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

Chaoyin Jiang

Status: Enrolling

Conditions: AIS

Treatments: Device: Brace; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05466383

GTYN2022001

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5,000 participants in 6 patient groups

recommend exercise - perference exercise

Active Comparator group

Treatment:

Behavioral: Exercise

recommend exercise - perference brace

Active Comparator group

Treatment:

Device: Brace

recommend exercise - perference observation

No Intervention group

recommend brace - perference brace

Active Comparator group

Treatment:

Device: Brace

recommend brace - perference exercise

Active Comparator group

Treatment:

Behavioral: Exercise

recommend brace - perference observation

No Intervention group