跳至主要内容
临床试验/NCT06758115
NCT06758115招募中不适用

Study on the Central Motor Regulation Mechanism in Adolescent Idiopathic Scoliosis (AIS) Patients Based on HD-sEMG, EEG, and Neuromuscular Coupling Analysis

The First Affiliated Hospital of Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
HD-EMG

研究概览

简要总结

  1. Verifying the Motor Control Effects of Spinal Manipulation on AIS Using outpatient and inpatient AIS patients from our department as the study subjects, standardized spinal manipulation treatment is applied. The efficacy is evaluated through a combination of clinical outcome measures, HD-EMG for paraspinal muscle function assessment, and Pro-Kin balance system for trunk stability analysis. This establishes an AIS efficacy platform to further clarify the effectiveness of spinal manipulation in motor control regulation of AIS.
  2. Investigating the Central Motor Network's Response to Spinal Manipulation in AIS Utilizing high-density sEMG-EEG technology, synchronized brain and muscle electrical signals are collected before and after treatment. By employing a neuromuscular synchronization and coupling analysis approach that integrates linear and nonlinear methods, the characteristic indices of information interaction between the central system and muscles are identified. This further explores the motor control and response characteristics of the muscle-cortex network to spinal manipulation in AIS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged ≥10 years;
  • •Risser sign grade 0-3;
  • •Cobb angle between 10° and 40°;
  • •No prior treatment;
  • •Female patients within 1 year after menarche or before menstruation;
  • •The patient's guardian signs the informed consent form for treatment.

排除标准

  • •Those who do not meet the diagnostic criteria for AIS or inclusion criteria;
  • •Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system disorders, or those with mental illnesses;
  • •Patients with thrombocytopenia, coagulation disorders, or a tendency to bleed;
  • •Patients who are afraid of the treatment and cannot tolerate it;
  • •Those who have already received other treatments that may affect the study's outcome measures.

结局指标

主要结局

HD-EMG

时间窗: Before treatment, and at 4 weeks and 12 weeks after treatment.

Muscle performance was assessed using the SAGA high-density electromyography (EMG) system to evaluate the function and activity of the paraspinal muscles.

次要结局

  • Pro-Kin Balance System(Before treatment, and at 4 weeks and 12 weeks after treatment.)

研究者

发起方
The First Affiliated Hospital of Zhejiang Chinese Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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