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

Study on the Central Motor Regulation Mechanism in Adolescent Idiopathic Scoliosis (AIS) Patients Based on 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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Procedure: Tuina (Massage) Therapy

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhejiang Chinese Medical University
    • Contact: Honggen Du; Phone Number: 13958088996; Email: 1165374551@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adolescent Idiopathic Scoliosis Patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control Group	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 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.
AIS	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HD-EMG	Muscle performance was assessed using the SAGA high-density electromyography (EMG) system to evaluate the function and activity of the paraspinal muscles.	Before treatment, and at 4 weeks and 12 weeks after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-Kin Balance System	The Pro-Kin Balance System was used to assess trunk stability and evaluate motor control ability.	Before treatment, and at 4 weeks and 12 weeks after treatment.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2024-KL-504-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No