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Recruiting NCT06758115

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

Observational Adolescent Idiopathic Scoliosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tuina (Massage) Therapy.
Who it may be relevant to
Registry conditions: Adolescent Idiopathic Scoliosis. Basic parameters: 10 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • HD-EMG [Time frame: Before treatment, and at 4 weeks and 12 weeks after treatment.]
Secondary outcome measures (1)
  • Pro-Kin Balance System [Time frame: Before treatment, and at 4 weeks and 12 weeks after treatment.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou

Identifiers

NCT: NCT06758115 · 2024-KL-504-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗