中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600122089
最近更新日期： Date of Last Refreshed on：	2026-04-09 08:31:57
注册时间： Date of Registration：	2026-04-09 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	特定性矫正训练对青少年特发性脊柱侧弯的疗效及安全性研究
Public title：	A Study on the Efficacy and Safety of Specific Correction Training for Adolescent Idiopathic Scoliosis
注册题目简写：
English Acronym：
研究课题的正式科学名称：	特定性矫正训练对青少年特发性脊柱侧弯的疗效及安全性研究
Scientific title：	A Study on the Efficacy and Safety of Specific Correction Training for Adolescent Idiopathic Scoliosis
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	蒋阳	研究负责人：	宋艳萍
Applicant：	Yang Jiang	Study leader：	Yanping Song
申请注册联系人电话： Applicant telephone：	+86 134 0884 8701	研究负责人电话： Study leader's telephone：	+86 871 6380 4660
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	whiteday7799@163.com	研究负责人电子邮件： Study leader's E-mail：	419459774@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	云南省昆明市呈贡区聚贤街768号	研究负责人通讯地址：	云南省昆明市呈贡区祥云街2628号
Applicant address：	No. 768, Juyan Street, Chengguan District, Kunming City, Yunnan Province	Study leader's address：	No. 2628, Xiangyun Street, Chengguan District, Kunming City, Yunnan Province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	云南师范大学体育学院
Applicant's institution：	Yunnan Normal University
研究负责人所在单位：	昆明市中医医院
Affiliation of the Leader：	Kunming Hospital of Traditional Chinese Medicine

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	伦审(2025-011-01)号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	昆明市中医医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Kunming Hospital of Traditional Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-09 00:00:00
伦理委员会联系人：	张容秀
Contact Name of the ethic committee：	Rongxiu Zhang
伦理委员会联系地址：	云南省昆明市呈贡区祥云街2628号
Contact Address of the ethic committee：	No. 2628, Xiangyun Street, Chengguan District, Kunming City, Yunnan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 139 8766 7679	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

昆明市中医医院

Primary sponsor：

Kunming Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

云南省昆明市呈贡区祥云街2628号

Primary sponsor's address：

No. 2628, Xiangyun Street, Chengguan District, Kunming City, Yunnan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	云南	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	昆明市中医医院	具体地址：	云南省昆明市呈贡区祥云街2628号
Institution hospital：	Kunming Hospital of Traditional Chinese Medicine	Address：	No. 2628, Xiangyun Street, Chengguan District, Kunming City, Yunnan Province

经费或物资来源：

课题经费

Source(s) of funding：

Project funding

研究疾病：

青少年特发性脊柱侧弯

Target disease：

Adolescent idiopathic scoliosis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

借助脊柱光栅立体三维检测系统和足底压力检测仪，评估运动疗法对青少年特发性脊柱侧弯患者治疗前后脊柱曲度和足底压力的影响。

Objectives of Study：

By using the spinal grating stereoscopic three-dimensional detection system and the foot pressure detector, the effects of exercise therapy on the spinal curvature and foot pressure of adolescent idiopathic scoliosis patients before and after treatment were evaluated.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.既往有脊柱手术史； 2.近期接受过脊柱矫正治疗； 3.背部存在可能影响测量的大面积瘢痕或皮肤病变； 4.无法配合完成检查或数据采集不完整者。

Exclusion criteria：

1. Has a history of previous spinal surgery; 2. Recently received spinal correction treatment; 3. Has a large area of scar or skin lesion on the back that may affect measurement; 4. Unable to cooperate with the examination or incomplete data collection.

研究实施时间：

Study execute time：

从 From 2025-07-10 00:00:00至 To 2028-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-07-12 00:00:00 至 To 2028-06-30 00:00:00

干预措施：

Interventions：

组别：	核心稳定训练组	样本量：	15
Group：	Core stability training group	Sample size：	15
干预措施：	接受热身活动放松训练后接受核心稳定训练。核心稳定训练分两阶段，第一阶段激活核心肌群（尤其腹横肌），提升脊柱本体感觉与协调性。腹横肌激活后进入第二阶段，针对核心肌群（腹内斜肌、腹外斜肌、臀大肌、臀中肌）进行高强度训练，增强稳定性和耐力【36】。动作主要包括臀桥、平板支撑、鸟狗式、侧支撑、死虫，具体如下：①臀桥：仰卧，双腿屈曲，脚跟着地，抬臀至大腿与身体呈一条直线，抬臀呼气，下落吸气。②平板支撑：俯卧，双肘支撑，双脚掌 / 双膝着地，头、肩、骨盆、腿呈同一平面，腹肌收紧，目视地面，保持均匀呼吸。③鸟狗式：双膝、双手支撑跪位，核心收紧，一侧腿和对侧手臂同时伸展，双侧交替。④侧支撑：一侧前臂和脚撑地，腹部收紧，侧抬臀至头、脊柱、腿在一条线上。⑤死虫：仰卧，双上肢屈曲 90°，双下肢屈髋屈膝 90°，腹部收紧，一侧腿和对侧手臂同时下降，双侧交替。以上每次运动持续约45分钟，每节训练重复4-5组，每组重复6-10次。运动强度依据患者耐受确定，次日不感到疲劳为宜。	干预措施代码：
Intervention：	After undergoing the warm-up relaxation training, core stability training is carried out. The core stability training is divided into two stages. In the first stage, the core muscle groups (especially the transverse abdominis muscle) are activated to enhance the proprioception and coordination of the spine. After activating the transverse abdominis muscle, the second stage begins, where high-intensity training is conducted on the core muscle groups (internal and external oblique abdominis muscles, gluteus maximus, and gluteus medius) to enhance stability and endurance [36]. The movements mainly include hip bridge, plank, bird dog position, side support, and dead bug. Specifically: ① Hip bridge: Lie on your back, bend your legs, place your feet on the ground, lift your buttocks until your thighs are in a straight line with your body, exhale when lifting, inhale when lowering. ② Plank: Lie face down, support yourself with your elbows, feet flat on the ground, head, shoulders, pelvis, and legs in the same plane, tighten your abdominal muscles, look at the ground, maintain even breathing. ③ Bird dog position: Support yourself on your knees and hands in a kneeling position, tighten your core, simultaneously extend one leg and the opposite arm, alternate on both sides. ④ Side support: Place one forearm and one foot on the ground, tighten your abdomen, lift your buttocks to align your head, spine, and legs in a straight line. ⑤ Dead bug: Lie on your back, bend your upper arms at 90 degrees, lower your lower limbs with hip and knee flexion at 90 degrees, tighten your abdomen, simultaneously lower one leg and the opposite arm, alternate. Each movement lasts for about 45 minutes. Each training session repeats 4-5 sets, with each set repeated 6-10 times. The intensity of the exercise is determined based on the patient's tolerance, and there is no discomfort the next day.	Intervention code：

组别：	施罗斯训练组	样本量：	15
Group：	Schroth exercise group	Sample size：	15
干预措施：	将在接受热身活动后放松训练后接受施罗斯训练。施罗斯训练包括去旋转、脊柱伸长、去屈曲、强化和旋转呼吸拉伸运动，以保持脊椎的排列整齐。根据AIS患者的侧弯类型合理选取适合的动作训练：①对于胸椎侧凸患者：包括矫正胸部区域、悬挂、拉伸凹侧（弱侧）、加强后躯干肌肉和坐在瑞士球上。②对于腰椎侧凸患者：包括腰椎区域矫正、悬挂技术、侧桥（侧髋提升）、凹侧或弱侧拉伸和躯干后部肌肉的加强。③对于胸腰椎弯曲患者：包括胸腰椎区域的矫正、基本矫正坐姿、悬挂技术、镜子前的自我矫正、凹侧或弱侧的拉伸以及躯干后部肌肉的加强。以上各项治疗每次持续约45分钟，每次训练进行4-6组，每组重复6-10次。	干预措施代码：
Intervention：	After the warm-up and relaxation exercises, Schroth training will be conducted. Schroth training includes de-rotation, spinal elongation, de-flexion, strengthening and rotational breathing stretching exercises to maintain the alignment of the spine. According to the type of scoliosis in AIS patients, suitable movements are selected for training: ① For thoracic scoliosis patients: it includes correction of the chest area, hanging, stretching the concave side (weak side), strengthening the posterior trunk muscles and sitting on a Swiss ball. ② For lumbar scoliosis patients: it includes correction of the lumbar area, hanging technique, side bridge (side hip lift), stretching the concave or weak side and strengthening the posterior trunk muscles. ③ For thoracolumbar scoliosis patients: it includes correction of the thoracolumbar area, basic corrective sitting posture, hanging technique, self-correction in front of the mirror, stretching the concave or weak side and strengthening the posterior trunk muscles. Each treatment lasts about 45 minutes, with 4-6 sets of training each time, and each set is repeated 6-10 times.	Intervention code：

组别：	核心稳定训练+施罗斯	样本量：	15
Group：	Core stability training + Schlosser	Sample size：	15
干预措施：	将接受核心稳定训练+施罗斯的联合训练计划。同前两组一样，在完成热身活动后进入正式锻炼。在每次训练中，参与者首先会接受核心稳定训练再接受施罗斯训练。训练内容与核心稳定训练组和施罗斯训练组相同，但为了控制时间变量的影响，针对核心稳定训练和施罗斯训练的训练时长都将减半，保持每次持续约45分钟。	干预措施代码：
Intervention：	They will undergo the combined training program of core stability training and Schloss's training. Just like the previous two groups, after completing the warm-up activities, they will enter the formal exercise. In each training session, participants will first receive core stability training and then Schloss training. The training content is the same as that of the core stability training group and the Schloss training group. However, to control the influence of the time variable, the training duration for both core stability training and Schloss training will be halved, maintaining approximately 45 minutes each time.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	云南	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	昆明市中医医院	单位级别：	三甲
Institution hospital：	Kunming Hospital of Traditional Chinese Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	脊柱三维形态	指标类型：	主要指标
Outcome：	Three-dimensional shape of the spine	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	足底压力	指标类型：	主要指标
Outcome：	Foot sole pressure	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者的体态检查	指标类型：	次要指标
Outcome：	The physical examination of the patient	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	10	岁 years
最大 Max age	20	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由不参与试验的人员使用Microsoft Excel 2021生成随机数用于参与者编码。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random numbers were generated using Microsoft Excel 2021 by personnel who were not involved in the experiment for the purpose of participant coding.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	对评估者和统计学家设盲
Blinding：	Blinding the evaluators and statisticians
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	研究结束后半年内，通过ResMan(www.medresman.org.cn)方式共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within six months after the completion of the research, the results will be shared via ResMan (www.medresman.org.cn)
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-04-09 08:31:51