NCT06758115 Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis
| NCT ID | NCT06758115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Zhejiang Chinese Medical University |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-01-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06758115 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06758115 currently recruiting?
Yes, NCT06758115 is actively recruiting participants. Visit ClinicalTrials.gov or contact The First Affiliated Hospital of Zhejiang Chinese Medical University to inquire about joining.
Where is the NCT06758115 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06758115 clinical trial?
NCT06758115 is sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. The trial plans to enroll 40 participants.