Adolescent Idiopathic ScoliosisNCT06758115
Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis
An observational study of Adolescent Idiopathic Scoliosis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Tuina (Massage) Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent Idiopathic Scoliosis Patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou
Honggen Du, 13958088996, 1165374551@qq.com
About this study
Official title: Study on the Central Motor Regulation Mechanism in Adolescent Idiopathic Scoliosis (AIS) Patients Based on HD-sEMG, EEG, and Neuromuscular Coupling Analysis
- 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.
- 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
- Being tested
- Tuina (Massage) Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuina (Massage) TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| AIS | Not described Receives: Procedure: Tuina (Massage) Therapy | |
| Healthy Control Group | Not described Receives: Procedure: Tuina (Massage) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HD-EMG
Muscle performance was assessed using the SAGA high-density electromyography (EMG) system to evaluate the function and activity of the paraspinal muscles.
Measured: Before treatment, and at 4 weeks and 12 weeks after treatment.
Secondary outcomes (1)
Pro-Kin Balance System
The Pro-Kin Balance System was used to assess trunk stability and evaluate motor control ability.
Measured: Before treatment, and at 4 weeks and 12 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758115
- Sponsor's protocol ID
- 2024-KL-504-02
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Central Motor Regulation Mechanism in Adolescent Idiopathic Scoliosis (AIS) Patients Based on HD-sEMG, EEG, and Neuromuscular Coupling Analysis
- ClinicalTrials.gov ID
- NCT06758115
- Acronym / sponsor ID
- 2024-KL-504-02
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS | – | Procedure: Tuina (Massage) Therapy |
| Healthy Control Group | – | Procedure: Tuina (Massage) Therapy |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent Idiopathic Scoliosis Patients
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuina (Massage) TherapyOperation 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. | Procedure or surgery | AIS, Healthy Control Group |
Primary outcome
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.
1 secondary outcome
Pro-Kin Balance System
Time frame: Before treatment, and at 4 weeks and 12 weeks after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
the First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HD-EMG (time frame: Before treatment, and at 4 weeks and 12 weeks after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.