Brief Summary

Mining AIS biomarkers, elucidating the new mechanism of AIS pathogenicity, constructing risk prediction models, optimizing AIS precise diagnosis and treatment techniques, formulating precise diagnosis and treatment protocols and technical specifications for AIS combined with Chinese and Western medicine with independent intellectual property rights, and realizing the full coverage of Zhejiang Province by the end of 2026, so as to form the "Zhejiang experience" of AIS diagnosis and treatment.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,000

participants targeted

Target at P75+ for not_applicable

Timeline

7mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Progress74%

Sep 2024Dec 2026

First Submitted

Initial submission to the registry

June 30, 2024

Completed

17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 17, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

June 30, 2024

Last Update Submit

July 16, 2024

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (18)

Cobb Angle
Cobb's angle is an angle used to measure the severity of scoliosis by measuring the angle of lateral curvature to assess the degree of scoliosis.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Trunk Rotation Degree -Angle of Trunk Rotation
The patient stood with feet shoulder-width apart and bent forward with hands to palms, and the maximum degree of spinal razorback was measured with the Scoliometer Scoliosis Screening Scale.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Coronal Balance
A plumb line is usually used to determine coronal plane balance. In the coronal plane of a normal spine, a plumb line leading from the center of the C7 vertebra will pass through the center of the sacrum or within 1 cm to the left and right of the S1 spinous process.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Sagittal Balance
Sagittal Balanced descriptions in the sagittal plane are an important way to assess scoliosis and its impact on body structure and function.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Frontal Convexity Of the Spine Angle
Your doctor will ask you to stand or sit down and then take x-ray pictures of your spine from the side. These pictures show the curve and curvature of the spine, from which the doctor can assess the condition of the lordosis.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Offside Convexity Of the Spine Angle
Your doctor will ask you to stand or sit down and then take x-ray pictures of your spine from the side. These pictures clearly show the curve and curvature of the spine, and the doctor can use these images to evaluate the condition of the kyphosis.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Electromyographic (AEMG) indicators
The obtained surface EMG signal data were input into MegaWin 2.3 signal processing software to extract and analyze linear metrics (mean frequency, median frequency, muscle activity intensity, etc.), and nonlinear metrics (multi-scale sample entropy, fractal dimension, coherence, etc.)
Pre-treatment, 3, 6, 9, 12 months post-treatment
Electroencephalographic (EEG) Index
Matlab based software and its toolkit EEGLAB were used to preprocess the data and get clean EEG signal. The effective number of channels acquired in this study was 18 leads. Fifteen 2s segments (i.e., 45s of data) were randomly selected for each subject to obtain δ (1-4Hz), θ (4-8Hz), α (8-13Hz), and β (13-30Hz), and the functional connectivity of the different bands was calculated separately.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Postural Posture Assessment
Measurements of trunk offset angle, pelvic tilt angle, thoracic lordosis angle, lumbar lordosis angle, the sum of the maximum angle of vertebral body left-right rotation, the sum of the maximum left-right deviation of the trunk, and the angle of primary bending and lateral curvature can be obtained after completion of the filming.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Balance Function
Subjects remained stationary with eyes open for 30 seconds, and four parameters of COP were recorded: area of COP oscillation, mean oscillation velocity in the anteroposterior (AP) and medial-lateral (ML) directions, and length of movement.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Questionnaire on Spinal Health of Children and Adolescents
The Spine Health Questionnaire for Children and Adolescents is designed to understand and assess the spine health status and related behaviors of this age group in their daily lives.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Skeletal maturity (Risser's sign)
Doctors determine a child's bone age based on the closest standard x-ray image in the atlas to how the child's bones appear on the x-ray.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Types of scoliosis
Although scoliosis presents all lateral curvature and vertebral rotation in the spinal phase, we can categorize it into different types based on the number of degrees of scoliosis when the degree of scoliosis is greater than ten degrees in the online screen slice mountain.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Sagittal plane axial distance (SVA)
Sagittal plane axial distance (SVA) is one of the most important indicators of spinal and body postural balance, especially when assessing anterior-posterior spinal balance. It is usually measured by imaging (e.g., X-rays or MRI) and is used to quantify the anterior-posterior positional differences between the head and a pelvis.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Muscle and bone ultrasound
Morphological characteristics of the paravertebral muscles were extracted by ultrasonography of the morphology and elasticity of the paravertebral muscles of the enrolled patients.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Number of participants with Chemical testing
Subjects were obtained for routine blood, urine, biochemistry, thyroid function, sex hormones, allergens, growth hormone, leptin, estrogen, melatonin, and other tests.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Number of participants with Blood samples
Venous blood samples were collected from all included patients at 5 mL per person.The obtained blood samples were placed at -8°C. Samples were immediately separated, partitioned and stored after collection, and some blood samples were immediately sent to the hospital for biochemical indexes.
Pre-treatment, 3, 6, 9, 12 months post-treatment
Urine test
Drink little or no water before going to bed, and try to retain urine in the bladder for more than 4 hours, use a sterile wide-mouth container to collect, discard the anterior part of the urine, and retain about 10mL of the middle part of the urine into a sterile container, and send it to the test immediately.
Pre-treatment, 3, 6, 9, 12 months post-treatment

Study Arms (2)

according to the order of their visits then were assigned numbers

EXPERIMENTAL

The patients were assigned numbers according to the order of their visits, and after obtaining informed consent, they were divided into a treatment group and a control group to conduct a prospective cohort study.

Behavioral: Low risk experimental groupBehavioral: Medium risk experimental groupGenetic: High risk experimental groupBehavioral: Control group COBB 10-20°Behavioral: Control group COBB 20-45°Behavioral: Control group COBB >45°Other: Experimental group (AIS group)Other: Control group (healthy control)Other: Controlled follow-up before and after AIS

According to the order of their visits to the clinic, given the appropriate number,

EXPERIMENTAL

According to the order of their visits to the clinic, given the appropriate number, divided into the test group and the control group, in strict accordance with the results of the group, the appropriate treatment and observation of the group, the teams of personnel and the implementation of clinical treatment should not be the same person.