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NCT Number: NCT06758115

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, China

Location status: Recruiting

Location contact

Honggen Du

CONTACT

[email protected]

13958088996

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tuina (Massage) Therapy

Procedure

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 relax for 10 seconds. Repeat this cycle 3-5 times.

Restore sensorimotor control - Provide appropriate movement disturbances to patients maintaining the corrected posture to enhance proprioception and motor memory in the corresponding muscles.

The total duration of the manipulation is 20-25 minutes. Treatment is performed twice a week for a total of 12 weeks.

Primary outcomes

  1. HD-EMG

    Time frame: 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.

Secondary outcomes

  1. Pro-Kin Balance System

    Time frame: Before treatment, and at 4 weeks and 12 weeks after treatment.

    The Pro-Kin Balance System was used to assess trunk stability and evaluate motor control ability.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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