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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Exercise
BehavioralExercise rehabilitation with Schroth method
Brace
DeviceWear an orthopedic brace
Treatment groups
5,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: recommend exercise - perference exerciseActive comparator 1 intervention
Group B: recommend exercise - perference braceActive comparator 1 intervention
Group C: recommend exercise - perference observationNo intervention 0 interventions
Group D: recommend brace - perference braceActive comparator 1 intervention
Group E: recommend brace - perference exerciseActive comparator 1 intervention
Group F: recommend brace - perference observationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Out-of-control rate of treatment
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).
Time frame
36 monthsSecondary outcomes
1
Change in SRS-22 score from baseline over time
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
Time frame
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment2
Change in vital capacity from baseline over time
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.
Time frame
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment3
Change in plantar pressure from baseline over time
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.
Time frame
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment4
Change in gait from baseline over time
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
Time frame
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatmentOther outcomes
1
Correlation between the age and the out-of-control rate of treatment
Correlation between the patient's age and the out-of-control rate of treatment
Time frame
36 months2
Correlation between the BMI at baseline and the out-of-control rate of treatment
Correlation between the patient's BMI (kg/m\^2) at baseline and the out-of-control rate of treatment
Time frame
36 months3
Correlation between the type of AIS and the out-of-control rate of treatment
Correlation between the type of AIS and the out-of-control rate of treatment
Time frame
36 months4
Correlation between the types of braces and the out-of-control rate of treatment
Correlation between the types of braces and the out-of-control rate of treatment
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chaoyin Jiang
Lead sponsor
Shanghai 6th People's Hospital
Sponsor institution
Source ClinicalTrials.gov