Research on Key Technologies for Risk Prediction and Precise Diagnosis and Treatment of AIS Based on Epigene-phenotype
NCT Number: NCT06506227
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adolescent Idiopathic Scoliosis
Interventions: BEHAVIORAL: Low risk experimental group|BEHAVIORAL: Medium risk experimental group|GENETIC: High risk experimental group|BEHAVIORAL: 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
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 2000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Prokin balance apparatus, Hangzhou, Zhejiang, 310006, China

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.

Primary Outcome Measures: 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