ChiCTR2300075910 版本V1.0 版本创建时间2023/09/19 15:42:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300075910 

最近更新日期：

Date of Last Refreshed on：

 2023-09-19 15:42:19 

注册时间：

Date of Registration：

 2023-09-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

神经调控联合肌电生物反馈技术治疗青少年特发性脊柱侧弯患者姿势控制障碍的应用机制研究

Public title：

Application mechanism of neuroregulation combined with myoelectric biofeedback in the treatment of postural control disorders in adolescent patients with idiopathic scoliosis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

神经调控联合肌电生物反馈技术治疗AIS患者姿势控制障碍的应用机制研究

Scientific title：

Application mechanism of neuroregulation combined with myoelectric biofeedback in the treatment of postural control disorders in adolescent patients with 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：

李柯蓉 

研究负责人：

孟繁媛 

Applicant：

Likerong 

Study leader：

Mengfanyuan 

申请注册联系人电话：

Applicant telephone：

 +86 184 6914 0795

研究负责人电话：

Study leader's
telephone：

+86 150 9663 4903

申请注册联系人传真 ：

Applicant Fax：

 659469 50

研究负责人传真：

Study leader's fax：

 659469 50

申请注册联系人电子邮件：

Applicant E-mail：

 1273153146@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 mengfanyuan@kmmu.edu.cn

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：

昆明市呈贡区雨花街道春融西路1168号

研究负责人通讯地址：

昆明市呈贡区雨花街道春融西路1168号

Applicant address：

No. 1168 Chunrong West Road, Yuhua Street, Chenggong District, Kunming

Study leader's address：

No. 1168 Chunrong West Road, Yuhua Street, Chenggong District, Kunming

申请注册联系人邮政编码：

Applicant postcode：

 650500

研究负责人邮政编码：

Study leader's postcode：

 650500

申请人所在单位：

昆明医科大学康复学院

Applicant's institution：

Kunming Medical University Rehabilitation School

研究负责人所在单位：

昆明医科大学康复学院

Affiliation of the Leader：

Kunming Medical University Rehabilitation School

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：

 KMMU2023MEC152

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：

昆明医科大学医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-07 00:00:00

伦理委员会联系人：

李利华

Contact Name of the ethic committee：

Li lihua

伦理委员会联系地址：

昆明市呈贡区雨花街道春融西路1168号

Contact Address of the ethic committee：

No. 1168 Chunrong West Road, Yuhua Street, Chenggong District, Kunming

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 184 6914 0795

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 1273153146@qq.com

研究实施负责（组长）单位：

昆明医科大学康复学院

Primary sponsor：

Kunming Medical University Rehabilitation School

研究实施负责（组长）单位地址：

昆明市呈贡区雨花街道春融西路1168号

Primary sponsor's address：

No. 1168 Chunrong West Road, Yuhua Street, Chenggong District, Kunming

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南省

市(区县)：

昆明市

Country：

China

Province：

Yunnan

City：

Kunming

单位(医院)：

昆明医科大学

具体地址：

昆明市呈贡区雨花街道春融西路1168号

Institution
hospital：

Kunming Medical University

Address：

No. 1168 Chunrong West Road, Yuhua Street, Chenggong District, Kunming

经费或物资来源：

云南省科技厅联合专项

Source(s) of funding：

Yunnan Province science and technology Department joint project

研究疾病：

脊柱侧弯  

Target disease：

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）本研究探索AIS患者和匹配的健康人中枢神经网络和双侧大脑半球皮层兴奋性的差异，以及脊柱椎旁肌表面肌电信号的不同。 （2）分析中枢神经环路和脊柱椎旁肌，对AIS患者姿势控制的影响。为临床制定AIS患者姿势控制障碍的康复训练提供循证依据。 （3）研究调控联合肌电生物反馈相比临床传统的保守治疗（支具，脊柱侧弯特殊物理治疗方法），对AIS患者患者的侧弯角度Cobb角，姿势控制，患者生活质量影响。  

Objectives of Study：

(1) This study explored the differences in central neural network and cortical excitability of bilateral cerebral hemispheres between AIS patients and matched healthy individuals, as well as the differences in surface EMG signals of spinal paravertebral muscles. (2) The effects of the central nervous circuit and spinal paravertebral muscles on posture control in AIS patients were analyzed. To provide an evidence-based basis for the rehabilitation training of AIS patients with postural control disorders. (3) Study the effects of regulation combined with myoelectric biofeedback on the lateral curvature Angle Cobb Angle, posture control and quality of life of patients with AIS, compared with traditional conservative clinical treatment (brace, special physical therapy for scoliosis).

药物成份或治疗方案详述：

干预方案：假肢矫形师评估和制作硬支具，并根据医嘱穿戴每日至少16-18小时，并进行记录。使用经颅磁刺激（TMS）进行中枢调控实现脑功能重塑。TMS是被证实的临床安全、有效、无创的中枢调控的仪器，已经广泛用于临床治疗神经疾病的患者。指导患者进行PSSE矫正训练。运动训练每周4-5次，每次训练时间30-40min,累计一周训练时间为4-5小时。 

Description for medicine or protocol of treatment in detail：

Intervention program: The prosthetist assesses and fabricates a hard brace, wears it for at least 16-18 hours per day as prescribed by the doctor, and records it. Using transcranial magnetic stimulation (TMS) for central regulation to achieve brain function remodeling. TMS is a clinically safe, effective and non-invasive instrument for central regulation and has been widely used in the clinical treatment of patients with neurological diseases. Instruct patients to perform PSSE correction training. Exercise training 4-5 times a week, each training time of 30-40min, the cumulative weekly training time of 4-5 hours.  

纳入标准：

1) 诊断为特发性脊柱侧弯的患者； 2) 年龄在10岁以上到18岁 （包括10岁）； 3) Risser征<3级以下） 4) Cobb角25-45°（主侧弯）； 5) 此前未接受过矫形器或手术治疗的患者； 6） 实验前签署知情同意书，告知患者在治疗过程中有任何不适，可以自愿选择退出研究。

Inclusion criteria

1) Patients diagnosed with idiopathic scoliosis; 2) Aged from 10 years to 18 years (including 10 years); 3) Risser sign < Level 3 and below) 4) Cobb Angle 25-45° (main side bend); 5) Patients who have not previously received orthotics or surgery; 6) Signed informed consent before the experiment, informing patients that they can voluntarily opt out of the study if they have any discomfort during the treatment.

排除标准：

1) 诊断为非特发性脊柱侧弯的患者（先天性脊柱侧弯、姿势性脊柱侧弯、神经肌肉型脊柱侧弯、代偿性脊柱侧弯等）； 2) 生长发育已经完全的患者（6个月内身高增加＜1cm的患者、Risser征≥4级的患者、距离月经初潮2年以上的女性患者）； 3) 患有无法进行运动训练疾病的患者； 4） 合并有其他心肺疾病或功能障碍的患者； 5) 显著认知缺陷无法完成SRS-22问卷和SF-36问卷的患者。

Exclusion criteria：

1) Patients diagnosed with non-idiopathic scoliosis (congenital scoliosis, postural scoliosis, neuromuscular scoliosis, compensatory scoliosis, etc.); 2) Patients with complete growth and development (patients with height increase < 1cm within 6 months, patients with Risser sign ≥4, female patients with more than 2 years from menarche); 3) Patients with diseases that prevent them from exercising; 4) Patients with other cardiopulmonary diseases or dysfunction; 5) Patients with significant cognitive deficits who were unable to complete the SRS-22 and SF-36 questionnaires.

研究实施时间：

Study execute time：

从 From 2023-09-01 00:00:00至 To 2025-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-01 00:00:00 至 To 2024-06-01 00:00:00

干预措施：

Interventions：

组别：

神经调控联合支具训练组

样本量：

 30

Group：

Neuroregulation joint brace training group

Sample size：

干预措施：

由假肢矫形师评估和制作硬支具，并根据医嘱穿戴每日至少16-18小时，并进行记录。在此基础上，一组进行中枢调控的训练。利用近红外fNIRS监测的同时，通过经颅磁刺激（TMS）进行中枢调控实现脑功能重塑。TMS是被证实的临床安全、有效、无创的中枢调控的仪器，已经广泛用于临床治疗神经疾病的患者。

干预措施代码：

Intervention：

A hard brace is assessed and made by a prosthetist and worn for at least 16-18 hours per day as directed by the doctor and recorded. On this basis, one group was trained in central regulation. In addition to near-infrared fNIRS monitoring, the brain function was remodeled by central regulation through transcranial magnetic stimulation (TMS). TMS is a clinically safe, effective and non-invasive instrument for central regulation and has been widely used in the clinical treatment of patients with neurological diseases.

Intervention code：

组别：

肌电生物反馈联合支具训练组

样本量：

 30

Group：

Electromyobiofeedback combined brace training group

Sample size：

干预措施：

在表面肌电的监测下观察患者运动时椎旁肌表面肌电信号，并同时指导患者在表面肌电的监测和反馈下进行PSSE矫正训练。运动训练每周4-5次，每次训练时间30-40min,累计一周训练时间为4-5小时。同时配合支具每日穿戴时间至少16-18小时。

干预措施代码：

Intervention：

The patients' paravertebral muscle surface electromyography was observed under the monitoring of surface electromyography, and the patients were guided to perform PSSE correction training under the monitoring and feedback of surface electromyography. Exercise training 4-5 times a week, each training time of 30-40min, the cumulative weekly training time of 4-5 hours. At the same time, wear the brace for at least 16-18 hours a day.

Intervention code：

组别：

PSEE训练联合支具训练组

样本量：

 30

Group：

PSEE Training Joint Brace Training Group

Sample size：

干预措施：

根据患者的侧弯类型，侧弯Cobb角度的大小进行PSSE训练的安排，训练内容包括：螺旋成角呼吸、三维平面的矫正训练、日常生活和姿势的管理。运动训练每周4-5次，每次训练时间30-40min。同时，配合每日穿戴支具。

干预措施代码：

Intervention：

PSSE training was arranged according to the type of the patient's lateral curvature and the size of the Cobb Angle of the lateral curvature. The training contents included: spiral angular breathing, three-dimensional plane correction training, daily life and posture management. Exercise training 4-5 times a week, each training time 30-40min. At the same time, with daily wear brace.

Intervention code：

组别：

健康对照组

样本量：

 30

Group：

Healthy control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

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)：

 昆明 

Country：

China

Province：

Yunnan

City：

Kunming

单位(医院)：

 昆明医科大学第二附属医院 

单位级别：

 Tertiary A 

Institution
hospital：

The Second Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Cobb角

指标类型：

主要指标

Outcome：

Cobb angle

Type：

Primary indicator

测量时间点：

干预前、干预3个月、干预6个月

测量方法：

评估AIS严重程度的主要指标

Measure time point of outcome：

Before intervention, intervention for 3 months, intervention for 6 months

Measure method：

The main indicators for assessing the severity of AIS

指标中文名：

近红外评估

指标类型：

主要指标

Outcome：

Near infrared evaluation

Type：

Primary indicator

测量时间点：

干预前、干预3个月、干预6个月

测量方法：

使用 fNIRS 系统( NirSmart，慧创医疗设备有限公司) ，采用连续波激光二极管记录皮层活动。受试者戴好 fNIRS 配套的光学探查头帽，取站立位，双上肢静置于身体两侧，双下肢伸直，待熟悉环境后开始试验。

Measure time point of outcome：

Before intervention, intervention for 3 months, intervention for 6 months

Measure method：

Using the fNIRS system (NirSmart), continuous wave laser diodes are used to record cortical activity. The subjects put on the optical probing head cap matched with fNIRS, took a standing position, placed their upper limbs on both sides of the body, and extended their lower limbs, and began the experiment after getting familiar with the environment.

指标中文名：

表面肌电

指标类型：

主要指标

Outcome：

Surface electromyography

Type：

Primary indicator

测量时间点：

干预前、干预3个月、干预6个月

测量方法：

采用表面肌电仪(美国 NORAXON 公司)，采集6个表面肌电（3对）。待皮肤干燥后，将电极片沿肌纤维走向粘贴，AIS受试者：主弯顶椎左右旁开脊柱2cm、次弯顶椎左右旁开脊柱2cm、左右腹肌（脐水平）；健康受试者：T4顶椎左右旁开脊柱2cm、L2顶椎左右旁开脊柱2cm、左右腹肌（脐水平）。

Measure time point of outcome：

Before intervention, intervention for 3 months, intervention for 6 months

Measure method：

Surface electromyograph (NORAXON Company, USA) was used to collect 6 surface electromyography (3 pairs). After the skin was dry, the electrodes were attached along the muscle fibers. AIS subjects: the left and right paraventure spine of the main curved top vertebra was 2cm, the left and right paraventure spine of the secondary curved top vertebra was 2cm, and the left and right abdominal muscles (umbilical level); Healthy subjects: T4 parietal spine 2cm, L2 parietal spine 2cm, left and right a

指标中文名：

平衡功能的评估

指标类型：

主要指标

Outcome：

Assessment of balance function

Type：

Primary indicator

测量时间点：

干预前、干预3个月、干预6个月

测量方法：

采用TecnoBody平衡和本体感觉评估训练仪进行患者稳定极限的评估，可评估患者在8个象限的静态和动态平衡参数。

Measure time point of outcome：

Before intervention, intervention for 3 months, intervention for 6 months

Measure method：

The TecnoBody Balance and proprioceptive evaluation trainer was used to evaluate the patient's stability limits, which allowed the assessment of the patient's static and dynamic balance parameters in 8 quadrangles.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

no

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 10 岁 years
最大 Max age 18 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）：

该课题由研究者和研究助理进行受试者的招募，招募的方式包括伦理通过后在医院和学校发布招募的广告。在90个信封内，分装随机化结果：在标记编号为001的信封内放入分组为A组的纸片，在标记编号为002的信封内放入分组为A组的纸片，在标记编号为003的信封内放入分组为C组的纸片，信封分装完成后，将信封发放给研究实施人员。出现第1例患者时，根据纳入排除标准判断是否纳入研究，如纳入则拆开001号信封。此时该患者的研究对象编号为001，组别为A组。

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

Participants were recruited by researchers and research assistants, including through the Posting of recruitment advertisements in hospitals and schools after ethical approval. In the 90 envelopes, the results of the randomization of the packaging were as follows: the paper in group A was placed in the envelope marked 001, the paper in group A was placed in the envelope marked 002, and the paper in group C was placed in the envelope marked 003, and the envelopes were distributed to the research implementation personnel after the envelopes were completed. When the first patient appeared, the inclusion and exclusion criteria were used to determine whether the patient was included in the study. If so, envelope No. 001 was opened. At this time, the patient's study object number was 001 and the group was Group A.

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：

该研究遵循双盲原则，对评估人员、干预者、受试者使用盲法。

Blinding：

The study followed the double-blind principle, using blind methods for evaluators, interveners and subjects.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

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：

在进行数据采集之前，研究人员会提前明确研究目的和问题，并设计相应的研究方法和工具。同时，研究人员会遵伦理原则，确保数据的获得过程符合伦理规范，保护被调查者的权益和隐私。在进行数据质控时，研究人员会注意数据的一致性、完整性、有效性和可靠性，排除数据中的错误和异常值。此外，为了确保数据的质量和可靠性，研究人员会采取其他措施，如进行数据重复性测试、使用多种数据源进行比较和验证、进行数据交叉检验等。同时，研究人员还需要对数据进行保密处理，确保数据的安全性和隐私性。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Before data collection, researchers will clarify the research purpose and problem in advance, and design the corresponding research methods and tools. At the same time, researchers will comply with ethical principles to ensure that the process of obtaining data is ethical and protects the rights and privacy of respondents. When conducting data quality control, researchers will pay attention to the consistency, integrity, validity and reliability of the data, and eliminate errors and outliers in the data. In addition, in order to ensure the quality and reliability of the data, the researchers will take other measures, such as conducting data repeatability tests, using multiple data sources for comparison and verification, and conducting data cross-checks. At the same time, researchers also need to keep the data confidential to ensure the security and privacy of the data.

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：

  2023-09-19 15:42:19