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

AIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466383
• Other study ID #: GTYN2022001
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Shanghai 6th People's Hospital
• Contact: Chaoyin Jiang, MD
• Phone: +8689868603821
• Email: Jiangdoctor1979[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• AIS

Intervention

Behavioral:
• Exercise
Exercise rehabilitation with Schroth method

Device:
• Brace
Wear an orthopedic brace

Locations

Country	Name	City	State
China	Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Chaoyin Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	36 months
Other	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	36 months
Other	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	36 months
Other	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	36 months
Other	Correlation between the average time spent doing homework per day at baseline and the out-of-control rate of treatment	Correlation between the average time (hours) spent doing homework per day at baseline and the out-of-control rate of treatment	36 months
Other	Correlation between the vitamin D content at baseline and the out-of-control rate of treatment	Correlation between the serum 25(OH)D (nmol/L) at baseline and the out-of-control rate of treatment	36 months
Other	Correlation between the average time spent doing outdoor exercise after school per day at baseline and the out-of-control rate of treatment	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
Other	Correlation between the age and the change in 36-month Cobb angle from baseline	Correlation between the patient's age and the change in 36-month Cobb angle from baseline	36 months
Other	Correlation between the BMI at baseline and the change in 36-month Cobb angle from baseline	Correlation between the patient's BMI (kg/m^2) at baseline and the change in 36-month Cobb angle from baseline	36 months
Other	Correlation between the type of AIS and the change in 36-month Cobb angle from baseline	Correlation between the type of AIS and the change in 36-month Cobb angle from baseline	36 months
Other	Correlation between the types of braces and the change in 36-month Cobb angle from baseline	Correlation between the types of braces and the change in 36-month Cobb angle from baseline	36 months
Other	Correlation between the average time spent doing homework per day at baseline and the change in 36-month Cobb angle from baseline	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
Other	Correlation between the vitamin D content at baseline and the change in 36-month Cobb angle from baseline	Correlation between the serum 25(OH)D (nmol/L) at baseline and the change in 36-month Cobb angle from baseline	36 months
Other	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	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
Primary	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).	36 months
Secondary	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	at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Secondary	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.	at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Secondary	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.	at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Secondary	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	at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Secondary	Correlation between the treatment compliance and the out-of-control rate of treatment	Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment	36 months
Secondary	Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment	Correlation between the skeletal maturity (Risser's sign) at baseline and the out-of-control rate of treatment	36 months
Secondary	Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment	Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment	36 months
Secondary	Correlation between the immediate correction and the out-of-control rate of treatment	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
Secondary	The incidence of adverse events	The incidence of adverse events for the intervention	36 months
Secondary	The change in Cobb angle from baseline over time	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
Secondary	Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline	Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline	36 months
Secondary	Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline	Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline	36 months
Secondary	Correlation between the immediate correction and the change in 36-month Cobb angle from baseline	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
Secondary	Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline	Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline	36 months