ChiCTR2300074016 版本V1.0 版本创建时间2023/07/27 14:52:45 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：

 ChiCTR2300074016 

最近更新日期：

Date of Last Refreshed on：

 2023-07-27 14:51:26 

注册时间：

Date of Registration：

 2023-07-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

青少年特发性脊柱侧弯患者 Y-balance姿势控制的表面肌电和近红外脑功能成像研究

Public title：

Surface electromyography and near-infrared functional brain imaging of Y-balance postural control in adolescent patients with idiopathic scoliosis

注册题目简写：

AIS 患者 Y-balance姿势控制的表面肌电和近红外脑功能成像研究

English Acronym：

Surface electromyography and near-infrared functional brain imaging of Y-balance postural control in AIS patients

研究课题的正式科学名称：

AIS 患者 Y-balance姿势控制的表面肌电和近红外脑功能成像研究

Scientific title：

Surface electromyography and near-infrared functional brain imaging of Y-balance postural control in AIS patients

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：

Li kerong 

Study leader：

Meng Fanyuan 

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：

 KMMU2023MEC156

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：

昆明医科大学研究生创新基金

Source(s) of funding：

Kunming Medical University graduate Student Innovation Fund

研究疾病：

脊柱侧弯  

Target disease：

scoliosis

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

1）研究AIS患者对比健康人群，单脚动态稳定极限的差异，分析AIS患者是否存在核心稳定，前庭、视觉、本体、神经肌肉控制整合能力的受限。 2）AIS患者在静止站立、Y-balance任务中，脊柱凸凹侧椎盘肌和腹肌的表面肌电，分析侧弯患者在姿势控制中核心肌群的激活情况。 3）分析AIS患者对比健康人群在Y-balance任务中大脑皮层的激活情况  

Objectives of Study：

1) Study the difference of dynamic stability limit of one foot in AIS patients compared with healthy people, and analyze whether AIS patients have limitations in core stability, vestibular, visual, proprioceptive and neuromuscular control integration. 2) In AIS patients standing still and Y-balance tasks, surface electromyography of disc muscles and abdominal muscles on the convex and concave side of the spine was used to analyze the activation of core muscles in posture control in patients with lateral curvature. 3) The cerebral cortex activation of AIS patients compared with healthy people in Y-balance task was analyzed

药物成份或治疗方案详述：

在一个安静、宽阔、明亮的环境下完成Y-balance测试，测试前受试者热身，粘贴表面肌电、佩戴近红外头套。 Y-balance测试 动作一：受试者赤足，单腿支撑站立于贴有YBT运动套件的测力台上，拇趾在中心横线后，对准正前方，双手叉腰；测试开始，受试者静止站立10s,非支撑腿按前侧、后外侧和后内侧顺序依次伸展，每个方向伸展1次后,回到双脚站立，静息10s后，换下一个方向，测量伸展的最大距离，精确到0.5 cm，此动作测试完毕后，更换支撑侧再重复测试。 动作二：受试者赤足，单腿支撑站立于贴有YBT运动套件的测力台上，拇趾在中心横线后，对准正前方，双手打开；测试开始，受试者静止站立10s,非支撑腿按前侧、后外侧和后内侧顺序依次伸展，每个方向伸展1次后,回到双脚站立，静息10s后，换下一个方向，测量伸展的最大距离，精确到0.5 cm，此动作测试完毕后，更换支撑侧再重复测试。 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）。 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。 

Description for medicine or protocol of treatment in detail：

Y-balance test was completed in a quiet, wide and bright environment. Before the test, subjects warmed up, pasted surface electromyography and wore near-infrared headgear. Y-balance test Action 1: The subject stands on the force measuring table attached with YBT exercise kit with bare feet and one leg support. The big toe is behind the center horizontal line, aligned with the front, and the hands are on the waist; At the beginning of the test, subjects stood still for 10s and extended their non-supporting legs in the order of front side, posterolateral side and posterolateral side successively. After stretching once in each direction, they returned to standing with their feet. After resting for 10s, they changed the direction to measure the maximum distance of extension, accurate to 0.5cm. Action 2: The subject stands on the force measuring table attached with YBT exercise kit with bare feet and one leg support. The big toe is behind the center horizontal line, aligned with the front, and the hands are open. At the beginning of the test, subjects stood still for 10s and extended their non-supporting legs in the order of front side, posterolateral side and posterolateral side successively. After stretching once in each direction, they returned to standing with their feet. After resting for 10s, they changed the direction to measure the maximum distance of extension, accurate to 0.5cm. 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 abdominal muscles (umbilical level). 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.  

纳入标准：

纳入标准 ①临床评估和综合影像学检查确诊为青少年特发性脊柱侧弯，符合青少年特发性脊柱侧弯诊断标准； ②Cobb角＞10°； ③患者知情同意； ④年龄10-18周岁，男女不限； ⑤无认知障碍或交流障碍。

Inclusion criteria

① Clinical evaluation and comprehensive imaging examination confirmed the diagnosis of adolescent idiopathic scoliosis, which met the diagnostic criteria of adolescent idiopathic scoliosis; ②Cobb Angle > 10°; ③ Patient's informed consent; ④ Age 10-18 years old, male and female; ⑤ No cognitive impairment or communication impairment.

排除标准：

①合并其他慢性疾病患者（可导致生长发育受影响）； ②经手术治疗的AIS患者； ③有肌肉骨骼功能异常、神经系统疾病、严重内脏病变、严重代谢性疾病或骨肿瘤。

Exclusion criteria：

① Patients with other chronic diseases (can cause growth and development to be affected); ② AIS patients treated with surgery; ③ There are musculoskeletal abnormalities, neurological diseases, severe visceral diseases, severe metabolic diseases, or bone tumors.

研究实施时间：

Study execute time：

从 From 2023-08-01 00:00:00至 To 2023-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-01 00:00:00 至 To 2023-11-01 00:00:00

干预措施：

Interventions：

组别：

健康组

样本量：

 30

Group：

Health group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

AIS组

样本量：

 30

Group：

AIS 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：

 三甲 

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：

表面肌电

指标类型：

主要指标

Outcome：

Surface electromyography,

Type：

Primary indicator

测量时间点：

确诊为AIS后

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：

After diagnosis of AIS

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：

近红外

指标类型：

主要指标

Outcome：

near-infrared

Type：

Primary indicator

测量时间点：

确诊为AIS后

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：

After diagnosis of AIS

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.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

none

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

none

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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

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）：

因涉及受试者隐私，不公开原始数据

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

The original data will not be disclosed due to the subject's privacy

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：

从以下四个方面保证数据的质量控制： 数据完整性：数据是否存在缺失记录或者缺失字段。 数据及时性：数据的产生以及供给是否及时。 数据有效性：数据是否满足用户定义的约束条件或者是否在一定的取值范围之内。 数据准确性：数据是否与其对应的客观实体特征保持一致。 数据一致性：同一实体同一属性的数据在不同的系统中是否一致。

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

Data quality control is ensured from the following four aspects: Data integrity: Whether data has missing records or missing fields. Data timeliness: Whether data is generated and supplied in a timely manner. Data validity: Whether the data meets user-defined constraints or is within a certain value range. Data accuracy: Whether the data is consistent with the characteristics of its corresponding objective entity. Data consistency: Whether data of the same entity with the same attribute is consistent in different systems.

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：

  2023-07-27 14:51:26