Screening and Intervention for AIS in Haikou, Hainan Province, China
ConditionAIS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-16
SponsorChaoyin Jiang
About this trial
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.
Eligibility criteria
Qualifiers
9 years ≤ age ≤ 16 years
Diagnosis of AIS
10°≤Cobb's angle<45°
Signed informed consent form
Disqualifiers
With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders
Obvious deformity of lower limbs and(or) feet
Previous or ongoing treatment of AIS
Difficulty to read, understanding, and complete the study questionnaires
Trial design
Treatments tested in this trial
- Exercise
- Brace
Treatment groups
5,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Chaoyin Jiang
Lead sponsor
Shanghai 6th People's Hospital
Sponsor institution
Source ClinicalTrials.gov