnaire (SRS-22), a validated patient-reported outcome measure for adolescent idiopathic scoliosis. Four domains (function/activity, pain, self-image/appearance, mental health) and a total score derived from these four domains are analyzed. The original instrument's fifth domain (satisfaction with management) is excluded because it cannot be administered at baseline. Each item is rated on a 5-point Likert scale, and a mean score is calculated for each domain and as a total. Possible scores range from a minimum of 1 to a maximum of 5, with higher scores indicating better health-related quality of life.

Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)

其他结果措施

结果测量
措施说明
大体时间
Demographic Characteristics of Participants
大体时间:Baseline

Demographic data including age, sex, height, weight, and body mass index (BMI) will be collected to describe the study population and to explore potential correlations with balance outcomes.

Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Ece Ünlü Akyüz, MD, Professor、Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
  • 研究主任:Damla Cankurtaran, MD, Associate Professor、Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年4月4日

初级完成 (实际的)

2026年9月2日

研究完成 (实际的)

2026年9月2日

研究注册日期

首次提交

2026年2月18日

首先提交符合 QC 标准的

2026年2月18日

首次发布 (实际的)

2026年2月24日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月4日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared because this is a single-center, thesis-based clinical trial with a limited sample size and no external data repository plan.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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