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

NCT06758115 | Recruiting

• 1 other identifier: 2024-KL-504-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pro-Kin Balance System

  Before treatment, and at 4 weeks and 12 weeks after treatment.

Study Arms (2)

AIS

Procedure: Tuina (Massage) Therapy

Healthy Control Group

Procedure: Tuina (Massage) Therapy

Interventions

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.

AIS; Healthy Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adolescent Idiopathic Scoliosis Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

the First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, China

RECRUITING

MeSH Terms

Interventions

Massage; Therapeutics

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)