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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Chaoyin Jiang, MD; Zhenyu Wang, Ph.D

Data sourced from clinicaltrials.gov

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