Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Tuina (Massage) Therapy
  Operation Method: Correct abnormal joint alignment - Manipulatively realign the vertebral segments and pelvis affected by scoliosis. Correct abnormal muscle function - After realigning the vertebral bodies to their normal position, stretch the corresponding tight and shortened muscles while strengthening the muscles that need to be lengthened. Restore joint stability - After adjusting the vertebrae and muscles, instruct the patient to hold the corrected posture for at least 10 seconds, then r

Первичные конечные точки

• HD-EMG [Срок оценки: Before treatment, and at 4 weeks and 12 weeks after treatment.]

Вторичные конечные точки (1)

• Pro-Kin Balance System [Срок оценки: Before treatment, and at 4 weeks and 12 weeks after treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• the First Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

NCT: NCT06758115 · 2024-KL-504-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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