Screening and Intervention for AIS in Haikou, Hainan Province, China

August 1, 2023 updated by: Chaoyin Jiang

Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China

This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. The patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. Patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hainan
      • Haikou, Hainan, China, 570300
        • Recruiting
        • Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital
        • Contact:
          • Chaoyin Jiang, MD
        • Principal Investigator:
          • Chaoyin Jiang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 9 years ≤ age ≤ 16 years
  2. Diagnosis of AIS
  3. 10°≤Cobb's angle<45°
  4. Signed informed consent form

Exclusion Criteria:

  1. With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders
  2. Obvious deformity of lower limbs and(or) feet
  3. Previous or ongoing treatment of AIS
  4. Difficulty to read, understanding, and complete the study questionnaires
  5. Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: recommend exercise - perference exercise
Behavioral: Exercise
Exercise rehabilitation with Schroth method
Active Comparator: recommend exercise - perference brace
Device: Brace
Wear an orthopedic brace
No Intervention: recommend exercise - perference observation
Active Comparator: recommend brace - perference brace
Device: Brace
Wear an orthopedic brace
Active Comparator: recommend brace - perference exercise
Behavioral: Exercise
Exercise rehabilitation with Schroth method
No Intervention: recommend brace - perference observation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Out-of-control rate of treatment
Time Frame: 36 months
Among the patients with skeletal immaturity (Risser's sign 0, 1, 2), out-of-control rate of treatment at the follow-up to 36 months or at skeletal maturity during the trial (i.e., 4° for female Risser's sign or 5° for male Risser's sign). Out-of-control rate of treatment is defined as either: Cobb angle progression >5°, or Cobb angle ≥45°, or the physician recommends or already has enhanced the intervention regimen (i.e., no intervention change to exercise intervention, no intervention change to brace intervention, or exercise intervention change to brace intervention).
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: 36 months
The incidence of adverse events for the intervention
36 months
Change in SRS-22 score from baseline over time
Time Frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in quality of life (SRS-22 score) from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in vital capacity from baseline over time
Time Frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in vital capacity from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment.
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in plantar pressure from baseline over time
Time Frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in plantar pressure from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months after treatment compared with those before treatment.
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in gait from baseline over time
Time Frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in gait from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Correlation between the treatment compliance and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment
36 months
Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the skeletal maturity (Risser's sign) at baseline and the out-of-control rate of treatment
36 months
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
36 months
Correlation between the immediate correction and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the immediate correction [(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle] and the out-of-control rate of treatment
36 months
The change in Cobb angle from baseline over time
Time Frame: 36 months
The change in Cobb angle from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
36 months
Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline
36 months
Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline
36 months
Correlation between the immediate correction and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the immediate correction [(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle] and the change in 36-month Cobb angle from baseline
36 months
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
36 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between the age and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the patient's age and the out-of-control rate of treatment
36 months
Correlation between the BMI at baseline and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the patient's BMI (kg/m^2) at baseline and the out-of-control rate of treatment
36 months
Correlation between the type of AIS and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the type of AIS and the out-of-control rate of treatment
36 months
Correlation between the types of braces and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the types of braces and the out-of-control rate of treatment
36 months
Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the average time (hours) spent doing homework per day at baseline and the out-of-control rate of treatment
36 months
Correlation between the vitamin D content at baseline and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the serum 25(OH)D (nmol/L) at baseline and the out-of-control rate of treatment
36 months
Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment
Time Frame: 36 months
Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment
36 months
Correlation between the age and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the patient's age and the change in 36-month Cobb angle from baseline
36 months
Correlation between the BMI at baseline and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the patient's BMI (kg/m^2) at baseline and the change in 36-month Cobb angle from baseline
36 months
Correlation between the type of AIS and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the type of AIS and the change in 36-month Cobb angle from baseline
36 months
Correlation between the types of braces and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the types of braces and the change in 36-month Cobb angle from baseline
36 months
Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the average time (hours) spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline
36 months
Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the serum 25(OH)D (nmol/L) at baseline and the change in 36-month Cobb angle from baseline
36 months
Correlation between the average time spent doing outdoor exercise after school per day at baseline and the change in 36-month Cobb angle from baseline
Time Frame: 36 months
Correlation between the average time (hours) spent doing outdoor exercise after school per day at baseline and the change in 36-month Cobb angle from baseline
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chaoyin Jiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GTYN2022001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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