针对特发性脊柱侧凸青少年的反馈式平衡训练
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
研究概览
地位
条件
详细说明
青少年特发性脊柱侧凸(AIS)是生长期间最常见的脊柱侧凸类型。先前将AIS患者与健康对照组进行比较的研究显示,其平衡模式存在显著改变,多项研究已通过姿势描记法评估了基于运动干预的平衡参数。
例如,Osama等人(2021年)报告称,与仅进行Schroth锻炼相比,马术疗法与Schroth锻炼相结合能更大程度地改善姿势不对称和平衡。类似地,Shen等人(2023年)证明,在特发性脊柱侧凸青少年中,将平衡训练与Schroth疗法结合,可显著改善躯干旋转角度、Cobb角、生活质量和整体平衡功能。
然而,迄今为止,尚无研究探讨使用HUBER® 360系统进行平衡训练对该人群平衡结果的影响。因此,本研究旨在评估在脊柱侧凸特异性锻炼基础上,增加使用HUBER® 360系统进行平衡训练对特发性脊柱侧凸青少年平衡能力的影响。
干预方案包括在4周内进行12次训练,每周锻炼三次。参与者将被随机分配到两组。对照组将接受45分钟的个体化脊柱侧凸锻炼,随后进行30分钟的家庭平衡锻炼。干预组将接受45分钟的个体化脊柱侧凸锻炼,随后进行30分钟基于HUBER系统的平衡训练。
结果评估将在基线、4周干预后立即以及3个月随访时进行。主要结果将是使用Technobody平衡系统测量的平衡参数变化(静态和动态平衡、摆动面积、摆动速度和稳定性指数)。次要结果将包括生活质量(SRS-22问卷)、姿势不对称(DIERS 4D Formetric)、使用Fukuda踏步测试评估的动态平衡,以及静态平衡表现(分别针对右腿和左腿的单腿平衡测试)。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Yenimahalle
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Ankara、Yenimahalle、土耳其(türkiye)、06170
- Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
纳入标准:
- 年龄在10至17岁之间
- 经专科康复医师确诊为青少年特发性脊柱侧弯
- 无支具治疗史
- 影像学评估显示Cobb角在10°至25°之间
排除标准:
- 先天性脊柱侧弯
- 神经肌肉性脊柱侧弯
- 脊柱手术史(包括涉及椎旁肌的手术或其他脊柱手术)
- 存在影响骨骼结构的代谢性骨病
- 严重的自身免疫性疾病或内分泌疾病
- 结缔组织病或骨骼发育不良
- 智力障碍导致无法理解简单指令
- 晚期外周关节疾病
- 并存的多发性神经病
- 并存的肌病
- 可能影响平衡的中枢神经系统疾病
- 腹部手术史或腹部创伤史
- 存在其他慢性合并症
- 缺乏父母同意参与研究
- 功能性脊柱侧弯
- 当前或既往使用过支具
学习计划
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 |
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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.
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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.
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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.
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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.
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.
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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 |
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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)
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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.
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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)
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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.
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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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)
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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.
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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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)
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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.
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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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)
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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
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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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)
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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.
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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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)
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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.
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Baseline (T0), immediately post-intervention (T1, week 4), and at 12-week follow-up (T2, week 16)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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参与者的人口统计学特征
大体时间:基线
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将收集包括年龄、性别、身高、体重和身体质量指数(BMI)在内的人口统计学数据,以描述研究人群并探索与平衡结果之间的潜在相关性。
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基线
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合作者和调查者
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
一般刊物
- Le Berre M, Guyot MA, Agnani O, Bourdeauducq I, Versyp MC, Donze C, Thevenon A, Catanzariti JF. Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis. Eur Spine J. 2017 Jun;26(6):1638-1644. doi: 10.1007/s00586-016-4802-z. Epub 2016 Nov 14.
- Shen X, Yang Z, Zhang P, Xu Y, Wang J. Effects of balance training combined with Schroth therapy on adolescents with mild idiopathic scoliosis: A six-week randomized controlled trial. J Back Musculoskelet Rehabil. 2023;36(6):1365-1373. doi: 10.3233/BMR-220383.
- Abdel-Aziem AA, Abdelraouf OR, Ghally SA, Dahlawi HA, Radwan RE. A 10-Week Program of Combined Hippotherapy and Scroth's Exercises Improves Balance and Postural Asymmetries in Adolescence Idiopathic Scoliosis: A Randomized Controlled Study. Children (Basel). 2021 Dec 30;9(1):23. doi: 10.3390/children9010023.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- AEŞH-EK-2025-0136
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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